The FDA assigned a Prescription Drug User Fee Action date is January 31, 2025.
The FDA accepted a new drug application resubmission for AXS-07 for the acute treatment of migraine. The Prescription Drug User Fee Action date is now January 31, 2025.1
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AXS-07 is a novel, rapidly absorbed investigational medication consisting of molecular solubility enhanced inclusion complex (MoSEIC) meloxicam and rizatriptan. The mechanism of action involves inhibiting the calcitonin gene-related peptide (CGRP) release, reversing CGRP-mediated vasodilation. In response, it inhibits the neuroinflammation, pain signal transmission, and central sensitizations. The MoSEIC technology results in a shorter absorption rate while retaining the plasma half-life of the medication, according to the company.2
In a session at the 2024 American Academy of Neurology Annual Meeting, Melissa Rayhill, MD, FAAN, associate professor of neurology at the University of Buffalo Jacobs School of Medicine, said that migraine is often a whole body phenomenon, with neurological, sensory, autonomic, vestibular, cognitive, and gastrointestinal symptoms. Over 47 million Americans are reported to experience migraine, including 10% of school-age children experiencing. It is also the leading cause of disability for adults under the age of 50 worldwide.3
Investigators conducted 2 phase 3 clinical trials that were published in Neurology, intended to evaluate the efficacy of AXS-07 in patients with risk factors for inadequate treatment response to acute treatment of migraine. Risk factors included higher body mass index (BMI), allodynia, morning migraine, and history of depression. There were 2 clinical trials included in the pool were MOMENTUM and INTERCEPT with 1594 patients and 352 patients, respectively. The trials included individuals with a history of inadequate response to prior acute treatments. In MOMENTUM, individuals received AXS-07, rizatriptan, MoSEEIC meloxicam, or the placebo to treat a single migraine attack (moderate or severe intensity). For INTERCEPT, patients received either a single dose of AXS-07 or the placebo at the earliest sign of migraine pain (when pain was still mild).4
Investigators pooled the 2-hour pain freedom rates of the medication compared with the placebo for the patient populations, finding that the rates were 19.1% with AXS-07 compared with 9.9% the placebo for BMI, 23.3% and 11% for allodynia, 23.5% and 10.5% for morning migraine, and 23.1% and 5.9% for history of depression, respectively, according to the study authors.4
In an additional analysis in 2024, investigators found that AXS-07 demonstrated greater headache pain freedom at 23% compared with the placebo at 11% and 39% and 25%, respectively, for the most bothersome symptom at 2 hours. Further, there was sustained pain freedom between 2 and 24 hours at 18% and 8% as well as 48 hours at 16 and 7%, respectively. Rescue medication use also declined through 24 hours at 43% and 21%, respectively.5
Treatment-emergent adverse events (TEAEs) were experienced by 12.7% of individuals taking AXS-07 and 6.6% taking the placebo. The most common TEAEs for AXS-07 were nausea at 2.4%, somnolence at 2.1%, and dizziness at 1.9%.4,5
