The Food and Drug Administration (FDA) has issued a Complete Response Letter (CRL) to Axsome Therapeutics regarding the New Drug Application (NDA) for AXS-07 for the acute treatment of migraine.

AXS-07 is an oral agent that consists of meloxicam, a COX-2 preferential nonsteroidal anti-inflammatory drug, and rizatriptan, a 5-HT1B/1D agonist. The application was supported by data from the randomized, double-blind phase 3 MOMENTUM ( Identifier: NCT03896009) and INTERCEPT ( Identifier: NCT04163185) trials, which assessed the efficacy and safety of AXS-07 for the acute treatment of migraines in adults.

According to the CRL, the application could not be approved in its current form as additional chemistry, manufacturing, and controls data pertaining to the drug product and manufacturing process are needed. The letter did not identify any issues related to clinical efficacy or safety and the Company will not be required to perform additional clinical trials.

“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,” said Herriot Tabuteau, MD, CEO of Axsome. “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 investigational therapy is believed to decrease neuroinflammation, pain signal transmission, and central sensitization through calcitonin gene-related peptide inhibition.


Axsome Therapeutics receives FDA Complete Response Letter for New Drug Application for AXS-07 for the acute treatment of migraine. News release.  May 2, 2022.