Axsome Therapeutics Inc (AXSM)

[georgejjl]

No clinical efficacy or safety issues raised and no additional clinical studies required by FDA to support approval

Company plans to engage with FDA toward expeditious resolution of outstanding items

NEW YORK, May 2, 2022 /PRNewswire/ -- Axsome Therapeutics, Inc. (NASDAQ: AXSM), a biopharmaceutical company developing novel therapies for the management of central nervous system (CNS) disorders, today announced that the Company has received a Complete Response Letter (CRL) from the U.S. Food and Drug Administration (FDA) regarding its New Drug Application (NDA) for AXS-07 for the acute treatment of migraine. The CRL did not identify or raise any concerns about the clinical efficacy or safety data in the NDA, and the FDA did not request any new clinical trials to support the approval of AXS-07.

The principal reasons given in the CRL relate to chemistry, manufacturing, and controls (CMC) considerations. The CRL identified the need for additional CMC data pertaining to the drug product and manufacturing process. Axsome believes that the issues raised in the CRL are addressable and 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," said Herriot Tabuteau, MD, Chief Executive Officer 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 NDA is supported by results from two Phase 3 randomized, double-blind, controlled trials of AXS-07 in the acute treatment of migraine, the MOMENTUM and INTERCEPT trials, which demonstrated statistically significant elimination of migraine pain with AXS-07 compared to placebo and active controls.

https://finance.yahoo.com/news/axsome-therapeutics-receives-fda-complete-110000340.html

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