The U.S. Food and Drug Administration (FDA) issued a Complete Response Letter (CRL) to Axsome Therapeutics, Inc. (NASDAQ:AXSM) regarding its New Drug Application (NDA) for AXS-07 for the acute treatment of migraine.
The NDA is supported by results from Phase 3 MOMENTUM and INTERCEPT trials of AXS-07 in the acute treatment of migraine compared to placebo and active controls.
The CRL identifies concerns related to chemistry, manufacturing, and controls (CMC) considerations, while it did not raise any issues about the clinical efficacy or safety data in the New Drug Application (NDA), Hence AXS-07 may not require any new clinical trials to support the approval.
Herriot Tabuteau, MD, Chief Executive Officer, commented, ”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”.
Axsome Therapeutics is currently trading at $32.02