Key takeaways:

• LUMRYZ met all primary and key secondary endpoints demonstrating statistically significant and clinically meaningful improvements compared to placebo in excessive daytime sleepiness and patient-reported disease severity.
• The safety profile was consistent with the known safety profile of LUMRYZ, with no new safety signals observed in this population.
• Alkermes plans to file a supplemental New Drug Application with the FDA by the end of 2026.

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.

“The data from REVITALYZ demonstrate the potential utility of once-nightly LUMRYZ as an effective treatment for excessive daytime sleepiness associated with [idiopathic hypersomnia], building upon its established therapeutic value in narcolepsy,” says Richard K. Bogan, MD, FCCP, FAASM, principal of Bogan Sleep Consultants, LLC and associate clinical professor at the University of South Carolina School of Medicine, in a release. “This is a community with limited approved therapeutic options. These findings constitute an important contribution to the clinical understanding of treatment approaches for patients with IH, for whom disruptive symptoms present particular treatment challenges.”

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 on placebo compared to those who 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, PGI-C, and IHSS compared with participants randomized to continue treatment with LUMRYZ.

The safety profile of LUMRYZ in the REVITALYZ study was generally consistent with previously observed safety data associated with the drug, with no new safety signals observed in this population. The most common treatment-emergent adverse events (experienced by 10% or more of participants) were nausea, headache, anxiety, dizziness, and vomiting.

“We look forward to advancing LUMRYZ as a potential treatment for adults with idiopathic hypersomnia based on the clear and compelling outcome of the REVITALYZ study,” says Craig Hopkinson, MD, chief medical officer and executive vice president, research & development at Alkermes, in a release. “Historically, people living with sleep disorders have had limited treatment options from which to choose, and Alkermes is motivated to contribute to the overall clinical landscape of sleep medicine through research such as this.”

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 with the US Food and Drug Administration (FDA) by the end of 2026.

LUMRYZ is currently approved by the FDA for the treatment of excessive daytime sleepiness or cataplexy in patients 7 years of age and older with narcolepsy. It is not currently approved by regulatory authorities for the treatment of idiopathic hypersomnia. 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 idiopathic hypersomnia before March 1, 2028, even if the drug receives FDA approval for the condition prior to that date.

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