Alkermes said its phase 3 Revitalyz study of Lumryz in adults with idiopathic hypersomnia hit all of its main goals, with the drug showing a statistically significant improvement in excessive daytime sleepiness versus placebo on the Epworth Sleepiness Scale, with p<0.0001.
The trial’s key secondary measures also worsened significantly for patients switched to placebo. From the end of the stable-dose period to the end of the 2-week double-blind withdrawal period, placebo patients showed statistically significant worsening in:
- Patient Global Impression of Change, p<0.0001
- Idiopathic Hypersomnia Severity Scale, p<0.0001
- Epworth Sleepiness Scale, p<0.0001
The study enrolled 104 participants in the randomized withdrawal portion. All participants first received Lumryz during a 10-week open-label titration period, with doses ranging from 4.5 grams to 9 grams, followed by a 2-week stable-dose period before randomization.
Safety findings were described as consistent with Lumryz’s known profile, with no new safety signals. The most common treatment-emergent adverse events, each affecting at least 10% of participants, were nausea, headache, anxiety, dizziness and vomiting.
Alkermes said it plans to present detailed data at a medical meeting and file a supplemental new drug application with the FDA by the end of 2026.
Lumryz is already approved for narcolepsy in patients 7 years and older, but is not yet approved for idiopathic hypersomnia. As a result of these announcements, the company's shares have moved 2.83% on the market, and are now trading at a price of $36.475. For the full picture, make sure to review Alkermes's 8-K report.
