Axsome Therapeutics Receives the US FDA Approval for Symbravo (meloxicam and rizatriptan) to Treat Migraine

Shots:

• The US FDA has approved Symbravo for acute treatment of migraine with/without aura in adults based on P-III (MOMENTUM), P-III (INTERCEPT) & P-III (MOVEMENT) trial; commercially available in ~4mons.
• MOMENTUM trial assessed Symbravo (single dose) vs PBO/meloxicam/rizatriptan, showing greater pain & symptoms freedom (photophobia, phonophobia & nausea) at 2hrs., sustained through 24-48hrs., 77% pts don’t require rescue therapy within 24hrs. of dosing compared to rizatriptan from 2-24hrs.
• INTERCEPT trial also showed similar results, with 85% pts not requiring rescue therapy within 24hrs., while MOVEMENT trial showed its long-term safety in 706 pts, dosed intermittently for ~12mos. & treating ~2 migraines/mos.

Ref: Globenewswire | Image: Axsome Therapeutics

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