Rimegepant offers relief from migraine in phase 3 trial

  • Lipton RB & al.
  • N Engl J Med
  • 11/07/2019

  • Susan London
  • Clinical Essentials
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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

  • Multicenter phase 3 randomized controlled trial among 1186 adults with ≥1-year history of migraine and 2-8 migraine attacks of moderate or severe intensity per month.
  • Randomization: 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.