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The U.S. Food and Drug Administration (FDA) has granted approval for a novel combination treatment aimed at alleviating migraine pain in adults. The new medication, Symbravo (a combination of rizatriptan and the nonsteroidal anti-inflammatory drug meloxicam), has been cleared for the acute treatment of migraines with or without aura.
Symbravo, developed by Axome Therapeutics, incorporates rapid absorption technology and mechanisms that target multiple migraine pathways, offering a potential solution for the millions of Americans suffering from these debilitating attacks. The drug is expected to be available in approximately four months.
This approval comes after the successful completion of several pivotal phase 3 trials. The MOMENTUM trial, INTERCEPT trial, and the MOVEMENT long-term safety trial involved over 21,000 treated migraine attacks. Results from these studies demonstrated that a single oral dose of the rizatriptan/meloxicam combination provided rapid relief of migraine pain and allowed patients to return to normal functioning within two hours. The effects were sustained for up to 48 hours, with most patients not requiring additional migraine medication within the first 24 hours.
Dr. Richard B. Lipton, Director of the Montefiore Headache Center, commented on the approval, highlighting that many migraine patients experience insufficient relief with current treatments. “Symbravo can provide rapid and long-lasting freedom from migraine pain, whether taken early when the pain is mild or later during a severe attack,” he said. “The approval of Symbravo is a significant advancement, offering a new treatment option for both clinicians and patients.”
However, the drug is not intended for migraine prevention or the treatment of hemiplegic or basilar migraine, nor is it approved for children. Additionally, the combination therapy is not designed to reduce the frequency of migraines or treat cluster headaches.
According to the American Migraine Foundation, more than 39 million Americans are affected by migraine, which is a leading cause of disability among neurological disorders in the U.S.
For more information, including full prescribing details and the medication guide, visit the official online resources provided by the manufacturer.
Disclaimer: This article is for informational purposes only and is not intended as medical advice. Please consult with a healthcare professional before making any medical decisions.
