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
Related News:- Axsome Therapeutics Reports Data from P-III (ACCORD-2 & ADVANCE-2) Trials of AXS-05 in Alzheimer’s Disease Agitation
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