Avadel’s Lumryz Receives the Full Approval from the US FDA for Cataplexy or Excessive Daytime Sleepiness in Adults with Narcolepsy
Shots:
- The US FDA has granted final approval to Lumryz, an extended-release formulation of sodium oxybate for cataplexy or EDS in adults with narcolepsy. The approval was based on the P-III study (REST-ON) evaluating Lumryz (once-at-bedtime) vs PBO
- The therapy showed an improvement across 3 co-1EPs (maintenance of wakefulness test, clinical global impression improvement & mean weekly cataplexy attacks) for all 3 doses evaluated at 6/7.5/9g. The therapy was clinically superior to currently marketed twice-nightly oxybate products
- The US FDA granted Lumryz seven years of orphan drug exclusivity through May 2030. The product is expected to be available in early June through a restricted program under a Risk Evaluation and Mitigation Strategy i.e., LUMRYZ REMS
Ref: GlobeNewswire | Image: Avadel
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Neha is a Senior Editor at PharmaShots. She is passionate and very enthusiastic about recent updates and developments in the life sciences and pharma industry. She covers Biopharma, MedTech, and Digital health segments along with different reports at PharmaShots. She can be contacted at connect@pharmashots.com.
