Axsome Therapeutics’ SYMBRAVO was recently approved by the U.S. Food and Drug Administration (FDA). It combines a fast-acting serotonin receptor agonist, rizatriptan with meloxicam, a potent COX-2 preferential, nonsteroidal anti-inflammatory drug (NSAID). Using Molecular Solubility Enhanced Inclusion Complex (MoSEIC) rapid-absorption technology to speed up meloxicam absorption four times faster, SYMBRAVO offers quick relief for acute migraines.
In Phase 3 trials, 85% of patients in the INTERCEPT trial and 77% in the MOMENTUM trial didn’t need rescue medication within 24 hours. The most common adverse events observed during the trials were tiredness and dizziness. While effective for both mild and severe migraine attacks, the presence of NSAID makes SYMBRAVO a black-boxed warning drug with the risk for cardiovascular and gastrointestinal (GI) side effects including heart attack, stroke, GI bleeding, ulceration, and perforation of the stomach or intestines, some of which can be fatal. It is not recommended for individuals with coronary artery bypass graft (CABG) surgery and children. It is neither a preventative treatment of migraine attacks nor for the treatment of hemiplegic or basilar migraines and cluster headaches.
While symptoms may vary from person to person, the most common features of migraine include recurrent attacks of pulsating, often severe and disabling headaches associated with nausea, sensitivity to light, sound, and touch. It is usually misunderstood, mis- or underdiagnosed. Globally, it affects more than 1 billion people. In the United States, an estimated 39 million people suffer from it, and it is the leading cause of disability among neurological disorders. Data from extensive surveys of migraine sufferers indicate that in 70% of the cases, current oral therapies are inadequate in treating acute migraine.
Although the mechanism of its action is unclear, SYMBRAVO acts on four proposed pathways of migraine—neuroinflammation induced by COX2-mediated synthesis of prostaglandins, Calcitonin Gene-Related Peptide (CGRP)-mediated vasodilation of meningeal arteries, CGRP-activated pain signal transmission, and central sensitization responsible for sensory disturbances. It is expected to launch in 2025, addressing the need for fast and consistent migraine relief.
Dr. Rueben Das, Ph.D,
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