DUBLIN, Ireland, May 12, 2026
Alkermes announced positive topline results from the pivotal REVITALYZ Phase 3 clinical trial evaluating LUMRYZ® (sodium oxybate) extended-release oral suspension in adults with idiopathic hypersomnia (IH), a rare chronic neurological sleep disorder characterized by excessive daytime sleepiness and severe fatigue. The company reported that the study successfully met its primary endpoint and all key secondary endpoints, demonstrating statistically significant and clinically meaningful improvements compared with placebo. The results mark a major milestone for Alkermes as the company expands its presence in the growing sleep disorder therapeutics market following its acquisition of Avadel Pharmaceuticals earlier this year.
LUMRYZ Demonstrates Significant Improvement in Daytime Sleepiness
According to Alkermes, the REVITALYZ study showed that patients treated with once-nightly LUMRYZ experienced statistically significant improvements in excessive daytime sleepiness measured using the Epworth Sleepiness Scale (ESS) compared with placebo. The company stated the trial achieved a highly significant p-value of p<0.0001, reinforcing the strength of the clinical findings. Key secondary endpoints including the Patient Global Impression of Change (PGI-C) and the Idiopathic Hypersomnia Severity Scale (IHSS) also demonstrated significant improvement among patients who remained on LUMRYZ compared with those switched to placebo during the randomized withdrawal portion of the study.
The Phase 3 REVITALYZ trial enrolled adults with idiopathic hypersomnia across multiple clinical sites using a double-blind, placebo-controlled randomized withdrawal design. All participants initially received open-label LUMRYZ treatment before entering the double-blind withdrawal phase. Researchers observed that patients who transitioned to placebo experienced worsening symptoms while those continuing LUMRYZ maintained clinical benefit, highlighting the therapy’s potential effectiveness for long-term symptom management.
Alkermes also reported that the safety profile observed during REVITALYZ remained consistent with previously known LUMRYZ safety data, with no new safety signals identified. The most common treatment-emergent adverse events included nausea, headache, anxiety, dizziness, and vomiting. The company emphasized that maintaining a consistent safety profile is particularly important for chronic neurological sleep disorders requiring long-term therapy.
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Alkermes Plans FDA Filing for Idiopathic Hypersomnia
Based on the positive Phase 3 findings, Alkermes confirmed plans to submit a supplemental New Drug Application (sNDA) to the U.S. Food and Drug Administration (FDA) by the end of 2026 seeking approval of LUMRYZ for idiopathic hypersomnia. LUMRYZ is currently approved in the United States for treatment of narcolepsy-related excessive daytime sleepiness and cataplexy in patients aged seven years and older, but it is not yet approved for IH.
The positive trial results are strategically important for Alkermes because the company’s acquisition agreement for Avadel Pharmaceuticals included contingent value rights tied to potential FDA approval of LUMRYZ in idiopathic hypersomnia before the end of 2028. Industry analysts believe the successful REVITALYZ readout significantly strengthens the probability of regulatory expansion into the IH market.
Idiopathic hypersomnia remains an underserved neurological condition with limited approved treatment options. The disorder can severely impair cognitive function, work productivity, and quality of life due to persistent daytime sleepiness despite adequate nighttime sleep. Sleep medicine specialists noted that once-nightly therapies like LUMRYZ may provide meaningful advantages over therapies requiring middle-of-the-night dosing, improving patient adherence and convenience.
Alkermes Expands Presence in Sleep Medicine Market
The REVITALYZ data further strengthen Alkermes’ expanding neuroscience and sleep medicine portfolio as the company increasingly invests in rare neurological disorders and next-generation sleep therapeutics. In addition to LUMRYZ, Alkermes is also advancing orexin receptor agonist programs including alixorexton for narcolepsy and hypersomnia-related disorders. The company aims to position itself as a major innovator in sleep medicine as global awareness and diagnosis of neurological sleep disorders continue increasing.
The broader sleep therapeutics market has become increasingly competitive with growing pharmaceutical investment in hypersomnia, narcolepsy, insomnia, and circadian rhythm disorders. Analysts expect demand for differentiated therapies offering improved convenience, efficacy, and safety to continue rising globally as diagnosis rates improve and patient awareness expands. The successful REVITALYZ Phase 3 results place Alkermes in a stronger position to compete within the evolving neuroscience and sleep disorder treatment landscape.
Source: Alkermes press release
