Axsome receives FDA approval for SYMBRAVO (meloxicam/rizatriptan) for acute migraine in adults

Axsome Therapeutics, Inc.

SYMBRAVO approved by FDA for acute treatment of migraine; expected commercially available in ~4 months.
In MOMENTUM trial, 77% of patients did not require rescue medication within 24h; superior to rizatriptan on sustained pain freedom.
In INTERCEPT trial (mild pain), 85% of patients did not require rescue medication within 24h; pain freedom sustained through 24-48h.
Most common adverse reactions: somnolence and dizziness (2% vs 1%). Long-term safety from MOVEMENT trial over 12 months.
Patented MoSEIC technology provides 5x faster meloxicam absorption; patent protection through at least 2040.

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