Avadel Pharmaceuticals Receives Orphan Drug Designation for LUMRYZ in IH

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.

Avadel Pharmaceuticals Receives Orphan Drug Designation for LUMRYZ in IH

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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 (NASDAQ:AVDL) 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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Disclosure: None. This article is originally published at Insider Monkey.