Avadel Pharmaceuticals Receives Orphan Drug Designation from FDA for LUMRYZ™ (sodium oxybate) for Extended-Release Oral Suspension for the Treatment of Idiopathic Hypersomnia

Core Viewpoint - Avadel Pharmaceuticals has received Orphan Drug Designation from the FDA for LUMRYZ, aimed at treating Idiopathic Hypersomnia, highlighting its potential clinical superiority due to once-nightly dosing [1][2][3] Company Overview - Avadel Pharmaceuticals plc is a biopharmaceutical company focused on developing innovative therapies for rare sleep disorders [2][21] - The company aims to transform patient care through differentiated therapies, particularly for conditions like Idiopathic Hypersomnia [2][21] Product Information - LUMRYZ is an extended-release sodium oxybate medication, approved as the first and only once-at-bedtime treatment for cataplexy or excessive daytime sleepiness in adults and pediatric patients with narcolepsy [4][6][21] - The FDA granted LUMRYZ Orphan Drug Exclusivity for seven years due to its clinical superiority over existing treatments [6] Clinical Trials - LUMRYZ is currently being evaluated in the REVITALYZ trial, a Phase 3 study designed to assess its efficacy and safety in approximately 150 adults diagnosed with Idiopathic Hypersomnia [2][5] - The trial is expected to be completed by the end of 2025, with enrollment open for participants switching from immediate-release oxybates and those not currently on oxybates [2][5] Regulatory Designation - Orphan Drug Designation is granted to drugs that show promise for treating rare diseases affecting fewer than 200,000 people in the U.S., providing benefits such as market exclusivity and FDA assistance in clinical trial design [3]