FDA declines to move forward with migraine treatment

The FDA has issued a complete response letter to Axsome Therapeutics Inc., in which the agency declined to move forward with a new drug application for AXS-07, an acute treatment for migraine.
According to a release from Axsome, the response letter did not identify or raise any concerns about the efficacy or safety of the drug but instead highlighted chemistry, manufacturing and controls considerations. In the letter, the FDA identified a need for additional data, pertaining to the product and manufacturing process, and did not request new clinical trials to support the drug’s approval.

The FDA has issued a complete response letter to Axsome Therapeutics Inc., in which the agency declined to move forward with a new drug application for AXS-07, an acute treatment for migraine.
According to a release from Axsome, the response letter did not identify or raise any concerns about the efficacy or safety of the drug but instead highlighted chemistry, manufacturing and controls considerations. In the letter, the FDA identified a need for additional data, pertaining to the product and manufacturing process, and did not request new clinical trials to support the drug’s approval.