Avadel Pharmaceuticals Receives Tentative Approval for Excessive Daytime Sleepiness Drug Lumryz

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:

• Filed a motion in the US District Court for the District of Delaware on June 23, 2022, to delist the REMS patent from FDA’s Orange Book. A court order requiring the patent holder to delist the REMS patent from the Orange Book could provide a pathway for a final approval of Lumryz prior to June 2023.
• Preparing for a claim construction hearing (“Markman hearing”) scheduled for August 31, 2022, that the Court previously stated is needed in order to rule on the pending patent delisting motion.
• Continuing key activities in anticipation of final approval, including planning for the final preparation of the Lumryz REMS program and the continued manufacturing of commercial supply.¹

Final approval is at the mercy of the US Patent No. 8,731,963 (the “REMS patent”), listed in FDA’s Orange Book.

References

1. Avadel Pharmaceuticals Announces Tentative Approval of LUMRYZ™ (sodium oxybate) extended-release oral suspension. Global Newswire. News Release. July 19, 2022. Accessed July 19,2022. https://www.globenewswire.com/news-release/2022/07/19/2481626/0/en/Avadel-Pharmaceuticals-Announces-Tentative-Approval-of-LUMRYZ-sodium-oxybate-extended-release-oral-suspension.html
2. About Narcolepsy. Xyrem. Accessed July 19, 2022.https://www.xyrem.com/narcolepsy-cataplexy-eds-xyrem-information#:~:text=Excessive%20Daytime%20Sleepiness%20(EDS),-Everyone%20with%20narcolepsy&text=People%20with%20narcolepsy%20may%20take,feel%20more%20than%20just%20sleepy