Avadel Pharmaceuticals plc (NASDAQ: AVDL) recently received approval from the U.S. Food and Drug Administration (FDA) for a supplemental new drug application (sNDA) seeking label expansion for its narcolepsy treatment, Lumryz. The drug is now approved for managing cataplexy or excessive daytime sleepiness (EDS) in patients seven years and older with narcolepsy in the United States. This positive development led to a 5.1% rise in the company's shares, although the stock has seen a decline of 1.4% year to date, in contrast to the industry's 0.7% decrease.
Lumryz is a once-nightly, extended-release formulation of sodium oxybate. It first received FDA approval on May 1, 2023, for treating cataplexy or EDS in adults with narcolepsy. With its initial approval, Lumryz was awarded seven years of orphan drug exclusivity, highlighting its clinical superiority over existing oxybate treatments. Narcolepsy is a chronic neurological disorder that affects the brain's ability to regulate sleep-wake cycles, and this label expansion allows broader access to Lumryz's benefits for younger patients with narcolepsy.
The expanded labeling includes orphan drug exclusivity for pediatric narcolepsy patients aged seven years and older until October 16, 2031. This ensures that younger patients can benefit from Lumryz's once-nightly dosage, avoiding disruptions to sleep due to additional nighttime treatments. In the second quarter of 2024, Avadel generated $41.5 million in net product revenues from Lumryz sales, with over 1,900 patients on the treatment as of June 30—an increase from more than 1,400 patients on March 31. With pediatric patients comprising around 5% of the total oxybate-treated narcolepsy population, the expanded label is expected to further enhance sales.
Avadel is also conducting a Phase III clinical trial to assess Lumryz's efficacy and safety in treating idiopathic hypersomnia (IH). This double-blind, placebo-controlled, randomized withdrawal, multicenter study is open to both patients currently on twice-nightly oxybate and those not on oxybate treatment. The trial aims to enroll approximately 150 adults diagnosed with IH and includes an open-label extension portion for further evaluation.
Currently, Avadel holds a Zacks Rank #3 (Hold) status. Other well-positioned stocks in the drug/biotech sector include Catalyst Pharmaceuticals (CPRX) and ANI Pharmaceuticals (ANIP). Please be advised that the information provided does not constitute investment advice and is for informational purposes only.
