ALKS · Alkermes plc

Alkermes plc reported compelling topline data from the REVITALYZ study, a double-blind, placebo-controlled, randomized withdrawal phase 3 trial evaluating LUMRYZ (sodium oxybate extended-release) in adults with idiopathic hypersomnia (IH). All participants underwent a 10-week open-label dose titration from 4.5g to max 9g, followed by a 2-week stable dose period, then randomization to continue LUMRYZ or switch to placebo for 2 weeks. LUMRYZ demonstrated statistically significant and clinically meaningful improvements over placebo on the primary endpoint of change in ESS score from stable dose to end of withdrawal (p<0.0001), as well as key secondaries including proportion with worsening on PGI-C (p<0.0001) and change in IHSS score (p<0.0001). These results highlight LUMRYZ's potential as a once-nightly treatment for excessive daytime sleepiness in IH, a rare disorder affecting an estimated 40,000 U.S. patients with limited approved options. The safety profile aligned with prior narcolepsy data, with no new signals and common AEs like nausea and headache. Alkermes intends to present full data at a medical meeting and submit an sNDA to FDA by year-end 2026. However, a prior settlement restricts IH-related marketing, promotion, or distribution before March 1, 2028, even if approved earlier. LUMRYZ is FDA-approved for narcolepsy in patients 7+ years for cataplexy or EDS. This advances Alkermes' sleep medicine pipeline, addressing unmet needs in IH characterized by severe sleep inertia, unrefreshing naps, and cognitive issues.