- 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.
- 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.
- 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).
- 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.
- Lack of an active comparator.
Coauthored with Antara Ghosh, PhD