Axsome's SYMBRAVO® Meets Primary Endpoint in Phase 3 Migraine Trial

In recent news, Axsome Therapeutics, Inc., a prominent biopharmaceutical company, shared promising results from the EMERGE Phase 3 clinical trial for their migraine treatment, SYMBRAVO®. This innovative treatment combines MoSEIC™ meloxicam and rizatriptan, and is specifically designed for patients who have previously seen inadequate results with oral CGRP inhibitors. The study enrolled 96 participants, who had been using oral CGRP inhibitors for at least a month with limited success, and analyzed their response to SYMBRAVO over four migraine episodes.

The EMERGE trial was able to demonstrate a significant improvement in migraine treatment with SYMBRAVO compared to previous treatments with oral CGRP inhibitors. The main measure of efficacy was the Migraine Treatment Optimization Questionnaire (mTOQ-4) total score, which showed a marked difference (5.2 versus 2.8, p<0.001) in favor of SYMBRAVO. Specifically, 47.9% of patients reported achieving pain freedom within 2 hours of taking SYMBRAVO, a stark contrast to the mere 1.0% who experienced similar relief with oral CGRP inhibitors. Additionally, 47.9% reported sustained pain relief 24 hours or more after a single dose, compared to 16.7% with oral CGRPs.

Furthermore, SYMBRAVO was associated with an improved quality of life as evidenced by the Migraine-Specific Quality of Life Questionnaire (MSQ). Patients noted an enhanced ability to return to normal activities, with 51.0% reporting this benefit after SYMBRAVO treatment versus 11.5% after oral CGRPs. These outcomes were seen as statistically significant improvements, reinforcing the potential of SYMBRAVO as a superior treatment option for those who do not respond adequately to current oral CGRP inhibitors.

Richard B. Lipton, MD, a leading figure in neurology from the Albert Einstein College of Medicine, praised the study's results, highlighting the potential of SYMBRAVO's multi-mechanistic approach to address the complex nature of migraines. The treatment not only provided rapid pain relief but also maintained these benefits over extended periods, with 50% of patients experiencing relief two hours post-dose, some as early as 30 minutes. This effect was sustained in 78% of patients for 24 hours and in 75% for 48 hours. Notably, 22.5% achieved complete pain freedom, and 26.6% were free from their most bothersome symptoms two hours after treatment.

In terms of patient experience, a significant portion reported an overall improvement in their condition. After using SYMBRAVO, 26.0% noticed a positive change within 30 minutes, with this figure rising to 69.2% two hours after administration. The safety profile of SYMBRAVO was consistent with previous studies, with the most common side effects being fatigue, nausea, vomiting, muscle tightness, and dizziness.

Herriot Tabuteau, MD, CEO of Axsome Therapeutics, expressed enthusiasm about the trial's outcome, underscoring the treatment's robust efficacy across a diverse patient population. The company plans to launch SYMBRAVO in the U.S. soon, offering a new, potentially life-changing option for those afflicted by migraines.

The EMERGE trial, bridging innovation and unmet medical need, showcases SYMBRAVO's potential to transform migraine management. As Axsome Therapeutics prepares for its U.S. launch, this new treatment option could significantly enhance the quality of life for migraine sufferers, providing faster and more consistent relief where existing treatments fall short.