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Avadel Pharmaceuticals Receives Orphan Drug Designation from FDA for LUMRYZ™ (sodium oxybate) for Extended-Release Oral Suspension for the Treatment of Idiopathic Hypersomnia
GlobeNewswire News Room· 2025-06-05 11:30
DUBLIN, June 05, 2025 (GLOBE NEWSWIRE) -- Avadel Pharmaceuticals plc (Nasdaq: AVDL), a biopharmaceutical company focused on transforming medicines to transform lives, announced today that LUMRYZTM has been granted Orphan Drug Designation (ODD) from the U.S. Food & Drug Administration (FDA) for the treatment of Idiopathic Hypersomnia (IH). Specifically, ODD was granted based on the plausible hypothesis that LUMRYZ may be clinically superior to the same drug(s) already approved for the same indication, becaus ...
Avadel Pharmaceuticals to Present New Data on LUMRYZ™ (sodium oxybate) For Extended-Release Oral Suspension at SLEEP 2025
Globenewswire· 2025-05-29 20:05
– 14 abstracts accepted, including four oral presentations – – Interim analysis of real-world REFRESH study demonstrated clinically significant efficacy and improvement of EDS for patients who switched from twice-nightly oxybate to once-at-bedtime LUMRYZ – – Data reflecting the therapeutic results of LUMRYZ treatment in people with narcolepsy across clinical as well as real-world settings will be presented – DUBLIN, Ireland, May 29, 2025 (GLOBE NEWSWIRE) -- Avadel Pharmaceuticals plc (Nasdaq: AVDL), a biop ...