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.

Axsome intends to provide potential timing for a resubmission, following consultation with the FDA.

“It is our goal to work with the FDA to fully understand and adequately address their comments, so that we can make this important new medicine available to patients with migraine as quickly as possible,” Herriot Tabuteau, MD, Axsome CEO, said in a released statement. “The approval of AXS-07 would offer a much-needed new multi-mechanistic treatment option for the millions of people living with this debilitating neurological condition.”

The submitted new drug application was supported by two phase 3 randomized, double-blind, controlled trials of AXS-07, both of which demonstrated statistically significant elimination of migraine pain with use of AXS-07 compared with placebo.