FDA Issues CRL for Migraine Therapy
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.
Herriot Tabuteau, M.D.
“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.
In this episode of the "Meet the Board" podcast series, Briana Contreras, Managed Healthcare Executive editor, speaks with Ateev Mehrotra, a member of the MHE editorial advisory board and a professor of healthcare policy and medicine at Harvard Medical School. Mehtrotra is also a hospitalist at the Beth Israel Deaconess Medical Center in Boston. In the discussion, Contreras gets to know Mehrotra more on a personal level and picks his brain on some of his research interests including telehealth, alternative payment models and price transparency.
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