お知らせ • Oct 06
Petros Pharmaceuticals Announces Positive Outcomes in Label Comprehension Study for Potential Otc Stendra Label
Petros Pharmaceuticals, Inc. announced completion of a pivotal label comprehension study (LCS). Using FDA guidance provided to the company in 2022, the LCS is expected to satisfy a critical step in the organization's progress towards a possible non-prescription version of STENDRA, the Company's prescription erectile dysfunction drug. Akin to a Phase 2a study in clinical development sequencing, this study's purpose is to evaluate the nonprescription Drug Facts Label and consumer comprehension of key guidelines for safe and appropriate use. The study required a consumer to read the Drug Facts Label, then answer a series of use-case scenario questions during a live virtual interview. Powered by a 95% Confidence Interval, the study protocol included approximately 29 primary endpoint questions designed to evaluate the consumer's understanding of the particular use-case with target thresholds ranging from 90% to 95% comprehension respectively. Results showed significant comprehension among the 480 subjects. Stendra® (avanafil), originally launched by Auxilium Pharmaceuticals prior to that company's sale to Endo Pharmaceuticals, is an oral phosphodiesterase 5 (PDE5) inhibitor for the treatment of erectile dysfunction. STENDRA is not for use in women or children. It is not known if STENDRA is safe and effective in women or children under 18 years of age. (A 100-mg and 200-mg tablet can be taken as early as ~15 minutes before sexual activity. STENDRA only works with sexual stimulation and should not be taken more than once a day. STENDRA can be taken with or without food; do not drink too much alcohol when taking STENDRA (for example, more than 3 glasses of wine or 3 shots of whiskey) as it can increase chances of side effects. Of people enrolled in clinical trials, 1.4%, 2.0%, and 2.0%, respectively, stopped taking STENDRA (50 mg, 100 mg, or 200 mg) due to side effects compared to 1.7% on placebo. Stendra® was designed and developed expressly for erectile dysfunction. The Company recently undertook a relaunch of Stendra®, generating gross revenues of approximately $30 million in 2019. Petros intends to accelerate the relaunch of Stendra® with a well-funded commercial organization and refocused strategy. STENDRA can cause blood pressure to drop suddenly to an unsafe level if it is taken with certain other medicines. A sudden drop in blood pressure can cause to feel dizzy, faint, or have a heart attack or stroke. Do not take STENDRA if you: take medicines called nitrates, which are used to treat chest pain (angina) use street drugs called "poppers," such as amyl nitrate and butyl nitrate take medicines called guanylate cyclase stimulators, which include Adempas® (riociguat), a medicine that treats pulmonary arterial hypertension and chronic thromboembolic pulmonary hypertension are allergic to avanafil or any of the ingredients in STENDRA Stop sexual activity and get medical help right away if have symptoms such as chest pain, dizziness, or nausea during sex. Sexual activity can put an extra strain on heart, especially if heart is already weak from a heart attack or heart disease. Discuss health with healthcare provider to ensure are healthy enough for sex. Uncommonly reported side effects include: An erection that will not go away (priapism). If have an erection that lasts more than 4 hours, get medical help right away. Sudden vision loss in one or both eyes. Sudden vision loss in one or both eyes can be a sign of a serious eye problem called non-arteritic anterior ischemic optic neuropathy (NAION). It is uncertain whether PDE5 inhibitors directly cause vision loss. Stop taking STENDRA and call healthcare provider right away if have sudden vision loss in one or both eyes. Sudden hearing decrease or hearing loss. Some people may also have ringing in their ears (tinnitus) or dizziness. Before take STENDRA, tell healthcare provider if you: have or have had heart problems such as a heart attack, irregular heartbeat, angina, or heart failure; have had heart surgery within the last 6 months; have had a stroke; have low blood pressure, or high blood pressure that is not controlled; have a deformed penis shape have had an erection that lasted for more than 4 hours; have problems with blood cells, such as sickle cell anemia, multiple myeloma, or leukemia; have retinitis pigmentosa, a rare genetic (runs in families) eye disease; have ever had severe vision loss, including an eye problem called non-arteritic anterior ischemic optic neuropathy (NAION); have bleeding problems; have or have had stomach ulcers; have liver problems; have kidney problems or are having kidney dialysis; or have any other medical conditions.