Alkermes announced positive topline results from the REVITALYZ phase 3 study evaluating 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 change in Epworth Sleepiness Scale (ESS) score (p<0.0001).
Study Design and Results
The REVITALYZ study was a double-blind, placebo-controlled, randomized withdrawal, multicenter phase 3 trial. All participants received LUMRYZ during a 10-week open-label dose titration period, titrating from 4.5 grams up to a maximum of 9 grams, followed by a 2-week stable dose period. At the end of the stable dose period, 104 participants were randomized to remain on LUMRYZ or switch to placebo for a subsequent 2-week double-blind randomized withdrawal period. Participants randomized to placebo had statistically significant worsening in ESS (p<0.0001), Patient Global Impression of Change (p<0.0001), and Idiopathic Hypersomnia Severity Scale scores (p<0.0001) compared with participants randomized to continue LUMRYZ treatment.
Safety and Regulatory Path
The safety profile of LUMRYZ in the REVITALYZ study was generally consistent with previously observed safety data, with no new safety signals observed. The most common treatment-emergent adverse events (affecting at least 10% of participants) were nausea, headache, anxiety, dizziness, and vomiting. Based on positive results, Alkermes plans to file a supplemental New Drug Application (sNDA) with the FDA by the end of 2026. However, a settlement and license agreement restricts marketing of LUMRYZ for IH before March 1, 2028, even if FDA approval is received earlier.
This article is an AI-assisted summary. All facts and figures are drawn from the original report: https://www.biospace.com/press-releases/alkermes-announces-positive-topline-results-from-revitalyz-phase-3-study-evaluating-lumryz-sodium-oxybate-extended-release-in-adults-with-idiopathic-hypersomnia