Avadel Receives FDA Approval on Narcolepsy Drug

Avadel Pharmaceuticals, a biopharmaceutical company, has announced that the FDA has granted final approval to Lumryz, a sodium oxybate intended for treatment of excessive daytime sleepiness (EDS) for people living with narcolepsy. Reportedly, the drug is the only FDA approved once-at-bedtime oxybate of its kind and has been given orphan drug exclusivity through 2030.

The medication comes packaged with a warning of being a potential depressant to the nervous system, only being available under a struct risk evaluation and mitigation strategy.

“Today’s landmark approval and receipt of Orphan Drug Exclusivity represents a major milestone for both Avadel and people living with narcolepsy. 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. 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.

Reference: Avadel Pharmaceuticals Announces Final FDA Approval of LUMRYZ™ (sodium oxybate) for Extended-Release Oral Suspension as the First and Only Once-at-Bedtime Oxybate for Cataplexy or Excessive Daytime Sleepiness in Adults with Narcolepsy. May 1, 2023/Avadel