Alkermes reported that its phase 3 Revitalyz study of sodium oxybate treatment Lumryz met all primary and key secondary endpoints in idiopathic hypersomnia, a rare neurological sleep disorder that causes excessive daytime sleepiness despite a full night of sleep. The positive readout comes three months after Alkermes completed its $2.37 billion acquisition of Avadel, through which the company obtained Lumryz.
The trial results move Lumryz closer to a potential new use in idiopathic hypersomnia. Under the terms of the Avadel acquisition, Alkermes paid $21 per share in cash and included a $1.50-per-share contingent value right linked to the potential FDA approval of Lumryz in idiopathic hypersomnia by the end of 2028.
Based on the phase 3 findings, Alkermes said it plans to file for approval with the U.S. Food and Drug Administration by the end of 2026, which could allow for an early 2028 launch if approved. In idiopathic hypersomnia, Lumryz would enter a market where Jazz Pharmaceuticals’ sodium oxybate treatment Xywav is currently the only FDA-approved product, having gained the indication in 2021 as its main growth driver.
Lumryz has been approved since 2023 for treating sudden muscle weakness or excessive daytime sleepiness in patients with narcolepsy. Detailed findings from the Revitalyz study are expected to be presented at a future medical meeting, although Alkermes described the results positively in a May 12 press release.
Revitalyz was designed as a placebo-controlled withdrawal study in which participants either remained on Lumryz or stopped treatment and received a placebo. On the trial’s primary endpoint, Lumryz demonstrated statistically significant improvement in excessive daytime sleepiness compared with placebo, measured through changes in Epworth Sleepiness Scale scores during a two-week withdrawal period. According to Alkermes, the p-value was below 0.0001.
The study also met secondary endpoints. Patients who switched to placebo experienced statistically significant worsening of symptoms on the 7-point self-administered Patient Global Impression of Change questionnaire and the Idiopathic Hypersomnia Severity Scale, a 14-item measure assessing excessive daytime sleepiness, prolonged nighttime sleep, and sleep inertia. Alkermes reported p-values below 0.0001 for both measures.
Chief Commercial Officer Todd Nichols said during Alkermes’ first-quarter earnings call last week that the company’s expectations for Lumryz in idiopathic hypersomnia are “very high.” He described the condition as an “underdeveloped category,” noting that 40,000 patients have been diagnosed, a number he said is “underrepresented,” while Xywav remains the only FDA-approved treatment on the market.
Lumryz recorded approximately $72 million in sales during the first quarter of 2026, including $39.5 million after Alkermes assumed control of the product in mid-February. Alkermes said it expects full-year Lumryz sales to range between $350 million and $370 million. Jazz, meanwhile, reported first-quarter Xywav sales increased 18% year over year to $408 million.
Alkermes is also evaluating its orexin 2 receptor agonist alixorexton in idiopathic hypersomnia. According to CEO Richard Pops, clinicians have frequently raised the possibility of combining Lumryz with an OX2R therapy. “We’re not going to start that right away,” Pops said. He added that the company first needs to complete the registration program for alixorexton as a monotherapy, while interest continues in understanding both nighttime and daytime aspects of the disease.
Alkermes has announced positive Phase 3 clinical trial results for Lumryz in patients with idiopathic hypersomnia, marking an important milestone in sleep disorder treatment development. The latest findings reinforce the growing position of Alkermes in neuroscience and rare sleep condition therapies.
The successful trial outcome has generated significant attention across the biotechnology and pharmaceutical industries as companies continue investing in treatments for neurological and sleep-related disorders.
Alkermes Achieves Key Clinical Goals
According to the company, the Phase 3 study evaluating Lumryz met important primary and secondary endpoints in patients diagnosed with idiopathic hypersomnia. Alkermes reported improvements in daytime sleepiness and overall patient functioning during the clinical program.
The positive data could support future regulatory submissions and strengthen the commercial outlook for Lumryz within the sleep medicine market.
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