Axsome Therapeutics announces FDA approval of Symbravo

Axsome Therapeutics (AXSM) announced that the U.S. FDA has approved Symbravo for the acute treatment of migraine with or without aura in adults. Symbravo represents a novel multi-mechanistic approach to treating migraine that targets multiple pathways underlying a migraine attack. Symbravo can rapidly eliminate migraine pain and return patients to normal functioning, with efficacy sustained through 24 and 48 hours in some patients after a single dose. The efficacy of Symbravo was demonstrated across a broad range of settings including at the earliest onset of migraine when the pain was mild, in patients with moderate and severe migraine pain, and in those with a history of various responses to prior acute treatments. The company expects Symbravo to be commercially available in the U.S. in approximately four months