Axsome Therapeutics Announces SYMBRAVO® (meloxicam and rizatriptan) Achieves Primary Endpoint in the EMERGE Phase 3 Trial in Migraine Patients Experiencing Inadequate Response to Oral CGRP Inhibitors

Core Insights - SYMBRAVO demonstrated statistically significant improvements in migraine treatment response compared to oral CGRP inhibitors, achieving the primary endpoint in the EMERGE Phase 3 trial [1][3][8] - The trial showed that 47.9% of patients experienced 2-hour pain freedom after SYMBRAVO, compared to only 1.0% after oral CGRPs [1][5] - SYMBRAVO also provided sustained pain relief for 24 hours or more for 47.9% of patients, significantly higher than the 16.7% seen with oral CGRPs [1][5] Company Overview - Axsome Therapeutics, Inc. is a biopharmaceutical company focused on treating central nervous system disorders, with a portfolio that includes FDA-approved treatments for various conditions [34] - The company aims to address critical gaps in care by developing differentiated products with novel mechanisms of action [34] Trial Details - The EMERGE trial was an open-label study involving 96 patients who had inadequate responses to oral CGRP inhibitors, assessing treatment responses using the Migraine Treatment Optimization Questionnaire (mTOQ-4) [2][8] - Patients switched to SYMBRAVO for their next four migraine attacks, with a total of 365 attacks treated during the trial [2] Efficacy Results - The mTOQ-4 total score improved significantly with SYMBRAVO (5.2) compared to oral CGRPs (2.8), indicating better treatment optimization [3][4] - Key metrics showed that 51.0% of patients could quickly return to normal activities after SYMBRAVO, compared to 11.5% after oral CGRPs [1][5] Quality of Life Improvements - SYMBRAVO treatment resulted in significant improvements in overall quality of life and daily functioning, as measured by the Migraine-Specific Quality of Life Questionnaire (MSQ) [4][6] - The trial results suggest that SYMBRAVO may effectively address the complex and heterogeneous nature of migraine [6] Safety Profile - SYMBRAVO was well tolerated, with a safety profile consistent with previous studies; common adverse events included fatigue and nausea [7] - The trial reported that 26.0% of patients experienced overall improvement of migraine 30 minutes post-dose, increasing to 69.2% at 2 hours [7]