Phase 3 Trial Launches for Acute Migraine Treatment

Biopharmaceutical company Axsome Therapeutics, Inc, has announced the enrollment of the first patient in the EMERGE trial, which will evaluate AXS-07 for the treatment of acute migraine. Co-primary endpoints include pain relief and absence of major symptoms starting 2 hours after taking AXS-07.¹

AXS-07 is an oral, rapidly absorbed, multi-mechanistic novel treatment for acute migraines that combines MoSEIC (Molecular Solubility Enhanced Inclusion Complex) technologies meloxicam and rizatriptan.¹

The phase 3, open-label, multicenter EMERGE (Evaluating Outcomes of AXS-07 after Acute Gepant Failures) trial will evaluate the safety and efficacy of AXS-07 as an on-demand treatment for patients who suffer from migraines but who did not respond to an oral calcitonin gene-related peptide (CGRP) inhibitor.¹

Investigators identified 100 patients who suffer from migraine attacks and did not respond to CGRP inhibitors. They will be treated with AXS-07 for up to 8 weeks and the results will be published in a future report.¹

According to the CDC, more than 37 million Americans suffer from migraines.

“Migraine is characterized by recurrent attacks of pulsating, often severe and disabling head pain associated with nausea, and sensitivity to light and or sound,” Axsome Therapeutics stated in a press release.¹

Migraines can last hours to days if they are left untreated. Migraines can cause a severe throbbing or pulsing sensation—usually occurring on either or both sides of the head—and other common symptoms range from nausea to vomiting, and extreme sensitivity to light and sound.²

Migraines can occur in 4 stages:

Prodrome: Occurs 1 to 2 days before a migraine with milder symptoms of constipation, mood changes, food cravings, neck stiffness, increased urination, and fluid retention.²

Aura: Occurs before or during a migraine and lasts up to 60 minutes. Includes symptoms of the nervous system such as visual phenomena, bright spots, vision loss, pins and needle sensations in the arms and legs, weakness, or numbness in the face or on 1 side of the body, and difficulty speaking.²

Attack: Lasts anywhere from 4 to 72 hours, striking rarely or several times a month. Symptoms include pain (1 or both sides), throbbing pain, sensitivity to light and sound, nausea, and vomiting.²

Post-drome: Post-attack period. Oftentimes, patients feel drained, confused, or even elated.²

Experts estimate migraines affect a $78 billion direct and indirect market, including physician visits and prescriptions, but also resulting in revenue lost for missed work.

References

1. Axsome therapeutics initiates emerge phase 3 open-label trial of axs-07 for the acute treatment of migraine in adults with a prior inadequate response to an oral cgrp inhibitor. Axsome Therapeutics, Inc. website. September 1, 2022. Accessed September 6, 2022. https://axsometherapeuticsinc.gcs-web.com/news-releases/news-release-details/axsome-therapeutics-initiates-emerge-phase-3-open-label-trial
2. Mayo Clinic. What is a Migraine? A Mayo Clinic expert explains. Mayo Clinic website. Accessed on September 6, 2022. https://www.mayoclinic.org/diseases-conditions/migraine-headache/symptoms-causes/syc20360201#:~:text=A%20migraine%20is%20a%20headache,sensitivity%20to%20light%20and%20sound.