FDA accepts resubmission of NDA for Axsome’s oral migraine treatment

The FDA has accepted the resubmission of a new drug application for a novel, oral therapeutic intended to treat individuals with acute migraine, according to the manufacturer.

In a press release, Axsome Therapeutics Inc. said that the FDA designated the document as a Class 2 resubmission and has set a Prescription Drug User Fee Act date of Jan. 31, 2025.

In May 2022, the FDA issued a complete response letter to Axsome, stating it would not approve the initial new drug application for AXS-07 based on concerns it had with the drug’s chemistry, manufacturing and controls considerations. The FDA called upon the company to release additional data on the drug and its manufacturing process.

AXS-07 is a multi-mechanistic therapeutic consisting of meloxicam, a COX-2 preferential NSAID, and rizatriptan, a 5-HT1B/1D agonist, enabling AXS-07 to provide rapid and consistent relief of migraine with reduced symptom recurrence, per the release. The drug was associated with improvements in pain compared with placebo in the phase 3 MOMENTUM and INTERCEPT trials.