Axsome expects CRL on migraine therapy AXS-07
Central nervous system (CNS) specialist Axsome Therapeutics (Nasdaq: AXSM) revealed that, on April 22, it was informed by the US Food and Drug Administration that chemistry, manufacturing, and controls (CMC) issues identified during the FDA’s review of the company’s New Drug Application (NDA) for its AXS07 (meloxicam and rizatriptan) product candidate for the acute treatment of migraine are unresolved.
Axsome disclosed the news in a regulatory filing with the US Securities and Exchange Commission.
Based upon the time remaining in the NDA review cycle, the company expects to receive a Complete Response Letter with respect to this NDA on or about the Prescription Drug User Fee Act target action date of April 30, 2022.
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