Express delivery doubles painless patients within 2 hours, oral multi-mechanism migraine therapy is expected to be approved next year

▎ WuXi AppTec content team editor On September 14, 2021, Axsome Therapeutics announced that the US FDA has accepted a new drug application (NDA) for the compound migraine therapy AXS-07 with multiple mechanisms of action for the acute treatment of migraine, PDUFA The target date is April 30, 2022
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Migraine is a neurological disease characterized by severe headaches.
Other symptoms that accompany headaches include nausea and sensitivity to sound and light
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More than 10% of the world’s population is affected by migraines, and women are three times more likely to be affected by migraines than men
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Although there are a variety of drugs for the treatment and prevention of migraine, it still has not received enough attention and treatment
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According to statistics, nearly 40% of migraine patients under-reacted when they received the first acute treatment
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AXS-07 is a new, oral, fast-absorbed, multi-mechanism drug under development for the acute treatment of migraine.
Its active ingredients are meloxicam and rizatriptan, and Use Axsome's MoSEIC formula technology
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This technology significantly improves the absorption rate of meloxicam components after oral administration, while maintaining a longer plasma half-life
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The mechanism of action of AXS-07 includes inhibiting the release of CGRP, reversing CGRP-mediated vasodilation, inhibiting neuroinflammation, pain signal transmission and central sensitization
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This application is based on the positive results obtained from two randomized double-blind phase 3 controlled clinical trials MOMENTUM and INTERCEPT
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The INTERCEPT test showed that AXS-07 significantly eliminated the pain symptoms of patients and significantly prevented the progression of pain severity
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Compared with placebo, AXS-07 reached the co-primary endpoint of no headache and no most bothersome symptom (MBS), doubling the proportion of patients with no pain within two hours
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Both trials demonstrated that AXS-07 brought a statistically significant improvement in migraine pain compared with the placebo group and the active control group
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▲AXS-07 reached the common primary endpoint of the INTERCEPT trial (picture source: Axsome's official website) "The FDA's acceptance of AXS-07's NDA is an important milestone for Axsome.
It keeps us away from bringing this multi-mechanism treatment approach.
The goal for migraine patients in need is one step closer
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" Axsome CEO Dr.
Herriot Tabuteau said, "We look forward to continuing to cooperate with the FDA during the review process
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" References: [1] Axsome Therapeutics Announces Fda Acceptance Of New Drug Application For Axs-07 For The Acute Treatment Of Migraine.
Retrieved September 14, 2021, from https://axsometherapeuticsinc.
gcs-web.
com/news-releases/news-release-details/axsome-therapeutics-announces- fda-acceptance-new-drug-0 Disclaimer: WuXi AppTec's content team focuses on introducing global biomedical health research progress
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This article is for the purpose of information exchange only.
The opinions expressed in the article do not represent the position of WuXi AppTec, nor does it mean that WuXi AppTec supports or opposes the views in the article
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This article is not a treatment recommendation either
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If you need guidance on the treatment plan, please go to a regular hospital for treatment
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