FDA Approves Symbravo: A New Hope for Migraine Relief

The U.S. Food and Drug Administration (FDA) has granted approval for Symbravo, a groundbreaking treatment that combines rizatriptan and meloxicam, designed for the acute management of migraines in adults. This innovative formulation aims to address the needs of the over 39 million Americans suffering from this debilitating condition. Symbravo is expected to hit the market within the next four months.

Clinical trials have shown promising results for Symbravo. Over 21,000 migraine attacks were treated using the rizatriptan/meloxicam combination during the studies. A single oral dose of Symbravo delivered relief for a significant number of patients, allowing most to avoid additional rescue medication within the following 24 hours. The approval stems from three comprehensive phase 3 clinical trials: MOMENTUM, INTERCEPT, and MOVEMENT.

The MOMENTUM trial focused on adults experiencing moderate to severe migraine pain, while the INTERCEPT trial addressed early-onset migraines with mild initial pain. The MOVEMENT trial served as a long-term open-label safety assessment. Richard B. Lipton, MD, director of the Montefiore Headache Center, emphasized the significance of this new treatment.

“The approval of Symbravo is a long awaited and much welcomed advancement for clinicians and our patients, providing a new, meaningful treatment option,” – Richard B. Lipton, MD.

According to Lipton, a substantial number of migraine sufferers encounter insufficient relief with existing acute treatments. This inadequacy can exacerbate their suffering and increase the frequency of migraine episodes. He added that Symbravo's rapid absorption technology and its ability to target multiple pathways involved in migraine attacks set it apart from previous options.

“Symbravo incorporates Axsome’s rapid absorption technology and mechanisms that target multiple migraine attack pathways,” – Axome Therapeutics.

With migraine being the leading cause of disability among neurological disorders in the United States, the need for effective treatments remains critical. Lipton noted that Symbravo provides both rapid and sustained relief from migraine pain, whether patients take the treatment at the onset of an attack or later when pain intensifies.