Treatment of cataplexy trial#
The FDA approval of LUMRYZ was supported by results from REST-ON, a randomized, double-blind, placebo-controlled, pivotal Phase 3 trial in adults with narcolepsy. LUMRYZ, is an extended-release sodium oxybate medication approved by the FDA on May 1, 2023, as the first and only once-at-bedtime treatment for cataplexy or excessive daytime sleepiness (EDS) in adults with narcolepsy. Participants may register for the conference call here and are advised to do so at least 10 minutes prior to joining the call.Ībout LUMRYZ ™ (sodium oxybate) for extended-release oral suspension In the REST-ON Phase 3 trial, once-at-bedtime LUMRYZ demonstrated highly statistically significant (p 5% and greater than placebo) reported for all doses of LUMRYZ combined were nausea, dizziness, enuresis, headache, and vomiting.Ī live audio webcast of the call can be accessed by visiting the investor relations section of the Company’s website, A replay of the webcast will be archived on Avadel’s website for 90 days following the event.
The FDA’s final approval of LUMRYZ was based on positive results from the pivotal Phase 3 REST-ON clinical study completed in March 2020. Thorpy, M.D., an investigator from the REST-ON Phase 3 trial and Director at the Sleep-Wake Disorders Center at Montefiore Medical Center and Professor of Neurology at the Albert Einstein College of Medicine. The once-at-bedtime dosing regimen of LUMRYZ may help restore a more natural sleep-wake cycle,” said Michael J. “This long-awaited therapy for people living with narcolepsy fills a critical unmet need by avoiding the burden of a second middle-of-the-night dose that immediate-release oxybate products require. Additional symptoms can vary by person but may include disrupted nighttime sleep, a sudden loss of muscle tone usually triggered by strong emotion (cataplexy), sleep paralysis and hallucinations. The condition affects approximately one in 2,000 people in the United States with the cardinal symptom of EDS. Narcolepsy is a chronic neurological condition that impairs the brain's ability to regulate the sleep-wake cycle. “We would like to thank the patients, caregivers, clinical trial investigators, healthcare providers, and advocates who have tirelessly partnered with us throughout the drug development process and look forward to providing the narcolepsy community access to now approved LUMRYZ.”
Treatment of cataplexy full#
LUMRYZ can now offer people with narcolepsy the opportunity for an uninterrupted night sleep while receiving the full benefit of their prescribed treatment in one single bedtime dose that addresses their symptoms of narcolepsy,” said Greg Divis, Chief Executive Officer of Avadel. As we have heard from key stakeholders, previously approved narcolepsy therapies have the potential to disrupt sleep by either causing insomnia or through forced awakening during the middle of the night for their crucial second dose. “Today’s landmark approval and receipt of Orphan Drug Exclusivity represents a major milestone for both Avadel and people living with narcolepsy. LUMRYZ was additionally granted Orphan Drug Exclusivity by the FDA. With final approval, LUMRYZ becomes the first and only FDA approved once-at-bedtime oxybate for people living with narcolepsy. Food & Drug Administration (FDA) has granted final approval to LUMRYZ, an extended-release formulation of sodium oxybate indicated to be taken once at bedtime for the treatment of cataplexy or excessive daytime sleepiness (EDS) in adults with narcolepsy. ET -ĭUBLIN, (GLOBE NEWSWIRE) - Avadel Pharmaceuticals plc (Nasdaq: AVDL), a biopharmaceutical company focused on transforming medicines to transform lives, announced today that the U.S. Management to host conference call today, at 4:00 p.m.
Final approval supported by robust efficacy and safety data from pivotal Phase 3 REST-ON clinical trial. Advanced commercial preparations on track LUMRYZ product availability expected in early June.
Granted Orphan Drug Exclusivity through.
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