Axsome Therapeutics, Inc., an U.S.-based biopharmaceutical company developing and delivering novel therapies for the management of central nervous system (CNS) disorders, today announced that the U.S. Food and Drug Administration (FDA) has acknowledged the resubmission of the Company’s New Drug Application (NDA) for AXS-07 for the acute treatment of migraine. 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. MoSEIC™ is defined in Axsome Therapeutics’s related granted patent (US 11,013,806), that it is meant as complexing with betadex sulfobutylether sodium.
Axsome Therapeutics’ betadex sulfobutylether sodium containing composition: FDA Acceptance of NDA Resubmission
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