Acura Pharmaceuticals（ACUR）株式概要アキュラ・ファーマシューティカルズ社は、革新的なドラッグ・デリバリー企業であり、米国において医薬品の安全な使用に取り組むための技術と製品の研究、開発、商業化に従事している。 詳細ACUR ファンダメンタル分析スノーフレーク・スコア評価0/6将来の成長0/6過去の実績0/6財務の健全性0/6配当金0/6リスク分析株式の流動性は非常に低い 最新の財務報告は1年以上前のものである 意味のある時価総額がありません ( $13K )すべてのリスクチェックを見るACUR Community Fair Values Create NarrativeSee what others think this stock is worth. Follow their fair value or set your own to get alerts.Your Fair ValueUS$Current PriceUS$0.000299.6% 割安 内在価値ディスカウントGrowth estimate overAnnual revenue growth rate5 Yearstime period%/yrDecreaseIncreasePastFuture-7m9m2016201920222025202620282031Revenue US$1.6mEarnings US$229.8kAdvancedSet Fair ValueView all narrativesAcura Pharmaceuticals, Inc. 競合他社AmeriCannSymbol: OTCPK:ACANMarket cap: US$4.9kPetros PharmaceuticalsSymbol: OTCPK:PTPIMarket cap: US$257.9kEcofibreSymbol: OTCPK:EOFB.FMarket cap: US$366.6kAltamira TherapeuticsSymbol: OTCPK:CYTO.FMarket cap: US$641.7k価格と性能株価の高値、安値、推移の概要Acura Pharmaceuticals過去の株価現在の株価US$0.000252週高値US$0.0152週安値US$0.0001ベータ01ヶ月の変化0%3ヶ月変化n/a1年変化n/a3年間の変化-99.60%5年間の変化-99.90%IPOからの変化-99.90%最新ニュースお知らせ • May 14Acura Pharmaceuticals, Inc. announced delayed 10-Q filingOn 05/13/2026, Acura Pharmaceuticals, Inc. announced that they will be unable to file their next 10-Q by the deadline required by the SEC.お知らせ • Mar 28Acura Pharmaceuticals, Inc. announced delayed annual 10-K filingOn 03/27/2026, Acura Pharmaceuticals, Inc. announced that they will be unable to file their next 10-K by the deadline required by the SEC.お知らせ • Mar 11Acura Pharmaceuticals, Inc. announced that it has received $0.1 million in fundingAcura Pharmaceuticals, Inc. announced a private placement of loan for a principal amount of $100,000 on March 10, 2026. The transaction included participation from returning lender, Abuse Deterrent Pharma, LLC. The company issued a secured promissory note. The note bears interest at 5.25%. The Events of default under the Note include, among other items, bankruptcy events, failure to pay interest and principal when due and such failure continues for 5 days, and if Acura is generally not, or is unable to, or admits in writing its inability to, pay its debts as those debts become due. If any amount payable hereunder is not paid when due (without regard to any applicable grace periods), whether at stated maturity, by acceleration, or otherwise, including upon an event of default, such overdue amount shall bear interest at the rate per annum of 7.5% from the date of such non-payment until such amount is paid in full. The company has received a total principal balance of $9,894,279.お知らせ • Nov 23Acura Pharmaceuticals, Inc. announced delayed 10-Q filingOn 11/21/2025, Acura Pharmaceuticals, Inc. announced that they will be unable to file their next 10-Q by the deadline required by the SEC.お知らせ • Sep 04Acura Pharmaceuticals, Inc. announced that it has received $8.694279 million in funding from Abuse Deterrent Pharma, LLCAcura Pharmaceuticals, Inc. announced a private placement of loan for a principal amount of $100,000 on September 3, 2025. The transaction included participation from returning lender, Abuse Deterrent Pharma, LLC. The company issued a secured promissory note. The note bears interest at 5.25%. The Events of default under the Note include, among other items, bankruptcy events, failure to pay interest and principal when due and such failure continues for 5 days, and if Acura is generally not, or is unable to, or admits in writing its inability to, pay its debts as those debts become due. If any amount payable hereunder is not paid when due (without regard to any applicable grace periods), whether at stated maturity, by acceleration, or otherwise, including upon an event of default, such overdue amount shall bear interest at the rate per annum of 7.5% from the date of such non-payment until such amount is paid in full. The company has received a total principal balance of $8,694,279.お知らせ • Aug 20Acura Pharmaceuticals, Inc. announced delayed 10-Q filingOn 08/19/2025, Acura Pharmaceuticals, Inc. announced that they will be unable to file their next 10-Q by the deadline required by the SEC.最新情報をもっと見るRecent updatesお知らせ • May 14Acura Pharmaceuticals, Inc. announced delayed 10-Q filingOn 05/13/2026, Acura Pharmaceuticals, Inc. announced that they will be unable to file their next 10-Q by the deadline required by the SEC.お知らせ • Mar 28Acura Pharmaceuticals, Inc. announced delayed annual 10-K filingOn 03/27/2026, Acura Pharmaceuticals, Inc. announced that they will be unable to file their next 10-K by the deadline required by the SEC.お知らせ • Mar 11Acura Pharmaceuticals, Inc. announced that it has received $0.1 million in fundingAcura Pharmaceuticals, Inc. announced a private placement of loan for a principal amount of $100,000 on March 10, 2026. The transaction included participation from returning lender, Abuse Deterrent Pharma, LLC. The company issued a secured promissory note. The note bears interest at 5.25%. The Events of default under the Note include, among other items, bankruptcy events, failure to pay interest and principal when due and such failure continues for 5 days, and if Acura is generally not, or is unable to, or admits in writing its inability to, pay its debts as those debts become due. If any amount payable hereunder is not paid when due (without regard to any applicable grace periods), whether at stated maturity, by acceleration, or otherwise, including upon an event of default, such overdue amount shall bear interest at the rate per annum of 7.5% from the date of such non-payment until such amount is paid in full. The company has received a total principal balance of $9,894,279.お知らせ • Nov 23Acura Pharmaceuticals, Inc. announced delayed 10-Q filingOn 11/21/2025, Acura Pharmaceuticals, Inc. announced that they will be unable to file their next 10-Q by the deadline required by the SEC.お知らせ • Sep 04Acura Pharmaceuticals, Inc. announced that it has received $8.694279 million in funding from Abuse Deterrent Pharma, LLCAcura Pharmaceuticals, Inc. announced a private placement of loan for a principal amount of $100,000 on September 3, 2025. The transaction included participation from returning lender, Abuse Deterrent Pharma, LLC. The company issued a secured promissory note. The note bears interest at 5.25%. The Events of default under the Note include, among other items, bankruptcy events, failure to pay interest and principal when due and such failure continues for 5 days, and if Acura is generally not, or is unable to, or admits in writing its inability to, pay its debts as those debts become due. If any amount payable hereunder is not paid when due (without regard to any applicable grace periods), whether at stated maturity, by acceleration, or otherwise, including upon an event of default, such overdue amount shall bear interest at the rate per annum of 7.5% from the date of such non-payment until such amount is paid in full. The company has received a total principal balance of $8,694,279.お知らせ • Aug 20Acura Pharmaceuticals, Inc. announced delayed 10-Q filingOn 08/19/2025, Acura Pharmaceuticals, Inc. announced that they will be unable to file their next 10-Q by the deadline required by the SEC.お知らせ • May 23Acura Pharmaceuticals, Inc. and Abuse Deterrent Pharma, LLC Announces Second Meeting with US Food and Drug AdministrationAcura Pharmaceuticals, Inc. reported that on May 15, 2025 the Company and its development partner, AbuseDeterrent Pharma, LLC, had a second meeting with the US Food and Drug Administration (FDA) regarding further development requirements for its drug candidate LTX-03 (hydrocodone bitartrate and acetaminophen) tablets to progress toward a New Drug Application (NDA) submission. LTX-03 uses Acura's LIMITx technology that is designed to provide incrementally lower, non-linear peak drug blood concentrations (Cmax) of hydrocodone as additional tablets are ingested. Subject to the final FDA meeting minutes and further deliberations and analyses by the Companies, expect to conduct one additional human pharmacokinetic study of a single tablet dose of LTX-03 compared to a single FDA Reference Standard drug in the fed and fasted state. This study, designated AP-LTX-310, will commence following production of new clinical supplies of LTX-03. Subject to NDA review, FDA was amenable to describing the unique pharmacokinetic characteristics of LTX-03 in the final approved labeling. FDA advised that a label claim suggesting a lower risk of overdose would not be warranted by pharmacokinetic testing alone. The Company believes a study to support a lower risk safety claim would best be accomplished post-NDA approval, which cannot be assured. FDA indicated the lower 5/325mg and 7.5/325mg dosage strengths of LTX-03 will require a plan to scientifically support those products in the NDA. The company is evaluating whether to conduct such a study for the NDA submission or to study and add these strengths after NDA approval, which cannot be assurance. LTX-03 (hydocodone with acetaminophen) The incidence and severity of side effects, such as nausea, vomiting and respiratory depression, associated with opioid pain relievers, such as hydrocodone, increase with increased blood plasma concentration of the opioid. Such forward-looking statements involve known and unknown risks, uncertainties and other factors which may cause the actual results, performance, or achievements expressed or implied by such forward-looking statements.お知らせ • May 15Acura Pharmaceuticals, Inc. announced delayed 10-Q filingOn 05/14/2025, Acura Pharmaceuticals, Inc. announced that they will be unable to file their next 10-Q by the deadline required by the SEC.お知らせ • Mar 27Acura Pharmaceuticals, Inc. announced delayed annual 10-K filingOn 03/26/2025, Acura Pharmaceuticals, Inc. announced that they will be unable to file their next 10-K by the deadline required by the SEC.お知らせ • Nov 22Acura Pharmaceuticals, Inc. announced delayed 10-Q filingOn 11/21/2024, Acura Pharmaceuticals, Inc. announced that they will be unable to file their next 10-Q by the deadline required by the SEC.お知らせ • Aug 10Acura Pharmaceuticals, Inc. announced delayed 10-Q filingOn 08/09/2024, Acura Pharmaceuticals, Inc. announced that they will be unable to file their next 10-Q by the deadline required by the SEC.お知らせ • May 17Acura Pharmaceuticals, Inc. announced delayed 10-Q filingOn 05/15/2024, Acura Pharmaceuticals, Inc. announced that they will be unable to file their next 10-Q by the deadline required by the SEC.お知らせ • Apr 02Acura Pharmaceuticals, Inc. announced delayed annual 10-K filingOn 04/01/2024, Acura Pharmaceuticals, Inc. announced that they will be unable to file their next 10-K by the deadline required by the SEC.お知らせ • Feb 15Acura Pharmaceuticals, Inc. announced that it has received $0.25 million in fundingAcura Pharmaceuticals, Inc. announced a private placement of loan for gross processed of $250,000 on February 14, 2024. The transaction included participation from returning lender Abuse Deterrent Pharma, LLC. The company issued an unsecured promissory note. The note bears interest at 5.25%, and matures on March 31, 2024, at which time all principal and interest is due. Events of default under the note include, among other items, bankruptcy events, failure to pay interest and principal when due and such failure continues for 5 days, and if company is generally not, or is unable to, or admits in writing its inability to, pay its debts as they become due. If any amount payable hereunder is not paid when due (without regard to any applicable grace periods), whether at stated maturity, by acceleration, or otherwise, including upon an event of default, such overdue amount shall bear interest at the rate per annum of 7.5% from the date of such non-payment until such amount is paid in full. the company received a total of $5,169,279.お知らせ • Nov 04Acura Pharmaceuticals, Inc. announced delayed 10-Q filingOn 11/03/2023, Acura Pharmaceuticals, Inc. announced that they will be unable to file their next 10-Q by the deadline required by the SEC.お知らせ • Sep 26Acura Pharmaceuticals, Inc. Announces Retirement and Resignation of Mr. Bruce F. (Toby) Wesson as Member of Board of DirectorsEffective September 22, 2023, Mr. Bruce F. (Toby) Wesson retired and resigned as a member of Board of Directors and the Board of Directors of Acura Pharmaceutical Technologies, Inc. subsidiary. Mr. Wesson has agreed to serve as Director Emeritus following his resignation. In such capacity, Mr. Wesson may attend Board and Committee meetings and participate in the discussion of matters at such meetings, but he will not have voting rights on any such matters. Mr. Wesson has been a member of Board of Directors since March 1998. From January 1991 until June 30, 2011, Mr. Wesson was a Partner of Galen Associates, a health care venture firm, and a General Partner of Galen Partners III, L.P. Prior to January 1991, he was Senior Vice President and Managing Director of Smith Barney, Harris Upham & Co. Inc., an investment banking firm. From May 2006 until June 2016 he served on the Board of Derma Sciences, Inc. From June 1999 until January 2016 he served as director of the Board of MedAssets, Inc. and for over eight years until January 2016 served as Vice Chairman of MedAssets, Inc. Mr. Wesson earned a Bachelor of Arts degree from Colgate University and a Masters of Business Administration from Columbia University. As a member of Acura's Board, Mr. Wesson helped to oversee the transformation of Acura from a troubled generic pharmaceutical manufacturer to an innovative specialty pharmaceutical company.お知らせ • Sep 02Acura Pharmaceuticals, Inc. Provides Update Related to LTX-03 (Hydrocodone Bitartrate and Acetaminophen) TabletsAcura Pharmaceuticals, Inc. reported that the LTX-03 (hydrocodone bitartrate and acetaminophen) tablets using Acura’s LIMITx technology manufactured in the three New Drug Application (NDA) required registration batches passed testing at the twenty-four month time point in an ongoing shelf life study when stored at normal temperature and humidity conditions, also known as controlled room temperature. The patented LIMITx technology is a composition of inactive ingredients formulated in a manner that reduces the risks of drug overdose by reducing peak drug levels when excessive numbers of tablets are ingested. Two known hydrocodone derivatives continues to be detected in the CRT samples, as well as, unknown impurities. The unknown impurities remain at levels within standards typically accepted by the Food and Drug Administration (FDA) for such impurities but the levels have increased since the eighteen month analysis. They intend to continue the shelf life study with the CRT samples as previously planned. The LTX-03 tablets were produced at the commercial contract manufacturer, in the to-be-marketed formulation, at commercial (equipment and process) scale. The data being generated in the shelf life study is intended to be used to support the manufacturing and shelf life requirements for a NDA. FDA Guidance allows for the use of a minimum of 24 month CRT data to establish shelf life standards for a product. Recent reports suggest growing numbers of legitimate pain patients are going undertreated as they can no longer find doctors willing to treat them due to new prescribing guidelines associated with the opioid epidemic. Suicide is increasingly seen as the only remedy for some of these patients through opioid overdose. They goal with LIMITx is to develop a treatment for effective pain relief at a one or two tablet dose while providing overdose protection by limiting high peak levels of drug in the bloodstream (Cmax) that can lead to respiratory depression and death when more than the recommended dose is ingested. LIMITx works by neutralizing stomach acid with buffering ingredients as increasing numbers of tablets are swallowed thereby reducing the stomach acid available to cause the release and subsequent systemic absorption of the active ingredient from micro-particles contained in the LIMITx tablets. In a human clinical study, formulations of LTX-03 demonstrated, under fasted conditions, analgesic levels of hydrocodone in the blood when taken at a recommended one or two tablet dose but reduced the maximum blood level (Cmax) up to 30% when subjects were exposed to higher buffer ingredient levels. Hydrocodone with acetaminophen remains the single largest prescribed opioid in the U.S. with excess oral ingestion as the most prevalent method of misuse. Analysis of forensic data associated with hydrocodone overdose death suggests a typical consumption of approximately 16 immediate-release tablets, well within the number of tablets in an average filled opioid prescription. The Company intends to demonstrate that a meaningful reduction in Cmax associated with oral overdose can mitigate the risk of respiratory depression and death. LTX-03 may offer safety advantages over existing opioid therapies consistent with the FDA’s recently proposed new guidelines for the approval of opioid products.お知らせ • Aug 11Acura Pharmaceuticals, Inc. announced delayed 10-Q filingOn 08/10/2023, Acura Pharmaceuticals, Inc. announced that they will be unable to file their next 10-Q by the deadline required by the SEC.お知らせ • May 16Acura Pharmaceuticals, Inc. announced delayed 10-Q filingOn 05/15/2023, Acura Pharmaceuticals, Inc. announced that they will be unable to file their next 10-Q by the deadline required by the SEC.お知らせ • Feb 03Acura Pharmaceuticals, Inc. Announces First Clinical Study for Its Investigational Drug LTX-03Acura Pharmaceuticals, Inc. announced that the first clinical study for its investigational drug LTX-03 (hydrocodone bitartrate and acetaminophen) tablets using the company’s LIMITx technology commenced enrollment. The study, AP-LTX-311 or Study 311, is designed to evaluate the levels of hydrocodone and acetaminophen in the blood plasma when taken at doses in excess of normal therapeutic doses. The LIMITx technology is designed to minimize risks associated with overdose by lowering the maximum drug concentration of hydrocodone in the blood as increasing numbers of tablets are ingested. The Company expects topline results from Study 311 to be available in the second quarter of 2023. Study 311 is a phase 1 pharmacokinetic study in fasted healthy adult subjects who will be taking 2, 5 and 9 tablet doses. Study 311 is targeted to have 20 subjects complete all doses which will be administered in crossover fashion over a 4 week dosing period, with one week washout between doses. All subjects will receive an intravenous naloxone blockade during drug administration to negate the pharmacologic effects of the opioid hydrocodone. The Company expects to compare the results from the LTX-03 doses to the known, well-characterized pharmacokinetic results for hydrocodone and acetaminophen from the published literature with the intent to demonstrate lower levels of hydrocodone exposure for LTX-03 compared to the currently marketed comparator product as increasing number of tablets are ingested. The acetaminophen active ingredient is not incorporated into the LIMITx technology in the LTX-03 tablet and is not expected to be substantially different from the comparator product.お知らせ • Nov 05Acura Pharmaceuticals, Inc. announced delayed 10-Q filingOn 11/04/2022, Acura Pharmaceuticals, Inc. announced that they will be unable to file their next 10-Q by the deadline required by the SEC.お知らせ • Jul 20Acura Pharmaceuticals, Inc. announced that it has received $0.15 million in fundingAcura Pharmaceuticals, Inc. announced a private placement of loan for gross processed of $150,000 on July 18, 2022. The transaction included participation from existing investor John Schutte. The company issued an unsecured promissory note. The note bears interest at 5.25%, and matures on December 31, 2023, at which time all principal and interest is due. Events of default under the note include, among other items, bankruptcy events, failure to pay interest and principal when due and such failure continues for 5 days, and if Acura is generally not, or is unable to, or admits in writing its inability to, pay its debts as they become due. If any amount payable hereunder is not paid when due (without regard to any applicable grace periods), whether at stated maturity, by acceleration, or otherwise, including upon an event of default, such overdue amount shall bear interest at the rate per annum of 7.5% from the date of such non-payment until such amount is paid in full. The company received a total of $1,275,000 to date.お知らせ • May 17Acura Pharmaceuticals, Inc. announced delayed 10-Q filingOn 05/16/2022, Acura Pharmaceuticals, Inc. announced that they will be unable to file their next 10-Q by the deadline required by the SEC.お知らせ • Apr 01Acura Pharmaceuticals, Inc. announced delayed annual 10-K filingOn 03/31/2022, Acura Pharmaceuticals, Inc. announced that they will be unable to file their next 10-K by the deadline required by the SEC.お知らせ • Mar 03Acura Pharmaceuticals and AD Pharma Amend License to LIMITx™ LTX-03Acura Pharmaceuticals, Inc. announced an amendment to its License, Development and Commercialization Agreement (“Agreement”) regarding Acura’s LIMITx™ LTX-03 product candidate with Abuse Deterrent Pharmaceuticals, LLC (“AD Pharma”) to extend the FDA Acceptance Date for LTX-03 (“NDA Acceptance Date”) to December 31, 2022. The Company expects to complete clinical studies and other required steps to file the NDA and gain regulatory acceptance by that date. Recent reports suggest growing numbers of legitimate pain patients are going undertreated as they can no longer find doctors willing to treat them due to new prescribing guidelines associated with the opioid epidemic. Suicide is increasingly seen as the only remedy for some of these patients through opioid overdose. Goal with LIMITx is to develop a treatment for effective pain relief at a one or two tablet dose while providing overdose protection by limiting high peak levels of drug in the bloodstream (Cmax) that can lead to respiratory depression and death when more than the recommended dose is ingested. LIMITx works by neutralizing stomach acid with buffering ingredients as increasing numbers of tablets are swallowed thereby reducing the stomach acid available to cause the release and subsequent systemic absorption of the active ingredient from micro-particles contained in the LIMITx tablets. In a human clinical study, formulations of LTX-03 demonstrated, under fasted conditions, analgesic levels of hydrocodone in the blood when taken at a recommended one or two tablet dose but reduced the maximum blood level (Cmax) up to 34% when subjects were exposed to higher buffer ingredient levels. Hydrocodone with acetaminophen remains the single largest prescribed opioid in the U.S. with excess oral ingestion as the most prevalent method of misuse. Clinical studies with hydromorphone (LTX-04) demonstrated reductions in Cmax of up to 65% when up to 8 tablets were ingested. Analysis of forensic data associated with hydrocodone overdose death suggests a typical consumption of approximately 16 immediate-release tablets, well within the number of tablets in an average filled opioid prescription. The Company intends to demonstrate that a meaningful reduction in Cmax associated with oral overdose can mitigate the risk of respiratory depression and death. LTX-03 may offer safety advantages over existing opioid therapies consistent with the Food and Drug Administration’s (FDA) recently proposed new guidelines for the approval of opioid products.お知らせ • Feb 15Acura Pharmaceuticals Provides Development Update on LTX-03Acura Pharmaceuticals, Inc. announced that the LTX-03 (hydrocodone bitartrate and acetaminophen) tablets using Acura’s LIMITx technology manufactured in the three New Drug Application (“NDA”) required registration batches successfully passed testing at the six month time point in an ongoing shelf life study when stored at normal temperature and humidity conditions, also known as controlled room temperature (“CRT”). The patented LIMITx technology is a composition of inactive ingredients formulated in a manner that reduces the risks of drug overdose by reducing peak drug levels when inappropriate numbers of tablets are ingested. When stored at high temperature and humidity, also known as accelerated conditions (“AC”), the six month tests revealed the presence of a known derivative of hydrocodone at levels requiring further testing. This known derivative was also detected in the CRT samples and intermediate condition (“IC”) samples, those stored at temperatures and humidity between CRT and AC, at levels within normally accepted limits at this stage of development. The company intends to continue the shelf life study with the CRT and IC samples as previously planned. The LTX-03 tablets were produced at the commercial contract manufacturer, in the to-be-marketed formulation, at commercial (equipment and process) scale. The data being generated in the shelf life study is intended to be used to support the manufacturing and shelf life requirements for an NDA. Acura has completed its review of the Advice Letter received in October 2021 from the Food and Drug Administration (“FDA”) regarding proposed clinical study program for LTX-03. The company updated the three pharmacokinetic study protocols submitted to the FDA and drafted a fourth pharmacokinetic study protocol based on the Advice Letter. These protocols have been provided to development and commercialization partner, Abuse Deterrent Pharmaceuticals, LLC (“AD Pharma”) for comment and determination of the timing of initiation of the studies. The new protocols will require submission to the FDA under the LTX-03 Investigational New Drug (“IND”) application before they can commence.お知らせ • Jun 08Acura Pharmaceuticals Provides Development Update on LTX-03Acura Pharmaceuticals, Inc. announced the successful completion of three NDA required registration batches of the to-be-marketed LTX-03 formulation. The LTX-03 tablets were manufactured on commercial scale equipment and passed all requisite quality assurance tests. The LTX-03 tablets from these batches will be used in a six month shelf life stability study, which will commence immediately, and in human clinical studies, which will commence after an update to the Investigation New Drug application on file with the Food and Drug Administration (FDA). LTX-03 (hydrocodone with acetaminophen): Recent reports suggest growing numbers of legitimate pain patients are going undertreated as they can no longer find doctors willing to treat them due to new prescribing guidelines associated with the opioid epidemic. Suicide is increasingly seen as the only remedy for some of these patients through opioid overdose. The company's goal with LIMITx is to develop a treatment for effective pain relief at a one or two tablet dose while providing overdose protection by limiting high peak levels of drug in the bloodstream (Cmax) that can lead to respiratory depression and death when more than the recommended dose is ingested. LIMITx works by neutralizing stomach acid with buffering ingredients as increasing numbers of tablets are swallowed thereby reducing the stomach acid available to cause the release and subsequent systemic absorption of the active ingredient from micro-particles contained in the LIMITx tablets. In a human clinical study, formulations of LTX-03 demonstrated, under fasted conditions, analgesic levels of hydrocodone in the blood when taken at a recommended one or two tablet dose but reduced the maximum blood level (Cmax) up to 34% when subjects were exposed to higher buffer ingredient levels. Hydrocodone with acetaminophen remains the single largest prescribed opioid in the U.S. with excess oral ingestion as the most prevalent method of misuse. Clinical studies with hydromorphone (LTX-04) demonstrated reductions in Cmax of up to 65% when up to 8 tablets were ingested. Analysis of forensic data associated with hydrocodone overdose death suggests a typical consumption of approximately 16 immediate-release tablets, well within the number of tablets in an average filled opioid prescription. The Company intends to demonstrate that a meaningful reduction in Cmax associated with oral overdose can mitigate the risk of respiratory depression and death. LTX-03 may offer safety advantages over existing opioid therapies consistent with the Food and Drug Administration’s (FDA) recently proposed new guidelines for the approval of opioid products.株主還元ACURUS PharmaceuticalsUS 市場7D0%5.3%1.1%1Yn/a44.3%28.7%株主還元を見る業界別リターン: ACURがUS Pharmaceuticals業界に対してどのようなパフォーマンスを示したかを判断するにはデータが不十分です。リターン対市場: ACUR US市場に対してどのようなパフォーマンスを示したかを判断するにはデータが不十分です。価格変動Is ACUR's price volatile compared to industry and market?ACUR volatilityACUR Average Weekly Movementn/aPharmaceuticals Industry Average Movement9.9%Market Average Movement7.2%10% most volatile stocks in US Market16.4%10% least volatile stocks in US Market3.1%安定した株価: ACURの株価は、 US市場と比較して過去 3 か月間で変動しています。時間の経過による変動: 過去 1 年間のACURのボラティリティの変化を判断するには データが不十分です。会社概要設立従業員CEO（最高経営責任者ウェブサイト1935n/aBob Joneswww.acurapharm.comアキュラ・ファーマシューティカルズ・インクは、革新的なドラッグデリバリー企業として、米国における医薬品の安全な使用に対応する技術や製品の研究、開発、商業化に取り組んでいる。同社は、急性および慢性の中等度から重度の疼痛管理を適応とするスケジュールII麻薬であるオキセイド錠剤や、様々な非処方および処方箋の風邪薬、副鼻腔薬、アレルギー薬の鼻腔充血除去薬として使用されるプソイドエフェドリンとアセトアミノフェンの錠剤であるネクサフェド製品を提供している。アキュラ・ファーマシューティカルズ・インクは、Egalet US, Inc.およびEgalet Ltd.と、オキセイド製品の世界的な製造・商業化に関する提携およびライセンス契約を結んでおり、Abuse Deterrent Pharma, LLCとは、LIMITx技術を利用した即時放出錠剤LTX-03の開発および商業化契約を結んでいる。同社の前身はHalsey Drug Co.同社は1935年に法人化され、イリノイ州パラティンを拠点としている。アキュラ・ファーマシューティカルズ社は、Abuse Deterrent Pharma, LLCの子会社として運営されている。もっと見るAcura Pharmaceuticals, Inc. 基礎のまとめAcura Pharmaceuticals の収益と売上を時価総額と比較するとどうか。ACUR 基礎統計学時価総額US$13.33k収益（TTM）-US$879.00k売上高(TTM)US$1.56m0.0xP/Sレシオ0.0xPER（株価収益率ACUR は割高か？公正価値と評価分析を参照収益と収入最新の決算報告書（TTM）に基づく主な収益性統計ACUR 損益計算書（TTM）収益US$1.56m売上原価US$1.52m売上総利益US$39.00kその他の費用US$918.00k収益-US$879.00k直近の収益報告Dec 31, 2021次回決算日該当なし一株当たり利益（EPS）0グロス・マージン0.00%純利益率0.00%有利子負債／自己資本比率0.0%ACUR の長期的なパフォーマンスは？過去の実績と比較を見るView Valuation企業分析と財務データの現状データ最終更新日（UTC時間）企業分析2026/05/24 12:25終値2026/05/14 00:00収益2021/12/31年間収益2021/12/31データソース企業分析に使用したデータはS&P Global Market Intelligence LLC のものです。本レポートを作成するための分析モデルでは、以下のデータを使用しています。データは正規化されているため、ソースが利用可能になるまでに時間がかかる場合があります。パッケージデータタイムフレーム米国ソース例会社財務10年損益計算書キャッシュ・フロー計算書貸借対照表SECフォーム10-KSECフォーム10-Qアナリストのコンセンサス予想+プラス3年予想財務アナリストの目標株価アナリストリサーチレポートBlue Matrix市場価格30年株価配当、分割、措置ICEマーケットデータSECフォームS-1所有権10年トップ株主インサイダー取引SECフォーム4SECフォーム13Dマネジメント10年リーダーシップ・チーム取締役会SECフォーム10-KSECフォームDEF 14A主な進展10年会社からのお知らせSECフォーム8-K* 米国証券を対象とした例であり、非米国証券については、同等の規制書式および情報源を使用。特に断りのない限り、すべての財務データは1年ごとの期間に基づいていますが、四半期ごとに更新されます。これは、TTM（Trailing Twelve Month）またはLTM（Last Twelve Month）データとして知られています。詳細はこちら。分析モデルとスノーフレーク本レポートを生成するために使用した分析モデルの詳細は当社のGithubページでご覧いただけます。また、レポートの使用方法に関するガイドやYoutubeのチュートリアルも掲載しています。シンプリー・ウォールストリート分析モデルを設計・構築した世界トップクラスのチームについてご紹介します。業界およびセクターの指標私たちの業界とセクションの指標は、Simply Wall Stによって6時間ごとに計算されます。アナリスト筋Acura Pharmaceuticals, Inc. 0 これらのアナリストのうち、弊社レポートのインプットとして使用した売上高または利益の予想を提出したのは、 。アナリストの投稿は一日中更新されます。1 アナリスト機関Robert HazlettRoth Capital Partners
お知らせ • May 14Acura Pharmaceuticals, Inc. announced delayed 10-Q filingOn 05/13/2026, Acura Pharmaceuticals, Inc. announced that they will be unable to file their next 10-Q by the deadline required by the SEC.
お知らせ • Mar 28Acura Pharmaceuticals, Inc. announced delayed annual 10-K filingOn 03/27/2026, Acura Pharmaceuticals, Inc. announced that they will be unable to file their next 10-K by the deadline required by the SEC.
お知らせ • Mar 11Acura Pharmaceuticals, Inc. announced that it has received $0.1 million in fundingAcura Pharmaceuticals, Inc. announced a private placement of loan for a principal amount of $100,000 on March 10, 2026. The transaction included participation from returning lender, Abuse Deterrent Pharma, LLC. The company issued a secured promissory note. The note bears interest at 5.25%. The Events of default under the Note include, among other items, bankruptcy events, failure to pay interest and principal when due and such failure continues for 5 days, and if Acura is generally not, or is unable to, or admits in writing its inability to, pay its debts as those debts become due. If any amount payable hereunder is not paid when due (without regard to any applicable grace periods), whether at stated maturity, by acceleration, or otherwise, including upon an event of default, such overdue amount shall bear interest at the rate per annum of 7.5% from the date of such non-payment until such amount is paid in full. The company has received a total principal balance of $9,894,279.
お知らせ • Nov 23Acura Pharmaceuticals, Inc. announced delayed 10-Q filingOn 11/21/2025, Acura Pharmaceuticals, Inc. announced that they will be unable to file their next 10-Q by the deadline required by the SEC.
お知らせ • Sep 04Acura Pharmaceuticals, Inc. announced that it has received $8.694279 million in funding from Abuse Deterrent Pharma, LLCAcura Pharmaceuticals, Inc. announced a private placement of loan for a principal amount of $100,000 on September 3, 2025. The transaction included participation from returning lender, Abuse Deterrent Pharma, LLC. The company issued a secured promissory note. The note bears interest at 5.25%. The Events of default under the Note include, among other items, bankruptcy events, failure to pay interest and principal when due and such failure continues for 5 days, and if Acura is generally not, or is unable to, or admits in writing its inability to, pay its debts as those debts become due. If any amount payable hereunder is not paid when due (without regard to any applicable grace periods), whether at stated maturity, by acceleration, or otherwise, including upon an event of default, such overdue amount shall bear interest at the rate per annum of 7.5% from the date of such non-payment until such amount is paid in full. The company has received a total principal balance of $8,694,279.
お知らせ • Aug 20Acura Pharmaceuticals, Inc. announced delayed 10-Q filingOn 08/19/2025, Acura Pharmaceuticals, Inc. announced that they will be unable to file their next 10-Q by the deadline required by the SEC.
お知らせ • May 14Acura Pharmaceuticals, Inc. announced delayed 10-Q filingOn 05/13/2026, Acura Pharmaceuticals, Inc. announced that they will be unable to file their next 10-Q by the deadline required by the SEC.
お知らせ • Mar 28Acura Pharmaceuticals, Inc. announced delayed annual 10-K filingOn 03/27/2026, Acura Pharmaceuticals, Inc. announced that they will be unable to file their next 10-K by the deadline required by the SEC.
お知らせ • Mar 11Acura Pharmaceuticals, Inc. announced that it has received $0.1 million in fundingAcura Pharmaceuticals, Inc. announced a private placement of loan for a principal amount of $100,000 on March 10, 2026. The transaction included participation from returning lender, Abuse Deterrent Pharma, LLC. The company issued a secured promissory note. The note bears interest at 5.25%. The Events of default under the Note include, among other items, bankruptcy events, failure to pay interest and principal when due and such failure continues for 5 days, and if Acura is generally not, or is unable to, or admits in writing its inability to, pay its debts as those debts become due. If any amount payable hereunder is not paid when due (without regard to any applicable grace periods), whether at stated maturity, by acceleration, or otherwise, including upon an event of default, such overdue amount shall bear interest at the rate per annum of 7.5% from the date of such non-payment until such amount is paid in full. The company has received a total principal balance of $9,894,279.
お知らせ • Nov 23Acura Pharmaceuticals, Inc. announced delayed 10-Q filingOn 11/21/2025, Acura Pharmaceuticals, Inc. announced that they will be unable to file their next 10-Q by the deadline required by the SEC.
お知らせ • Sep 04Acura Pharmaceuticals, Inc. announced that it has received $8.694279 million in funding from Abuse Deterrent Pharma, LLCAcura Pharmaceuticals, Inc. announced a private placement of loan for a principal amount of $100,000 on September 3, 2025. The transaction included participation from returning lender, Abuse Deterrent Pharma, LLC. The company issued a secured promissory note. The note bears interest at 5.25%. The Events of default under the Note include, among other items, bankruptcy events, failure to pay interest and principal when due and such failure continues for 5 days, and if Acura is generally not, or is unable to, or admits in writing its inability to, pay its debts as those debts become due. If any amount payable hereunder is not paid when due (without regard to any applicable grace periods), whether at stated maturity, by acceleration, or otherwise, including upon an event of default, such overdue amount shall bear interest at the rate per annum of 7.5% from the date of such non-payment until such amount is paid in full. The company has received a total principal balance of $8,694,279.
お知らせ • Aug 20Acura Pharmaceuticals, Inc. announced delayed 10-Q filingOn 08/19/2025, Acura Pharmaceuticals, Inc. announced that they will be unable to file their next 10-Q by the deadline required by the SEC.
お知らせ • May 23Acura Pharmaceuticals, Inc. and Abuse Deterrent Pharma, LLC Announces Second Meeting with US Food and Drug AdministrationAcura Pharmaceuticals, Inc. reported that on May 15, 2025 the Company and its development partner, AbuseDeterrent Pharma, LLC, had a second meeting with the US Food and Drug Administration (FDA) regarding further development requirements for its drug candidate LTX-03 (hydrocodone bitartrate and acetaminophen) tablets to progress toward a New Drug Application (NDA) submission. LTX-03 uses Acura's LIMITx technology that is designed to provide incrementally lower, non-linear peak drug blood concentrations (Cmax) of hydrocodone as additional tablets are ingested. Subject to the final FDA meeting minutes and further deliberations and analyses by the Companies, expect to conduct one additional human pharmacokinetic study of a single tablet dose of LTX-03 compared to a single FDA Reference Standard drug in the fed and fasted state. This study, designated AP-LTX-310, will commence following production of new clinical supplies of LTX-03. Subject to NDA review, FDA was amenable to describing the unique pharmacokinetic characteristics of LTX-03 in the final approved labeling. FDA advised that a label claim suggesting a lower risk of overdose would not be warranted by pharmacokinetic testing alone. The Company believes a study to support a lower risk safety claim would best be accomplished post-NDA approval, which cannot be assured. FDA indicated the lower 5/325mg and 7.5/325mg dosage strengths of LTX-03 will require a plan to scientifically support those products in the NDA. The company is evaluating whether to conduct such a study for the NDA submission or to study and add these strengths after NDA approval, which cannot be assurance. LTX-03 (hydocodone with acetaminophen) The incidence and severity of side effects, such as nausea, vomiting and respiratory depression, associated with opioid pain relievers, such as hydrocodone, increase with increased blood plasma concentration of the opioid. Such forward-looking statements involve known and unknown risks, uncertainties and other factors which may cause the actual results, performance, or achievements expressed or implied by such forward-looking statements.
お知らせ • May 15Acura Pharmaceuticals, Inc. announced delayed 10-Q filingOn 05/14/2025, Acura Pharmaceuticals, Inc. announced that they will be unable to file their next 10-Q by the deadline required by the SEC.
お知らせ • Mar 27Acura Pharmaceuticals, Inc. announced delayed annual 10-K filingOn 03/26/2025, Acura Pharmaceuticals, Inc. announced that they will be unable to file their next 10-K by the deadline required by the SEC.
お知らせ • Nov 22Acura Pharmaceuticals, Inc. announced delayed 10-Q filingOn 11/21/2024, Acura Pharmaceuticals, Inc. announced that they will be unable to file their next 10-Q by the deadline required by the SEC.
お知らせ • Aug 10Acura Pharmaceuticals, Inc. announced delayed 10-Q filingOn 08/09/2024, Acura Pharmaceuticals, Inc. announced that they will be unable to file their next 10-Q by the deadline required by the SEC.
お知らせ • May 17Acura Pharmaceuticals, Inc. announced delayed 10-Q filingOn 05/15/2024, Acura Pharmaceuticals, Inc. announced that they will be unable to file their next 10-Q by the deadline required by the SEC.
お知らせ • Apr 02Acura Pharmaceuticals, Inc. announced delayed annual 10-K filingOn 04/01/2024, Acura Pharmaceuticals, Inc. announced that they will be unable to file their next 10-K by the deadline required by the SEC.
お知らせ • Feb 15Acura Pharmaceuticals, Inc. announced that it has received $0.25 million in fundingAcura Pharmaceuticals, Inc. announced a private placement of loan for gross processed of $250,000 on February 14, 2024. The transaction included participation from returning lender Abuse Deterrent Pharma, LLC. The company issued an unsecured promissory note. The note bears interest at 5.25%, and matures on March 31, 2024, at which time all principal and interest is due. Events of default under the note include, among other items, bankruptcy events, failure to pay interest and principal when due and such failure continues for 5 days, and if company is generally not, or is unable to, or admits in writing its inability to, pay its debts as they become due. If any amount payable hereunder is not paid when due (without regard to any applicable grace periods), whether at stated maturity, by acceleration, or otherwise, including upon an event of default, such overdue amount shall bear interest at the rate per annum of 7.5% from the date of such non-payment until such amount is paid in full. the company received a total of $5,169,279.
お知らせ • Nov 04Acura Pharmaceuticals, Inc. announced delayed 10-Q filingOn 11/03/2023, Acura Pharmaceuticals, Inc. announced that they will be unable to file their next 10-Q by the deadline required by the SEC.
お知らせ • Sep 26Acura Pharmaceuticals, Inc. Announces Retirement and Resignation of Mr. Bruce F. (Toby) Wesson as Member of Board of DirectorsEffective September 22, 2023, Mr. Bruce F. (Toby) Wesson retired and resigned as a member of Board of Directors and the Board of Directors of Acura Pharmaceutical Technologies, Inc. subsidiary. Mr. Wesson has agreed to serve as Director Emeritus following his resignation. In such capacity, Mr. Wesson may attend Board and Committee meetings and participate in the discussion of matters at such meetings, but he will not have voting rights on any such matters. Mr. Wesson has been a member of Board of Directors since March 1998. From January 1991 until June 30, 2011, Mr. Wesson was a Partner of Galen Associates, a health care venture firm, and a General Partner of Galen Partners III, L.P. Prior to January 1991, he was Senior Vice President and Managing Director of Smith Barney, Harris Upham & Co. Inc., an investment banking firm. From May 2006 until June 2016 he served on the Board of Derma Sciences, Inc. From June 1999 until January 2016 he served as director of the Board of MedAssets, Inc. and for over eight years until January 2016 served as Vice Chairman of MedAssets, Inc. Mr. Wesson earned a Bachelor of Arts degree from Colgate University and a Masters of Business Administration from Columbia University. As a member of Acura's Board, Mr. Wesson helped to oversee the transformation of Acura from a troubled generic pharmaceutical manufacturer to an innovative specialty pharmaceutical company.
お知らせ • Sep 02Acura Pharmaceuticals, Inc. Provides Update Related to LTX-03 (Hydrocodone Bitartrate and Acetaminophen) TabletsAcura Pharmaceuticals, Inc. reported that the LTX-03 (hydrocodone bitartrate and acetaminophen) tablets using Acura’s LIMITx technology manufactured in the three New Drug Application (NDA) required registration batches passed testing at the twenty-four month time point in an ongoing shelf life study when stored at normal temperature and humidity conditions, also known as controlled room temperature. The patented LIMITx technology is a composition of inactive ingredients formulated in a manner that reduces the risks of drug overdose by reducing peak drug levels when excessive numbers of tablets are ingested. Two known hydrocodone derivatives continues to be detected in the CRT samples, as well as, unknown impurities. The unknown impurities remain at levels within standards typically accepted by the Food and Drug Administration (FDA) for such impurities but the levels have increased since the eighteen month analysis. They intend to continue the shelf life study with the CRT samples as previously planned. The LTX-03 tablets were produced at the commercial contract manufacturer, in the to-be-marketed formulation, at commercial (equipment and process) scale. The data being generated in the shelf life study is intended to be used to support the manufacturing and shelf life requirements for a NDA. FDA Guidance allows for the use of a minimum of 24 month CRT data to establish shelf life standards for a product. Recent reports suggest growing numbers of legitimate pain patients are going undertreated as they can no longer find doctors willing to treat them due to new prescribing guidelines associated with the opioid epidemic. Suicide is increasingly seen as the only remedy for some of these patients through opioid overdose. They goal with LIMITx is to develop a treatment for effective pain relief at a one or two tablet dose while providing overdose protection by limiting high peak levels of drug in the bloodstream (Cmax) that can lead to respiratory depression and death when more than the recommended dose is ingested. LIMITx works by neutralizing stomach acid with buffering ingredients as increasing numbers of tablets are swallowed thereby reducing the stomach acid available to cause the release and subsequent systemic absorption of the active ingredient from micro-particles contained in the LIMITx tablets. In a human clinical study, formulations of LTX-03 demonstrated, under fasted conditions, analgesic levels of hydrocodone in the blood when taken at a recommended one or two tablet dose but reduced the maximum blood level (Cmax) up to 30% when subjects were exposed to higher buffer ingredient levels. Hydrocodone with acetaminophen remains the single largest prescribed opioid in the U.S. with excess oral ingestion as the most prevalent method of misuse. Analysis of forensic data associated with hydrocodone overdose death suggests a typical consumption of approximately 16 immediate-release tablets, well within the number of tablets in an average filled opioid prescription. The Company intends to demonstrate that a meaningful reduction in Cmax associated with oral overdose can mitigate the risk of respiratory depression and death. LTX-03 may offer safety advantages over existing opioid therapies consistent with the FDA’s recently proposed new guidelines for the approval of opioid products.
お知らせ • Aug 11Acura Pharmaceuticals, Inc. announced delayed 10-Q filingOn 08/10/2023, Acura Pharmaceuticals, Inc. announced that they will be unable to file their next 10-Q by the deadline required by the SEC.
お知らせ • May 16Acura Pharmaceuticals, Inc. announced delayed 10-Q filingOn 05/15/2023, Acura Pharmaceuticals, Inc. announced that they will be unable to file their next 10-Q by the deadline required by the SEC.
お知らせ • Feb 03Acura Pharmaceuticals, Inc. Announces First Clinical Study for Its Investigational Drug LTX-03Acura Pharmaceuticals, Inc. announced that the first clinical study for its investigational drug LTX-03 (hydrocodone bitartrate and acetaminophen) tablets using the company’s LIMITx technology commenced enrollment. The study, AP-LTX-311 or Study 311, is designed to evaluate the levels of hydrocodone and acetaminophen in the blood plasma when taken at doses in excess of normal therapeutic doses. The LIMITx technology is designed to minimize risks associated with overdose by lowering the maximum drug concentration of hydrocodone in the blood as increasing numbers of tablets are ingested. The Company expects topline results from Study 311 to be available in the second quarter of 2023. Study 311 is a phase 1 pharmacokinetic study in fasted healthy adult subjects who will be taking 2, 5 and 9 tablet doses. Study 311 is targeted to have 20 subjects complete all doses which will be administered in crossover fashion over a 4 week dosing period, with one week washout between doses. All subjects will receive an intravenous naloxone blockade during drug administration to negate the pharmacologic effects of the opioid hydrocodone. The Company expects to compare the results from the LTX-03 doses to the known, well-characterized pharmacokinetic results for hydrocodone and acetaminophen from the published literature with the intent to demonstrate lower levels of hydrocodone exposure for LTX-03 compared to the currently marketed comparator product as increasing number of tablets are ingested. The acetaminophen active ingredient is not incorporated into the LIMITx technology in the LTX-03 tablet and is not expected to be substantially different from the comparator product.
お知らせ • Nov 05Acura Pharmaceuticals, Inc. announced delayed 10-Q filingOn 11/04/2022, Acura Pharmaceuticals, Inc. announced that they will be unable to file their next 10-Q by the deadline required by the SEC.
お知らせ • Jul 20Acura Pharmaceuticals, Inc. announced that it has received $0.15 million in fundingAcura Pharmaceuticals, Inc. announced a private placement of loan for gross processed of $150,000 on July 18, 2022. The transaction included participation from existing investor John Schutte. The company issued an unsecured promissory note. The note bears interest at 5.25%, and matures on December 31, 2023, at which time all principal and interest is due. Events of default under the note include, among other items, bankruptcy events, failure to pay interest and principal when due and such failure continues for 5 days, and if Acura is generally not, or is unable to, or admits in writing its inability to, pay its debts as they become due. If any amount payable hereunder is not paid when due (without regard to any applicable grace periods), whether at stated maturity, by acceleration, or otherwise, including upon an event of default, such overdue amount shall bear interest at the rate per annum of 7.5% from the date of such non-payment until such amount is paid in full. The company received a total of $1,275,000 to date.
お知らせ • May 17Acura Pharmaceuticals, Inc. announced delayed 10-Q filingOn 05/16/2022, Acura Pharmaceuticals, Inc. announced that they will be unable to file their next 10-Q by the deadline required by the SEC.
お知らせ • Apr 01Acura Pharmaceuticals, Inc. announced delayed annual 10-K filingOn 03/31/2022, Acura Pharmaceuticals, Inc. announced that they will be unable to file their next 10-K by the deadline required by the SEC.
お知らせ • Mar 03Acura Pharmaceuticals and AD Pharma Amend License to LIMITx™ LTX-03Acura Pharmaceuticals, Inc. announced an amendment to its License, Development and Commercialization Agreement (“Agreement”) regarding Acura’s LIMITx™ LTX-03 product candidate with Abuse Deterrent Pharmaceuticals, LLC (“AD Pharma”) to extend the FDA Acceptance Date for LTX-03 (“NDA Acceptance Date”) to December 31, 2022. The Company expects to complete clinical studies and other required steps to file the NDA and gain regulatory acceptance by that date. Recent reports suggest growing numbers of legitimate pain patients are going undertreated as they can no longer find doctors willing to treat them due to new prescribing guidelines associated with the opioid epidemic. Suicide is increasingly seen as the only remedy for some of these patients through opioid overdose. Goal with LIMITx is to develop a treatment for effective pain relief at a one or two tablet dose while providing overdose protection by limiting high peak levels of drug in the bloodstream (Cmax) that can lead to respiratory depression and death when more than the recommended dose is ingested. LIMITx works by neutralizing stomach acid with buffering ingredients as increasing numbers of tablets are swallowed thereby reducing the stomach acid available to cause the release and subsequent systemic absorption of the active ingredient from micro-particles contained in the LIMITx tablets. In a human clinical study, formulations of LTX-03 demonstrated, under fasted conditions, analgesic levels of hydrocodone in the blood when taken at a recommended one or two tablet dose but reduced the maximum blood level (Cmax) up to 34% when subjects were exposed to higher buffer ingredient levels. Hydrocodone with acetaminophen remains the single largest prescribed opioid in the U.S. with excess oral ingestion as the most prevalent method of misuse. Clinical studies with hydromorphone (LTX-04) demonstrated reductions in Cmax of up to 65% when up to 8 tablets were ingested. Analysis of forensic data associated with hydrocodone overdose death suggests a typical consumption of approximately 16 immediate-release tablets, well within the number of tablets in an average filled opioid prescription. The Company intends to demonstrate that a meaningful reduction in Cmax associated with oral overdose can mitigate the risk of respiratory depression and death. LTX-03 may offer safety advantages over existing opioid therapies consistent with the Food and Drug Administration’s (FDA) recently proposed new guidelines for the approval of opioid products.
お知らせ • Feb 15Acura Pharmaceuticals Provides Development Update on LTX-03Acura Pharmaceuticals, Inc. announced that the LTX-03 (hydrocodone bitartrate and acetaminophen) tablets using Acura’s LIMITx technology manufactured in the three New Drug Application (“NDA”) required registration batches successfully passed testing at the six month time point in an ongoing shelf life study when stored at normal temperature and humidity conditions, also known as controlled room temperature (“CRT”). The patented LIMITx technology is a composition of inactive ingredients formulated in a manner that reduces the risks of drug overdose by reducing peak drug levels when inappropriate numbers of tablets are ingested. When stored at high temperature and humidity, also known as accelerated conditions (“AC”), the six month tests revealed the presence of a known derivative of hydrocodone at levels requiring further testing. This known derivative was also detected in the CRT samples and intermediate condition (“IC”) samples, those stored at temperatures and humidity between CRT and AC, at levels within normally accepted limits at this stage of development. The company intends to continue the shelf life study with the CRT and IC samples as previously planned. The LTX-03 tablets were produced at the commercial contract manufacturer, in the to-be-marketed formulation, at commercial (equipment and process) scale. The data being generated in the shelf life study is intended to be used to support the manufacturing and shelf life requirements for an NDA. Acura has completed its review of the Advice Letter received in October 2021 from the Food and Drug Administration (“FDA”) regarding proposed clinical study program for LTX-03. The company updated the three pharmacokinetic study protocols submitted to the FDA and drafted a fourth pharmacokinetic study protocol based on the Advice Letter. These protocols have been provided to development and commercialization partner, Abuse Deterrent Pharmaceuticals, LLC (“AD Pharma”) for comment and determination of the timing of initiation of the studies. The new protocols will require submission to the FDA under the LTX-03 Investigational New Drug (“IND”) application before they can commence.
お知らせ • Jun 08Acura Pharmaceuticals Provides Development Update on LTX-03Acura Pharmaceuticals, Inc. announced the successful completion of three NDA required registration batches of the to-be-marketed LTX-03 formulation. The LTX-03 tablets were manufactured on commercial scale equipment and passed all requisite quality assurance tests. The LTX-03 tablets from these batches will be used in a six month shelf life stability study, which will commence immediately, and in human clinical studies, which will commence after an update to the Investigation New Drug application on file with the Food and Drug Administration (FDA). LTX-03 (hydrocodone with acetaminophen): Recent reports suggest growing numbers of legitimate pain patients are going undertreated as they can no longer find doctors willing to treat them due to new prescribing guidelines associated with the opioid epidemic. Suicide is increasingly seen as the only remedy for some of these patients through opioid overdose. The company's goal with LIMITx is to develop a treatment for effective pain relief at a one or two tablet dose while providing overdose protection by limiting high peak levels of drug in the bloodstream (Cmax) that can lead to respiratory depression and death when more than the recommended dose is ingested. LIMITx works by neutralizing stomach acid with buffering ingredients as increasing numbers of tablets are swallowed thereby reducing the stomach acid available to cause the release and subsequent systemic absorption of the active ingredient from micro-particles contained in the LIMITx tablets. In a human clinical study, formulations of LTX-03 demonstrated, under fasted conditions, analgesic levels of hydrocodone in the blood when taken at a recommended one or two tablet dose but reduced the maximum blood level (Cmax) up to 34% when subjects were exposed to higher buffer ingredient levels. Hydrocodone with acetaminophen remains the single largest prescribed opioid in the U.S. with excess oral ingestion as the most prevalent method of misuse. Clinical studies with hydromorphone (LTX-04) demonstrated reductions in Cmax of up to 65% when up to 8 tablets were ingested. Analysis of forensic data associated with hydrocodone overdose death suggests a typical consumption of approximately 16 immediate-release tablets, well within the number of tablets in an average filled opioid prescription. The Company intends to demonstrate that a meaningful reduction in Cmax associated with oral overdose can mitigate the risk of respiratory depression and death. LTX-03 may offer safety advantages over existing opioid therapies consistent with the Food and Drug Administration’s (FDA) recently proposed new guidelines for the approval of opioid products.
