Axsome Therapeutics Announces SYMBRAVO®

NEW YORK, Feb. 24, 2025 (GLOBE NEWSWIRE) — Axsome Therapeutics, Inc. (NASDAQ: AXSM), a biopharmaceutical company leading a new era in the treatment of central nervous system (CNS) disorders, today announced that the EMERGE Phase 3 trial of SYMBRAVO® (MoSEIC™ meloxicam and rizatriptan) in patients experiencing inadequate response to oral CGRP inhibitors met its primary endpoint, with SYMBRAVO demonstrating statistically significantly greater migraine treatment response compared to oral CGRP inhibitors, as measured by the Migraine Treatment Optimization Questionnaire (mTOQ-4). SYMBRAVO is a novel multi-mechanistic approach to treating migraine that targets multiple pathways underlying a migraine attack. In the trial, SYMBRAVO rapidly and substantially improved migraine pain and most bothersome symptoms.

EMERGE was an open-label trial that enrolled migraine patients who were undergoing treatment with an oral CGRP inhibitor for at least one month and experiencing an inadequate response to the oral CGRP inhibitor, with treatment response assessed using the mTOQ-4. Enrolled patients were switched to treatment with SYMBRAVO for their next four attacks. Treatment responses after the oral CGRP inhibitor treatment period and after the SYMBRAVO treatment period were compared. A total of 96 patients were enrolled and 365 migraine attacks were treated with SYMBRAVO in the trial.

EMERGE met the primary endpoint by demonstrating statistically significantly greater migraine treatment response with SYMBRAVO compared to treatment response with prior oral CGRP inhibitors, as assessed by the mTOQ-4 total score (5.2 versus 2.8, p<0.001). Statistically significantly greater proportions of patients achieved clinical response on the 2-hour pain freedom, sustained pain freedom, ability to return to normal activities, and ability to plan daily activities mTOQ-4 items with SYMBRAVO compared to oral CGRP inhibitors:

Pain freedom within 2 hours for most attacks was reported half the time or more by 47.9% of patients after treatment with SYMBRAVO, compared to 1.0% of patients after treatment with oral CGRPs (p<0.001).
Sustained relief of migraine pain for at least 24 hours following a single dose of medication was reported half the time or more by 47.9% of patients after treatment with SYMBRAVO, compared to 16.7% of patients after treatment with oral CGRPs (p<0.001).
The ability to quickly return to normal activities after taking their medication was reported half the time or more by 51.0% of patients after treatment with SYMBRAVO, compared to 11.5% of patients after treatment with oral CGRPs (p<0.001).
The proportion of patients who reported being comfortable enough with their medication to be able to plan daily activities half the time or more was 63.5% after treatment with SYMBRAVO, compared to 26.0% after treatment with oral CGRPs (p<0.001).
Further, SYMBRAVO treatment resulted in a statistically significant improvement in overall quality of life and daily functioning, as assessed by all three domains of the Migraine-Specific Quality of Life Questionnaire (MSQ), compared to after treatment with oral CGRP inhibitors (p=0.003 to <0.001).

Richard B. Lipton, MD, Professor of Neurology and Director of the Montefiore Headache Center, Albert Einstein College of Medicine, commented, “The results of the EMERGE study demonstrate significant improvements in migraine treatment response with SYMBRAVO for patients previously experiencing inadequate response to oral CGRPs based on the mTOQ-4. Migraine is a disabling neurological condition, and the multiple mechanisms of action of SYMBRAVO may be relevant to the complex and heterogenous nature of this serious condition. These data from the EMERGE study are compelling and provide further evidence for the utility of SYMBRAVO across a variety of migraine settings.”

In this population of patients with a prior inadequate response to an oral CGRP inhibitor, SYMBRAVO rapidly and substantially relieved migraine pain within 2 hours, with benefits sustained through 24 and 48 hours after a single dose. Across all treated attacks, pain relief 2 hours after dosing with SYMBRAVO was achieved by 50.0% of patients, with some patients experiencing pain relief as early as 30 minutes after dosing. The pain relief achieved 2 hours after dosing was sustained through 24 and 48 hours by 78% and 75% of patients respectively. Pain freedom and freedom from the most bothersome symptom 2 hours after dosing with SYMBRAVO was achieved by 22.5% and 26.6% of patients, respectively.

Overall improvement of migraine, measured using the Patient Global Impression of Change (PGI-C), was experienced early and in a substantial proportion of patients after treatment with SYMBRAVO. Overall improvement of their migraine was reported by 26.0% of patients 30 minutes post dose, and by 69.2% of patients 2 hours post dose.

SYMBRAVO was well tolerated with a safety profile that was consistent with what has been previously observed in prior studies. The most commonly reported adverse events (≥2%) were fatigue (3.1%), nausea (3.1%), vomiting (2.1%), muscle tightness (2.1%), and dizziness (2.1%).

Herriot Tabuteau, MD, Chief Executive Officer of Axsome Therapeutics, said, “We’re pleased to share the results of the Phase 3 EMERGE trial, which further underscore the robust efficacy of SYMBRAVO and its potential to effectively treat migraine attacks across a range of patient populations with varying pain intensities and prior responses to acute treatments. We look forward to launching SYMBRAVO in the U.S. in the coming months and offering a new treatment option that could make a meaningful difference for patients suffering from this disabling condition.”