Practical NeurologyThe FDA Approved a New Oral, As-Needed Tablet for Acute Migraine Treatment

Symbravo (meloxicam/rizatriptan) has received FDA approval for acute migraine treatment based on three Phase 3 trials (MOMENTUM, INTERCEPT, MOVEMENT). The dual-mechanism therapy combines a 5-HT1B/1D agonist with a COX-2 preferential NSAID, utilizing MoSEIC technology for enhanced meloxicam absorption.

Key Clinical Considerations:

• INTERCEPT trial (n=302) demonstrated superior 2-hour pain freedom (32.6% vs 16.3%, P=.002) and freedom from most bothersome symptoms (43.9% vs 26.7%, P=.003) compared to placebo
• MOMENTUM trial (n=1594) showed significant improvement in 2-hour pain freedom (19.9% vs 6.7%, P<.001) in patients with inadequate response to prior treatments
• 77-85% of treated patients did not require rescue medication within 24 hours across both efficacy trials
• MOVEMENT long-term safety study (n=706) identified dizziness and somnolence as most common adverse events
• Boxed Warning includes risks of serious cardiovascular and gastrointestinal events, requiring careful patient selection

HCN Medical Memo
Implementation requires balanced consideration of efficacy benefits against safety risks. Patient selection should account for cardiovascular and gastrointestinal risk factors. The as-needed oral formulation offers flexibility in treatment timing, with demonstrated efficacy in both early and late intervention during migraine attacks.

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