On Thursday, Avadel Pharmaceuticals (NASDAQ:AVDL) announced that its drug LUMRYZ (sodium oxybate) for extended-release oral suspension has been granted Orphan Drug Designation/ODD by the FDA for the treatment of Idiopathic Hypersomnia/IH. The ODD for IH was specifically granted based on the plausible hypothesis that LUMRYZ may offer clinical superiority to existing approved drugs for the same indication.
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This superiority is attributed to its once-nightly dosing regimen, which is believed to provide a major contribution to patient care for individuals with IH, which is a chronic sleep disorder often requiring lifelong treatment. The CEO of Avadel, Greg Divis, underscored the unique value of the company’s next-gen and extended-release oxybate and its potential benefits for IH patients, if approved.
LUMRYZ is currently being evaluated for the treatment of IH in the REVITALYZ trial,which is a double-blind, placebo-controlled, randomized withdrawal, and multicenter Phase 3 study. This study is designed to assess the efficacy and safety of LUMRYZ when administered as a once-at-bedtime dose. The REVITALYZ trial aims to enroll ~150 adults diagnosed with IH, which includes participants switching from immediate-release oxybates and those not currently taking oxybates. Enrollment for this trial is on track to be completed by the year-end of 2025.
Avadel Pharmaceuticals operates as a biopharmaceutical company in the US. The company was formerly known as Flamel Technologies and changed its name to Avadel Pharmaceuticals in January 2017.
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This article is originally published at Insider Monkey.
