Alkermes’ narcolepsy drug Lumryz succeeded in a new Phase 3 clinical trial, the company reported, adding fresh efficacy data to a therapy that already holds FDA approval.
Lumryz received FDA clearance for narcolepsy. For an approved drug, a positive Phase 3 is the prerequisite for filing a supplemental NDA, the route that asks FDA to update or expand an existing label. If Alkermes chooses to file, the agency would formally evaluate the new data and decide whether the label warrants changes.
The trial specifics, including which patient population it enrolled and what primary endpoint it hit, weren’t available in published reporting. Those details will matter when Alkermes decides whether, and how broadly, to pursue a supplemental label update.
The Endpoints News briefing that covered the Lumryz result also reported on Vistaagen, Enterprise Therapeutics, Cerevance, and Memento Medicines.
Alkermes hasn’t set a submission timeline. The Phase 3 data now exists; the question is what the company does with it.
— Sarah Chen