The FDA has approved a combination of meloxicam and rizatriptan (Symbravo, Axsome Therapeutics) for the acute treatment of migraine with or without aura in adults.
The approval is based on the results of the phase 3 MOMENTUM trial that treated migraine of moderate and severe pain intensity; the phase 3 INTERCEPT trial that treated migraine when the initial pain was mild; and the phase 3 MOVEMENT long-term, open-label safety trial. A total of more than 21,000 migraine attacks were treated