## Avadel Pharmaceuticals’ Lumryz Gets FDA Approval for Younger Narcolepsy Patients: A Boon for Pediatric Care
Avadel Pharmaceuticals plc (NASDAQ: AVDL) has secured a significant victory in its quest to expand the reach of its narcolepsy treatment, Lumryz. The FDA has granted approval for a supplemental new drug application (sNDA) that extends the indication of Lumryz to encompass the treatment of cataplexy or excessive daytime sleepiness (EDS) in patients aged seven years and older with narcolepsy.
This approval marks a pivotal moment in the landscape of pediatric narcolepsy treatment. Lumryz, a once-at-bedtime formulation of extended-release sodium oxybate, now offers a convenient and effective treatment option for younger patients. Prior to this expansion, Lumryz was approved for adults with narcolepsy, but the FDA’s decision to expand the drug’s label to include pediatric patients is a testament to its efficacy and safety profile, providing much-needed relief for young individuals battling this chronic neurological condition.
Narcolepsy is a disorder characterized by the brain’s inability to effectively regulate the sleep-wake cycle. The condition can manifest in a range of symptoms, including excessive daytime sleepiness, cataplexy (sudden loss of muscle control), sleep paralysis, and hypnagogic hallucinations. The FDA’s approval of Lumryz for younger narcolepsy patients underscores the commitment to improving the lives of individuals living with this challenging condition.
The news of the FDA approval was met with positive market response, as Avadel’s shares rose 5.1% following the announcement. The company’s strategic focus on expanding Lumryz’s market potential is evident in the company’s continued success. The drug has already garnered significant traction, generating $41.5 million in net product revenues in the second quarter of 2024. Notably, as of June 30, over 1,900 patients were receiving treatment with Lumryz, a significant increase from the 1,400 patients reported as of March 31.
With pediatric patients currently representing approximately 5% of all oxybate-treated narcolepsy patients, the label expansion of Lumryz is anticipated to fuel substantial growth in the drug’s sales. The ability to provide a single-dose, nighttime treatment option that aligns with the needs of young patients is expected to drive increased adoption and further solidify Lumryz’s position as a leading treatment option for narcolepsy.
Avadel is not resting on its laurels. The company is actively pursuing further clinical studies to explore the potential of Lumryz in treating other sleep disorders. A phase III double-blind, placebo-controlled, randomized withdrawal, multicenter study is currently underway to evaluate the efficacy and safety of Lumryz in the treatment of idiopathic hypersomnia (IH). This study, which is expected to enroll approximately 150 adults diagnosed with IH, includes an open-label extension portion, demonstrating Avadel’s commitment to expanding the therapeutic applications of Lumryz beyond narcolepsy.