Avadel Obtains FDA Nod for Label Expansion Of Narcolepsy Drug Lumryz

Avadel Pharmaceuticals plc (NASDAQ:AVDL) announced that the FDA has approved its supplemental new drug application (sNDA) seeking label expansion of Lumryz.

The drug is now approved in the United States for the treatment of cataplexy or excessive daytime sleepiness EDS in patients aged seven years and older with narcolepsy.

The company’s shares rose 5.1% on the news. 

The stock fell 1.4% year to date compared with the industry‘s 0.7% decline.

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Label Expansion Of AVDL’s Lumryz

Lumryz is a once-at-bedtime formulation extended-release sodium oxybate. It was first approved by the FDA on May 1, 2023, for the treatment of cataplexy or EDS in adult patients with narcolepsy.

Along with the approval, the FDA also granted seven years of orphan drug exclusivity to Lumryz for the treatment of cataplexy or EDS in adults with narcolepsy due to a finding of clinical superiority of Lumryz relative to currently available oxybate treatments.

Narcolepsy is a chronic neurological condition, wherein the brain’s ability to regulate the sleep-wake cycle is impaired.

The latest FDA approval expands the drug’s indication for younger narcolepsy patients.  The drug was also granted orphan drug exclusivity in pediatric narcolepsy patients aged seven years and older through Oct. 16, 2031.

Pediatric patients (seven years and older) living with narcolepsy will now have the same opportunity that adult patients with narcolepsy have — to choose a once-nightly treatment option that does not disrupt sleep for a middle-of-the-night dose.

Lumryz Uptake Boosts AVDL

Avadel generated $41.5 million of net product revenues from the sales of Lumryz in the second quarter of 2024.

As of June 30, there were more than 1,900 patients on Lumryz compared to more than 1,400 as of March 31.

Pediatric patients currently represent approximately 5% of all oxybate-treated narcolepsy patients. Hence, the label expansion of the drug for this population should boost sales.

In addition, a phase III double-blind, placebo-controlled, randomized withdrawal, multicenter study is evaluating the efficacy and safety of Lumryz in idiopathic hypersomnia (IH).  Enrollment is open to patients who are currently being treated with a twice-nightly oxybate and those not taking oxybates. The study, which is expected to enroll approximately 150 adults diagnosed with IH, includes an open-label extension portion.

AVDL’s Rank & Other Stocks To Consider

Avadel carries a Zacks Rank #3 (Hold) at present.  Some other top-ranked stocks in the drug/biotech sector are Catalyst Pharmaceuticals CPRX, ANI Pharmaceuticals ANIP and

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