Posted by The U.S. Food and Drug Administration has approved Axsome Therapeutics’ new migraine treatment tablet on 30 January 2025 [1].
Marketed under the brand name Symbravo®, the oral medication is intended for the acute treatment of migraines, a condition marked by recurrent episodes of moderate to severe throbbing pain, typically affecting one side of the head.
Symbravo® combines two active ingredients: meloxicam and rizatriptan. The composition possesses rapid onset of action due to betadex sulfobutylether sodium (SBECD) amongst its formulation excipients to deliver both rapid and sustained relief from acute migraine pain. An artistic depiction of the mode of action, published by the developer, suggests that meloxicam is the compound which is present in an inclusion complex within the composition [2]. The company anticipates the drug will be available in the U.S. within approximately four months.
The approval was supported by two late-stage clinical trials demonstrating that Symbravo® significantly reduced migraine pain compared to a placebo. Further details including prescribing information may be found on the product’s own homepage [3].
[2] https://www.axsome.com/wp-content/themes/axsome/images/pipeline/axs-07-MOA-d.jpg
