Avadel Pharmaceuticals plc announced that it has finished enrolling patients in its Phase 3 REVITALYZ trial, a double‑blind, placebo‑controlled study evaluating LUMRYZ as a once‑at‑bedtime treatment for idiopathic hypersomnia (IH). The multicenter trial, which recruited participants from 40 U.S. sleep centers, is now fully staffed and ready to begin the final 14‑week treatment period, bringing the company one step closer to a potential FDA approval for a condition that currently has only one approved therapy.
Idiopathic hypersomnia affects an estimated 40,000–42,000 patients in the United States, a population that experiences severe daytime sleepiness and debilitating sleep inertia. LUMRYZ’s extended‑release formulation, administered once at bedtime, offers a distinct advantage over existing twice‑nightly oxybate regimens by improving patient convenience and potentially enhancing adherence. The trial’s primary endpoint—change in Epworth Sleepiness Scale score at week 14—will determine whether the drug can meet the regulatory standard for efficacy in this underserved market.
Avadel’s progress in the REVITALYZ trial is set against the backdrop of its pending acquisition by Alkermes, which agreed to purchase the company for up to $20.00 per share, valuing Avadel at roughly $2.1 billion. The deal is expected to close in the first quarter of 2026, and a contingent value right tied to the successful commercialization of LUMRYZ for IH by the end of 2028 is a key component of the transaction. The acquisition provides Avadel shareholders with a clear exit path while giving Alkermes a high‑potential asset in a niche therapeutic area.
In addition to the acquisition context, LUMRYZ has received Orphan Drug Designation from the FDA for idiopathic hypersomnia, a status that grants market exclusivity and other development incentives. The designation underscores the drug’s potential to address a rare disease with limited treatment options and signals regulatory support for the company’s development program.
The completion of enrollment positions Avadel to advance the trial to the final treatment phase, potentially leading to FDA approval and a broadened revenue base that could double the company’s addressable market. Management has highlighted the milestone as a critical step toward expanding LUMRYZ beyond narcolepsy, while the legal victories affirming the drug’s clinical superiority over competing oxybates reduce commercial risk. Investors have responded positively, citing the trial’s progress, the strategic value of the Alkermes deal, and the regulatory momentum surrounding LUMRYZ’s orphan designation.
The content on BeyondSPX is for informational purposes only and should not be construed as financial or investment advice. We are not financial advisors. Consult with a qualified professional before making any investment decisions. Any actions you take based on information from this site are solely at your own risk.