Posted by Michael Wonder on 02 May 2023
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
1 May 2023 - Final approval supported by robust efficacy and safety data from pivotal Phase 3 REST-ON clinical trial.
Avadel Pharmaceuticals announced today that the US 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 in adults with narcolepsy.
