![]() ![]() “People living with narcolepsy will finally have a new treatment option to manage and cataplexy, and the fact that this new oxybate option allows for reduced dosing frequency is a game-changing advancement that shows Avadel’s commitment to understanding the patient experience,” Julie Flygare, JD, president and CEO of Project Sleep, said in the release. In the trial, Lumryz demonstrated statistically significant and clinically meaningful improvement compared with placebo across all three co-primary endpoints - Maintenance of Wakefulness Test, Clinical Global Impression-Improvement and mean weekly cataplexy attacks - at all three evaluated doses of 6 g, 7.5 g and 9 g, the release stated. “We would like to thank the patients, caregivers, clinical trial investigators, health care providers and advocates who have tirelessly partnered with us throughout the drug development process.”įDA approval was based on positive results from the phase 3 REST-ON clinical study completed in March 2020. “Today’s landmark approval and receipt of orphan drug exclusivity represents a major milestone for both Avadel and people living with narcolepsy,” Avadel CEO Greg Divis said in the release. In addition, the FDA reported Lumryz to be clinically superior to twice-nightly oxybate products and granted Lumryz a 7-year market exclusivity, which began May 1, the date of approval. The FDA approved Lumryz an extended-release formulation of sodium oxybate, for the treatment of cataplexy or excessive daytime sleepiness in adults with narcolepsy. The FDA has approved Lumryz, an extended-release formulation of sodium oxybate for the treatment of cataplexy or excessive daytime sleepiness in adults with narcolepsy.Īccording to a press release from Avadel Pharmaceuticals, the approval makes Lumryz, which also was granted orphan drug exclusivity, the first and only FDA-approved once-at-bedtime oxybate for those with narcolepsy. FDA approval was based on positive results from a phase 3 clinical trial. INTRODUCTION Narcolepsy is a clinical syndrome of daytime sleepiness with cataplexy, hypnagogic hallucinations, and sleep paralysis.Lumryz is an extended-release, once-at-bedtime oral suspension for cataplexy or excessive daytime sleepiness in adults with narcolepsy.If you continue to have this issue please contact to Healio Key takeaways: ![]()
0 Comments
Leave a Reply. |
AuthorWrite something about yourself. No need to be fancy, just an overview. ArchivesCategories |