The Food and Drug Administration has accepted the New Drug Application for AXS-07 for the acute treatment of migraine.
AXS-07 is an oral agent that consists of meloxicam, a COX-2 preferential nonsteroidal anti-inflammatory drug, and rizatriptan, a 5-HT1B/1D agonist. The investigational therapy is believed to decrease neuroinflammation, pain signal transmission, and central sensitization through calcitonin gene-related peptide inhibition.
The application is supported by data from the randomized, double-blind phase 3 MOMENTUM (ClinicalTrials.gov Identifier: NCT03896009) and INTERCEPT (ClinicalTrials.gov Identifier: NCT04163185) trials that assessed the efficacy and safety of AXS-07 for the acute treatment of migraines in adults.
In the MOMENTUM trial, 1594 patients were randomly assigned 2:2:2:1 to receive AXS-07 (meloxicam 20mg/rizatriptan 10mg), rizatriptan 10mg, meloxicam 20mg, or placebo at earliest onset of migraine pain. In the INTERCEPT trial, 302 patients were randomly assigned 1:1 to receive either AXS-07 or placebo at the earliest onset of migraine pain.
Results from MOMENTUM showed that a greater proportion of patients treated with AXS-07 had significant improvements in pain freedom (19.9% vs 6.7%; P <.0001) and absence of most bothersome symptom (36.9% vs 24.4%; P =.002) at 2 hours after dosing compared with placebo. Moreover, a greater proportion of patients in the AXS-07 arm had sustained pain freedom from 2 to 24 hours after dosing compared with rizatriptan, meloxicam, and placebo.
In the INTERCEPT trial, treatment with AXS-07 resulted in a statistically significantly greater percentage of patients achieving pain freedom (32.6% vs 16.3%; P =.002) and absence of most bothersome symptom (43.9% vs 26.7%; P =.003) at 2 hours after dosing compared with placebo.
The most commonly reported adverse events with AXS-07 were nausea, dizziness, somnolence, and paresthesia.
A Prescription Drug User Fee Act target date of April 30, 2022 has been set for the application.
- Axsome Therapeutics announces FDA acceptance of New Drug Application for AXS-07 for the acute treatment of migraine. News release. Axsome Therapeutics, Inc. Accessed September 14, 2021. https://www.globenewswire.com/news-release/2021/09/14/2296511/33090/en/Axsome-Therapeutics-Announces-FDA-Acceptance-of-New-Drug-Application-for-AXS-07-for-the-Acute-Treatment-of-Migraine.html.
- Axsome Therapeutics announces axs-07 achieves co-primary and key secondary endpoints in momentum phase 3 migraine trial in patients with history of inadequate response. News release. Axsome Therapeutics, Inc. December 30, 2019. Accessed September 14, 2021. https://axsometherapeuticsinc.gcs-web.com/news-releases/news-release-details/axsome-therapeutics-presents-new-data-momentum-phase-3-trial-axs.
- Axsome Therapeutics completes successful fda pre-nda meeting for axs-07 for the acute treatment of migraine. News release. August 20, 2020. Accessed September 14, 2021. https://axsometherapeuticsinc.gcs-web.com/news-releases/news-release-details/axsome-therapeutics-completes-successful-fda-pre-nda-meeting-0.