Migraine: orally dissolving rimegepant offers rapid relief in phase 3 trial

  • Lancet

  • Kelli Whitlock Burton
  • Clinical Essentials
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Takeaway

  • Patients with acute migraine reported a greater decrease in moderate or severe pain and other symptoms within 2 hours of receiving orally disintegrating rimegepant compared with placebo.

Why this matters

  • Some patients with migraine are unable to use commonly available treatments, and about one-third of those with no restrictions are dissatisfied with their current regimen.
  • The 2-hour speed of onset could be an advantage if approved by the FDA.
  • Data from a similar phase 3 trial were recently published.

Study design

  • Randomized, placebo-controlled, multicenter phase study of 1466 participants with migraine randomly assigned to rimegepant (75 mg orally disintegrating tablet) or placebo. 
  • Funding: Biohaven Pharmaceuticals.

Key results

  • At 2 hours, orally disintegrating rimegepant vs placebo was associated with significant freedom from:
    • moderate and severe pain (21% vs 11%; P<.0001>
    • most bothersome pain (35% vs 27%; P=.0009). 
  • Rimegepant was superior in terms of:
    • pain relief and ability to function normally at 60 minutes,
    • freedom from pain and freedom from most bothersome symptoms at 90 minutes,
    • rescue medication use at 24 hours, and
    • sustained freedom from pain and pain relief from 2 to 48 hours.
  • The most common adverse events in both groups were nausea, urinary tract infection, and dizziness.

Limitations

  • Lack of an active comparator.

Coauthored with Antara Ghosh, PhD