Axsome FDA OK for SYMBRAVO® (meloxicam and rizatriptan) for Acute Treatment of Migraine

 A single oral dose of SYMBRAVO provided rapid migraine pain freedom and return to normal functioning within 2 hours, and sustained efficacy through 24 and 48 hours

85% and 77% of patients treated with a single dose of SYMBRAVO did not require migraine rescue medication within 24 hours in two Phase 3 studies

SYMBRAVO demonstrated superior efficacy across a broad range of migraine severity (mild, moderate, and severe), and in head-to-head evaluation

SYMBRAVO incorporates Axsome’s rapid absorption technology and mechanisms that target multiple migraine attack pathways

Company to host conference call and webcast Friday, January 31, at 8:00 AM Eastern

Axsome will host a conference call and webcast on Friday, January 31, at 8:00 a.m. Eastern Time to discuss the approval of SYMBRAVO. Dr. Stewart Tepper, Clinical Professor of Neurology at the Geisel School of Medicine at Dartmouth and Vice President of the New England Institute for Neurology and Headache, will join the call and will be available to answer questions during the Q&A session. To participate in the live conference call, please dial (877) 405-1239 (toll-free domestic) or +1 (201) 389-0851 (international). A live webcast can be accessed on the “Webcasts & Presentations” page of the “Investors” section of the Company’s website at axsome.com. A replay of the webcast will be available for approximately 30 days following the live event.

https://www.globenewswire.com/news-release/2025/01/30/3018389/33090/en/Axsome-Therapeutics-Announces-FDA-Approval-of-SYMBRAVO-meloxicam-and-rizatriptan-for-the-Acute-Treatment-of-Migraine-with-or-without-Aura-in-Adults.html