The U.S. Food and Drug Administration (FDA) has approved SYMBRAVO for the acute treatment of migraine, with or without aura, in adults. This approval represents a significant advancement in migraine management, as SYMBRAVO’s dual-action formula targets multiple pathways involved in the condition. The medication delivers rapid relief, allowing patients to resume daily activities after a single dose.
SYMBRAVO is effective in eradicating migraine pain, and its therapeutic effects for migraine patients start from 24 to 48 hours post-medication administration. The treatment demonstrates efficacy across all migraine stages, supporting the treatment of mild, moderate, and severe headache cases. The medication provides beneficial treatment effects for all patients who have suffered from acute migraine attacks previously. The pharmaceutical company Axsome Therapeutics plans to introduce SYMBRAVO in the U.S. market in the upcoming four months.Â
The neurological disorder Migraine affects 39 million people within the American population. It causes severe headaches, nausea, and sensitivity to light and sound that significantly impact quality of life. The American Migraine Foundation recognizes migraine as the leading cause of disability among neurological conditions in the U.S. Surveys results indicate around 70% of those affected do not achieve proper relief from available oral medications.
SYMBRAVO consists of MoSEIC meloxicam and rizatriptan. Axsome has developed MoSEIC (Molecular Solubility Enhanced Inclusion Complex) technology to improve the new molecular entity meloxicam, allowing fast absorption and maintaining plasma stability. Meloxicam functions as a COX-2 preferential non-steroidal anti-inflammatory drug (NSAID) within SYMBRAVO to work with rizatriptan, a 5-HT1B/1D agonist, for providing rapid, effective, and consistent relief from migraine pain and lowering the risk of symptom recurrence.
The FDA’s approval is based on three key clinical trials:
The MOMENTUM trial showed that SYMBRAVO provides significant pain relief and reduce the migraine symptoms like phonophobia, photophobia, and nausea within two hours of administration. Most of them maintained these benefits for up to 48 hours. Analysis revealed the better pain outcomes than rizatriptan monotherapy. A single dose produced noticeable treatment effects within short period after administration, and 77% of patients remained migraine-free in 24 hours without needing rescue medication.
The early treatment of migraine patients in the INTERCEPT Trial resulted in similar significant pain-free outcomes alongside symptom relief results as compared to placebo. Multiple patients maintained their initial 2-hour pain-free state from 24 hours through 48 hours after treatment. Additionally, 85% of the patients treated with SYMBRAVO in the INTERCEPT trial did not need rescue medication within 24 hours post-dose.
Long-term safety was established in the MOVEMENT trial by assessing 706 patients who intermittently used SYMBRAVO for up to 12 months and treating at least two migraines each month. Axsome Therapeutics CEO Herriot Tabuteau, MD, declared that SYMBRAVO attained FDA approval marks a significant advancement in migraine treatment solutions. It provides one-time usage to stop and prevent attacks.
According to MD Stewart Tepper, Clinical Professor of Neurology at the Geisel School of Medicine, the medical community requires treatment solutions that effectively manage migraine outbreaks while showing good tolerance in patients. He acknowledges the potential in SYMBRAVO’s multi-mechanistic features.
Reference: GlobeNewswire. Axsome Therapeutics Announces FDA Approval of SYMBRAVO® (meloxicam and rizatriptan) for the Acute Treatment of Migraine with or without Aura in Adults. Published January 30, 2025. Accessed February 4, 2025. https://www.globenewswire.com/news-release/2025/01/30/3018389/0/en/Axsome-Therapeutics-Announces-FDA-Approval-of-SYMBRAVO-meloxicam-and-rizatriptan-for-the-Acute-Treatment-of-Migraine-with-or-without-Aura-in-Adults.html
