공시 • Apr 09
Jazz Pharmaceuticals Plc Presents Research On Epidiolex And Xywav At The American Academy Of Neurology Annual Meeting
Jazz Pharmaceuticals plc announced that the Company will present six abstracts, including one oral presentation, at the 2026 American Academy of Neurology (AAN) Annual Meeting, taking place April 18-22, 2026, in Chicago. The research demonstrates the breadth of Jazz's neuroscience portfolio spanning epilepsy and sleep disorders, with new clinical data evaluating Epidiolex (cannabidiol) in patients with Lennox-Gastaut syndrome (LGS), Dravet syndrome (DS) or tuberous sclerosis complex (TSC), or other refractory epilepsies; and Xywav (calcium, magnesium, potassium, and sodium oxybates) oral solution in patients with narcolepsy. Highlights at the 2026 AAN Annual Meeting include: An oral presentation showcasing results from the prespecified 6-month intermediate analysis of the ongoing EpiCom Phase 3b/4 study demonstrated reductions in the severity of caregiver- and clinician-reported behavioral problems at 26 weeks after Epidiolex treatment initiation in patients with TSC-associated seizures. Improvements were seen across the TSC-Associated Neuropsychiatric Disorders Self-Report Quantified Checklist (TAND-SQ), Aberrant Behavior Checklist (ABC) subscale scores and Caregiver- and Clinician-Global Impression of Severity (CGI-S) scales. This analysis of over 7,800 patients demonstrates how care variability in a non-standardized and fragmented care environment like epilepsy sheds light on the key factors that may influence whether patients remain on treatment and may help clinicians support treatment continuity. A poster presentation featuring an analysis of adults with narcolepsy from the open-label, single-arm DUET (Develop hypersomnia Understanding by Evaluating low-sodium oxybate Treatment) study evaluating changes in cognitive complaints, daily functioning, work productivity and overall disease burden in patients treated with Xywav dosages >9 grams per night. Improvements in these outcomes were observed in participants who optimized their Xywav dosage to >9 grams per night (up to 12 grams total) when compared to a 9 gram per night dosage. Epidiolex has been approved for use by healthcare regulatory authorities in the U.S., Europe, Great Britain, Canada, Australia, Switzerland, Taiwan, Israel, and New Zealand, among other countries. In the U.S., Epidiolex is indicated for the treatment of seizures associated with Lennox-Gastaut syndrome (LGS), Dravet syndrome (DS) or tuberous sclerosis complex (TSC) in patients one year of age and older. Epidiolex has received approval in the European Union under the tradename Epidyolex for adjunctive use in conjunction with clobazam to treat seizures associated with LGS and DS in patients two years and older, and for adjunctive use to treat seizures associated with TSC, in patients two years of age and older. Epidiolex has received Orphan Drug Designation (ODD) from the U.S. FDA for the treatment of seizures associated with LGS, DS, and TSC. Similarly, Epidyolex received ODD from the European Medicines Agency (EMA) for the same indications. Epidiolex is also being studied in additional forms of epilepsy, including the EpiFOS exploratory study (NCT07233239) in focal-onset seizures. Hepatic Injury: EPIDIOLEX can cause dose-related transaminase elevations. Concomitant use of valproate and elevated transaminase levels at baseline increase this risk. Obtain transaminase and bilirubin levels prior to starting treatment, at 1, 3, and 6 months after initiation of treatment, and periodically thereafter, or as clinically indicated. Resolution of transaminase elevations occurred with discontinuation of EPIDIOLEX, reduction of EPIDIOLEX and/or concomitant valproate, or without dose reduction. For patients with elevated transaminase levels, consider dose reduction or discontinuation of EPIDIOLEX or concomitant medications known to affect the liver. Dose adjustment and slower dose titration is recommended in patients with moderate or severe hepatic impairment. Consider not initiating EPIDIOLEX in patients with evidence of significant liver injury. There have been postmarketing reports of cholestatic or mixed patterns of liver injury. Elevated ammonia levels were reported in some patients with transaminase elevations; most taking concomitant valproate, clobazam, or both. Consider discontinuation or dose adjustment of valproate or clobazam if ammonia is elevated. Somnolence and Sedation: EPIDIOLEX can cause somnolence and sedation that generally occurs early in treatment and may diminish over time; these effects occur more commonly in patients using clobazam and may be potentiated by other CNS depressants. Suicidal Behavior and Ideation: Antiepileptic drugs (AEDs), including EPIDIOLEX, increase the risk of suicidal thoughts or behavior. Inform patients, caregivers, and families of the risk and advise them to monitor and report any signs of depression, suicidal thoughts or behavior, or unusual changes in mood or behavior. If these symptoms occur, consider if they are related to the AED or the underlying illness. Withdrawal of Antiepileptic Drugs: As with most AEDs, EPIDIOLEX should generally be withdrawn gradually because of the risk of increased seizure frequency and status epilepticus. ADVERSE REACTIONS: The most common adverse reactions in patients receiving EPIDIOLEX (=10% and greater than placebo) include transaminase elevations; somnolence; decreased appetite; diarrhea; pyrexia; vomiting; fatigue, malaise, and asthenia; rash; insomnia, sleep disorder and poor-quality sleep; and infections. Hematologic abnormalities were also observed. PREGNANCY: EPIDIOLEX should be used during pregnancy only if the potential benefit justifies the potential risk to the fetus. Encourage women who are taking EPIDIOLEX during pregnancy to enroll in the EPIDIOLEX Pregnancy Surveillance Program and the North American Antiepileptic Drug (NAAED) Pregnancy Registry. DRUG INTERACTIONS: Strong inducers of CYP3A4 and CYP2C19 may affect EPIDIOLEX exposure. EPIDIOLEX may affect exposure to CYP2C19 substrates (e.g., clobazam, diazepam, stiripentol), orally administered P-gp substrates, or other substrates. Consider dose reduction of orally administered everolimus, with appropriate therapeutic drug monitoring, when everolimus is combined with EPIDIOLEX. A lower starting dose of everolimus is recommended when added to EPIDIOLEX therapy. Concomitant use of EPIDIOLEX and valproate increases the incidence of liver enzyme elevations. Pneumonia was observed more frequently with concomitant use of EPIDIOLEX and clobazam. Dosage adjustment of EPIDIOLEX or other concomitant medications may be necessary. INDICATIONS: EPIDIOLEX (cannabidiol) oral solution is indicated for the treatment of seizures associated with Lennox-Gastaut syndrome (LGS), Dravet syndrome (DS), or tuberous sclerosis complex (TSC) in patients 1 year of age and older.