DUBLIN — Alkermes plc said its once-nightly LUMRYZ treatment met the primary and key secondary goals in a phase 3 study evaluating its investigational use in adults with idiopathic hypersomnia, a rare chronic sleep disorder.
The Dublin-based company said the REVITALYZ study showed statistically significant and clinically meaningful improvements compared with placebo in excessive daytime sleepiness and patient-reported disease severity. LUMRYZ, an extended-release formulation of sodium oxybate, is already approved by the U.S. Food and Drug Administration to treat excessive daytime sleepiness or cataplexy in patients 7 and older with narcolepsy, but it is not approved for idiopathic hypersomnia.
The trial met its primary endpoint, showing statistically significant improvement in excessive daytime sleepiness compared with placebo, as measured by the Epworth Sleepiness Scale. Alkermes said the result had a p-value of less than 0.0001.
“The data from REVITALYZ demonstrate the potential utility of once-nightly LUMRYZ as an effective treatment for excessive daytime sleepiness associated with IH, building upon its established therapeutic value in narcolepsy,” said Richard K. Bogan, M.D., FCCP, FAASM, Principal of Bogan Sleep Consultants, LLC and Associate Clinical Professor at the University of South Carolina School of Medicine. “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.”
In the study, all participants received LUMRYZ during an open-label dose titration period, followed by a stable dose period. Participants were then randomized either to remain on LUMRYZ or switch to placebo during the double-blind randomized withdrawal period.
Alkermes said 104 participants were evaluated at the end of the withdrawal period. Participants switched to placebo had statistically significant worsening compared with those who continued LUMRYZ on the Epworth Sleepiness Scale, Patient Global Impression of Change and Idiopathic Hypersomnia Severity Scale, with p-values of less than 0.0001 across all three measures.
The company said the safety profile in the study was generally consistent with previously observed safety data for LUMRYZ, with no new safety signals seen in this patient population. The most common treatment-emergent adverse events, reported in at least 10% 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,” said Craig Hopkinson, M.D. (MBChB), Chief Medical Officer and Executive Vice President, Research & Development at Alkermes. “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 said it plans to present detailed results from the study at an upcoming medical meeting. Based on the phase 3 results, the company plans to file a supplemental New Drug Application with the FDA by the end of 2026.
The company noted that, under a previously disclosed settlement and license agreement, it may not market, sell, distribute, promote or provide patient support services for LUMRYZ for idiopathic hypersomnia before March 1, 2028, even if the treatment receives FDA approval for that use before then.
Idiopathic hypersomnia is a rare neurological sleep disorder marked by excessive daytime sleepiness despite normal sleep duration. Other symptoms can include severe sleep inertia, unrefreshing naps, fatigue and cognitive dysfunction. Alkermes said the condition affects an estimated 40,000 people in the U.S.
