FDA Greenlights Symbravo for Acute Treatment of Migraine: Daily Dose

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Last week, we reported on on the US FDA approval of Symbravo (meloxicam and rizatriptan, Axsome Therapeutics) for the acute treatment of migraine, with or without aura.

The approval

Symbravo is a novel oral multimechanistic medication that combines the rapidly absorbed COX-2 preferential NSAID meloxicam and the 5-HT1 receptor agonist rizatriptan, considered one of the acute migraine therapies with the fastest onset of action. Symbravo is designed to provide rapid, enhanced and consistent relief of migraine, with reduced symptom recurrence.

In clinical trials, the NSAID/triptan combination resulted in efficacy sustained through 24 and 48 hours in some patients after a single dose. Across the phase 3 development program, the novel medication’s efficacy was shown over a broad range of migraine scenarios including at the earliest onset of pain, in adults with moderate to severe pain, and in those with a history of variable response to prior acute treatments.

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