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The complete response letter identified the need for additional chemistry, manufacturing, and controls data related the drug product and manufacturing process.
The FDA has issued a complete response letter for Axsome Therapeutics’ meloxicam-rizatriptan combination therapy (AXS-07) for the acute treatment of migraine. The principal reasons given in the CRL relate to chemistry, manufacturing, and controls (CMC) considerations. The CRL identified the need for additional CMC data related to the drug product and manufacturing process.
Axsome officials believe the issues raised in the CRL are addressable and they intend to provide potential timing for a resubmission following consultation with the FDA. No clinical efficacy or safety issues were raised, and no additional clinical studies are required by the FDA to support approval.
“With regards to AXS-07 for migraine, we look forward to engaging with the FDA to address the issues in the recent complete response letter, with the goal of an expeditious resubmission of that NDA,” Herriot Tabuteau, M.D., founder and chief executive officer of Axsome, said in a press release.
The FDA had accepted the company’s application in September 2021. The NDA is supported by results from two phase 3 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 with placebo and active controls.
Previously regulators were concerned that due to COVID-19 pandemic-related travel restrictions, they wouldn’t be able to complete a required inspection of a contract manufacturing facility. Axsome had officials had said they had been notified that the FDA does not anticipate any issues with completing this facility inspection.
Meloxicam is a new molecular entity for migraine enabled by Axsome’s MoSEIC (Molecular Solubility Enhanced Inclusion Complex) technology, which results in rapid absorption of meloxicam while maintaining a long plasma half-life. Meloxicam is a COX-2 preferential non-steroidal anti-inflammatory drug and rizatriptan is a 5-HT1B/1D agonist.