Clinical TrialMay 12, 2026, 07:12 AM
Alkermes LUMRYZ Phase 3 IH Study Positive on All Endpoints
AI Summary
Alkermes plc announced positive topline results from the REVITALYZSM Phase 3 study evaluating LUMRYZ (sodium oxybate) extended-release oral suspension in adults with idiopathic hypersomnia (IH). The study met all primary and key secondary endpoints, demonstrating statistically significant and clinically meaningful improvements in excessive daytime sleepiness and patient-reported disease severity compared to placebo. The safety profile was consistent with known LUMRYZ data, and Alkermes plans to file an sNDA with the FDA by the end of 2026, though marketing for IH is restricted until March 2028.
Key Highlights
- LUMRYZ met primary endpoint: statistically significant improvement in excessive daytime sleepiness (ESS, p<0.0001).
- LUMRYZ met key secondary endpoints: PGI-C (p<0.0001) and IHSS (p<0.0001) showed significant improvements.
- Safety profile of LUMRYZ was consistent with previously observed data, with no new safety signals.
- Most common adverse events (>=10%) included nausea, headache, anxiety, dizziness, and vomiting.
- Alkermes plans to file a supplemental New Drug Application (sNDA) with the FDA by end of 2026.
- Marketing of LUMRYZ for IH cannot begin before March 1, 2028, due to a settlement agreement.
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