Lumryz (FT218) treats cataplexy and excessive daytime sleepiness caused by narcolepsy.
The FDA has granted Avadel Pharmaceuticals tentative approval for the once-at-bedtime investigational formulation Lumryz (FT218) to treat cataplexy and excessive daytime sleepiness (EDS) caused by narcolepsy. The drug met all required quality, safety, and efficacy standards in clinical trials.1
Unlike its current market counterparts, Lumryz is taken only once at bedtime.1 The extended-release oral suspension of sodium oxybate is used to treat EDS or cataplexy for narcoleptic adults.1
Narcolepsy affects 1 in 2000 people in the United States.2 EDS is the main symptom that characterizes narcolepsy, and 70% of these patients also experience cataplexy, or a sudden weakening of muscles directly associated with strong emotions.2
In the 2020 randomized, double-blind, placebo-controlled, pivotal phase 3 REST-ON trial, Avadel assessed the safety and efficacy of Lumryz in adults with narcolepsy. Avadel evaluated 3 doses of Lumryz, each one showing statistically significant results in EDS (clinician assessment of patient functioning) and reduced cataplexy attacks, compared to the placebo.1
“Tentative approval is an important regulatory step forward and indicates Lumryz could potentially be granted final approval in 11 months or less,” said Greg Divis, chief executive officer at Avadel Pharmaceuticals.1 “We believe once-at-bedtime Lumryz offers the opportunity to positively transform the lives of oxybate eligible patients living with narcolepsy. Our extensive market research indicates Avadel is well-positioned to capture significant share of the oxybate eligible patient population which we estimate to be more than 30,000 patients. We are pursuing all options to accelerate final approval on or before June 2023 and prepare for commercial launch.”1
Nearly 16,000 patients make up the estimated $1.8 billion twice-nightly US narcolepsy oxybate market.1 Avadel expects that Lumryz will contribute to an overall 25%-30% growth in oxybate treatment, further predicting that the potential market could exceed $3.0 billion annually.1
Avadel detailed an action plan to expedite final approval:
Final approval is at the mercy of the US Patent No. 8,731,963 (the “REMS patent”), listed in FDA’s Orange Book.