Axsome Therapeutics, a biopharmaceutical company, has announced that SYMBRAVO (meloxicam and rizatriptan) is now available by prescription in the United States for the acute treatment of migraine with or without aura in adults.

SYMBRAVO represents a novel multi-mechanistic approach to treating migraine that targets multiple brain pathways underlying a migraine attack. SYMBRAVO rapidly provides migraine pain freedom and returns patients to normal functioning at 2 hours versus placebo, with lasting pain freedom sustained from 2 to 24 hours in some patients after a single dose.

Stewart J. Tepper, Vice President of the New England Institute for Neurology and Headache, said, “Many individuals living with migraine do not achieve adequate pain relief with currently available acute treatments. SYMBRAVO therefore provides a potentially valuable new treatment option as a rapid-acting and durable multi-mechanistic approach. Taken together with the demonstrated data showing effectiveness across a spectrum of migraine severities, I believe that SYMBRAVO offers potentially significant clinical benefits for patients, especially those reporting inadequate relief from migraine pain with their existing treatment program.”

Susan Lane Stone, CEO of the National Headache Foundation (NHF), commented, “The National Headache Foundation educational and advocacy programs encourage the over 40 million Americans (including 31.5 million women and 6.7 million members of the military community) to speak up about their own unique acute migraine journey. Many are still seeking solutions, as they have not yet found relief, so having a new FDA-approved option for the acute treatment of migraine will help address this significant unmet need. For over 50 years, the NHF has been a credible resource for the headache and migraine disorders community. NHF’s awareness and educational initiatives have focused on the recognition that head pain and other bothersome symptoms are very real daily challenges for each person living with migraine attacks.”

Ari Maizel, Chief Commercial Officer of Axsome, added, “We are very pleased to launch SYMBRAVO, powered by Axsome’s patented MoSEIC technology, and deliver a novel therapy to the millions of people living with migraine. At Axsome, we are intensely committed to improving the lives of patients. To ensure patient access to this important and distinct medicine, we are also providing comprehensive patient support, which includes a SYMBRAVO On My Side savings program for eligible patients as well as educational resources and tools.”

Migraine is a debilitating condition characterised by recurrent attacks of pulsating, often severe and disabling head pain, accompanied by nausea, sensitivity to light, and/or sensitivity to sound. Migraine affects approximately 40 million people in the US and according to the Global Burden of Disease study in 2019, is the second leading cause of all disability worldwide. A recent survey of more than 1700 migraine patients showed that 63 percent were not satisfied with their current treatment plan.

For patients, Axsome provides robust and comprehensive support services through the Symbravo On My Side program. The company’s Symbravo On My Side Savings Card reduces patient out-of-pocket costs for commercially insured eligible patients who qualify. Axsome’s Symbravo On My Side program provides patients with educational resources and tools for patients to facilitate discussions with their healthcare providers.