Alkermes Plc Announces Positive Topline Results From REVITALYZ? Phase 3 Study Evaluating LUMRYZ® (sodium oxybate) Extended-Release in Adults With Idiopathic Hypersomnia

Published: 2026-05-12 09:05:52 ET ALKS

Published on 05/12/2026 at 09:05 am EDT

Alkermes plc announced positive topline results from the REVITALYZ double-blind, placebo-controlled, randomized withdrawal, multicenter phase 3 study evaluating the investigational use of LUMRYZ (sodium oxybate) extended-release oral suspension in adults with idiopathic hypersomnia (IH). LUMRYZ met the study?s primary endpoint, demonstrating statistically significant improvements in excessive daytime sleepiness compared to placebo as measured by the change in Epworth Sleepiness Scale (ESS) score (p<0.0001). All study participants received LUMRYZ during an open-label dose titration period then a stable dose period, during which improvements in ESS scores were observed.

At the end of the stable dose period participants were randomized to remain on LUMRYZ or switch to placebo. At the end of the double-blind randomized withdrawal period, the primary endpoint of ESS and key secondary endpoints of Patient Global Impression of Change (PGI-C) and Idiopathic Hypersomnia Severity Scale (IHSS) were measured for 104 participants to assess the worsening of symptoms for those participants on placebo as compared to those that remained on LUMRYZ. From the end of the stable dose period to the end of the double-blind randomized withdrawal period, participants randomized to placebo had statistically significant worsening in ESS (p<0.0001), PGI-C Alkermes plans to present detailed results from REVITALYZ at an upcoming medical meeting.

Based on the positive results of this phase 3 study, Alkermes plans to file a supplemental New Drug Application (sNDA) with the U.S. Food and Drug Administration (FDA) by the end of 2026. LUMRYZ is approved by the FDA for the treatment of excessive daytime sleepiness or cataplexy in patients 7 years of age and older with narcolepsy. LUMRYZ is not currently approved by regulatory authorities for the treatment of IH.

Pursuant to the terms of a previously disclosed settlement and license agreement, Alkermes may not market, offer for sale, take orders for, distribute, promote, or provide patient support services with respect to LUMRYZ for IH before March 1, 2028, even if LUMRYZ were to receive FDA approval for IH prior to that date.