Rimegepant offers relief from migraine in phase 3 trial

Takeaway

• Rimegepant, an investigational oral calcitonin gene-related peptide receptor antagonist, is safe and efficacious for treating migraine attacks.

Why this matters

• Triptans have limited efficacy, adverse effects, safety concerns in patients with cardiovascular disease.

Key results

• Compared with placebo group, rimegepant group more likely to be free at 2 hours from:
  • Pain (19.6% vs 12.0%; absolute difference, 7.6 percentage points; P<.001).
  • Most bothersome nonpain symptom (37.6% vs 25.2%; absolute difference, 12.4 percentage points; P<.001).
• No difference in freedom from nausea at 2 hours (48.1% vs 43.3%; P=.21).
• Leading adverse events with both rimegepant and placebo were nausea (1.8% vs 1.1%) and urinary tract infection (1.5% vs 1.1%).
• Serious adverse events occurred in 0.2% of rimegepant group (back pain) and 0.4% of placebo group (chest pain, urinary tract infection).

Study design

• Multicentre phase 3 randomised controlled trial among 1186 adults with ≥1-year history of migraine and 2-8 migraine attacks of moderate or severe intensity per month.
• Randomisation: double-blind oral rimegepant vs placebo for single migraine attack.
• Main outcomes: freedom from pain, freedom from most bothersome nonpain symptom at 2 hours after dose.
• Funding: Biohaven Pharmaceuticals.

Limitations

• Smaller, shorter-duration trial.
• Lack of an active comparator.
• Uncertain safety in patients having cardiovascular disease.