The US Food and Drug Administration (FDA) has approved Symbravo (rizatriptan/meloxicam), a novel oral combination therapy for the acute treatment of migraine with or without aura in adults. Developed by Axsome Therapeutics, Symbravo leverages rapid absorption technology to target multiple migraine pathways, offering rapid and sustained relief.
The approval is backed by robust phase 3 trials, including MOMENTUM, INTERCEPT and MOVEMENT, which collectively treated over 21,000 migraine attacks. Results showed that a single dose of Symbravo provided rapid pain freedom and restored normal function within 2 hours, with effects lasting up to 48 hours. Notably, most patients did not require rescue medication within 24 hours.
Dr. Richard B. Lipton, Director of the Montefiore Headache Center, emphasized the significance of this advancement: "Results of multiple clinical trials demonstrate that Symbravo can provide rapid and long-lasting freedom from migraine pain, whether treatment is taken early in the attack while the pain is mild, or later in the attack when the pain may be severe. The approval of Symbravo is a long-awaited and much-welcomed advancement for clinicians and our patients."
Symbravo combines the fast-acting 5-HT1 receptor agonist "rizatriptan" with the COX-2 preferential NSAID "meloxicam", utilizing Axsome’s proprietary technology to enhance absorption and prolong plasma half-life. This dual mechanism inhibits CGRP release, reverses vasodilation, and blocks neuroinflammation and pain signaling.
The therapy is expected to be available within four months and is not intended for migraine prevention, hemiplegic or basilar migraine, or cluster headaches. It is also not approved for pediatric use. This approval marks a significant step forward in addressing unmet needs for acute migraine treatment.
