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. (NASDAQ: AXSM), a biopharmaceutical company developing and delivering novel therapies for the management of central nervous system (CNS) disorders, announced that it has enrolled the first patient in the EMERGE trial of AXS-07 for the acute treatment of migraine.
EMERGE (Evaluating Outcomes of AXS-07 after Acute Gepant Failures) is a Phase 3, open-label, multicenter trial to assess the efficacy and safety of AXS-07 in the acute treatment of migraine in patients with a prior inadequate response to an oral Calcitonin Gene-Related Peptide (CGRP) inhibitor. Approximately 100 patients experiencing migraine attacks will be treated with AXS-07 for up to eight weeks, following an inadequate response to prior treatment with an oral CGRP inhibitor. The two co-primary endpoints will be pain relief and absence of the most bothersome symptom two hours after dosing. The study is being conducted to further elucidate the clinical profile of AXS-07 and is not a regulatory requirement.
About Migraine
Over 37 million Americans suffer from migraine according to the Centers for Disease Control, and it is the leading cause of disability among neurological disorders in the United States according to the American Migraine Foundation. Migraine is characterized by recurrent attacks of pulsating, often severe and disabling head pain associated with nausea, and sensitivity to light and or sound. It is estimated that migraine accounts for $78 billion in direct (e.g. doctor visits, medications) and indirect (e.g. missed work, lost productivity) costs each year in the United States. Published surveys of migraine sufferers indicate that more than 70% are not fully satisfied with their current treatment, that nearly 80% would try a new therapy, and that they desire treatments that work faster, more consistently, and result in less symptom recurrence.
About AXS-07
AXS-07 is a novel, oral, rapidly absorbed, multi-mechanistic investigational medicine for the acute treatment of migraine, consisting of MoSEIC™ meloxicam and rizatriptan. 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. AXS-07 is designed to provide rapid, enhances and consistent relief of migraine, with reduced symptom recurrence. AXS-07 is covered by more than 80 issued U.S. and international patents which provide protection out to 2036. AXS-07 is not approved by the FDA.
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