Alkermes has reported positive top line data from the Phase III REVITALYZ study, assessing the investigational use of extended-release Lumryz (sodium oxybate) oral suspension in adults with idiopathic hypersomnia (IH).
IH is a rare neurological sleep disorder marked by excessive daytime sleepiness despite normal sleep durations.
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The randomised withdrawal, placebo-controlled, multi-centre, double-blind trial met its primary endpoint.
During the open-label dose titration and stable dose periods, all study participants received Lumryz, showing improved Epworth Sleepiness Scale (ESS) scores.
At the end of the stable dose period, participants were randomised to either continue Lumryz or switch to placebo. At the conclusion of the double-blind randomised withdrawal period, the primary endpoint was measured using ESS.
Secondary endpoints included the Patient Global Impression of Change (PGI-C) and Idiopathic Hypersomnia Severity Scale (IHSS) among 104 participants.
From the stable dose period to the randomised withdrawal period’s end, participants on placebo had statistically significant worsening in ESS, PGI-C, and IHSS in comparison to those who continued Lumryz treatment.
Lumryz’s safety profile in the REVITALYZ study was consistent with prior observations and did not reveal new safety signals. Reported adverse events in 10% or more participants included anxiety, dizziness, headache, nausea, and vomiting.
Alkermes chief medical officer and research and development executive vice-president Craig Hopkinson said: “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.
“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 intends to present the detailed results at a forthcoming medical meeting and to file a supplemental new drug application with the US Food and Drug Administration (FDA) by the end of this year.
Although Lumryz is approved by the FDA for excessive daytime sleepiness or cataplexy in narcolepsy (aged seven years and above), it is not yet approved for IH and Alkermes cannot market Lumryz for IH before 1 March 2028.
In April 2025, Alkermes initiated a randomised Phase II trial to assess the efficacy and safety of ALKS 2680 in adults with IH.
