14 September 2021 - Axsome Therapeutics today announced that the U.S. FDA has accepted for filing the Company’s new drug application for AXS-07 for the acute treatment of migraine, and has set a Prescription Drug User Fee Act target action date of 30 April 2022 for the new drug application.
AXS-07 (MoSEIC meloxicam-rizatriptan) is a novel, oral, rapidly absorbed, multi-mechanistic, investigational medicine for migraine.