Long-term Use of Rimegepant 75 mg for the Acute Treatment of Migraine Reduces Use of Analgesics and Antiemetics
David Kudrow1, Kathleen Mullin2, Gary Berman3, Richard Lipton4, Christopher Jensen5, Alexandra Thiry5, Meghan Lovegren5, Charles Conway5, Vlad Coric5, Robert Croop5
1David Kudrow MD, 2New England Institute for Neurology & Headache, 3Clinical Research Institute, 4Albert Einstein College of Medicine, 5Biohaven Pharmaceuticals
Objective:

To determine if acute treatment with rimegepant over time reduces the use of analgesics or antiemetics in adults with migraine.

Background:

Although over-the-counter and prescription analgesics and antiemetics are widely used for the acute treatment of migraine, they can be inadequate for severe attacks and have potential safety issues. Rimegepant, an FDA-approved, orally administered small molecule CGRP receptor antagonist, may reduce analgesic and/or antiemetic use during long-term treatment.

Design/Methods:

This long-term, open-label safety study (NCT03266588) included adults with a history of 2-14 monthly migraine attacks of moderate to severe pain intensity. Two dosing regimens of rimegepant 75 mg up to once daily were evaluated: (1) as needed (PRN) for 52 weeks to treat attacks of any pain intensity; and (2) every other day plus PRN (EOD+PRN) for 12 weeks. In this post-hoc analysis, use of OTC or prescription analgesics and antiemetics was analyzed during the 30-day observation period and over time in the rimegepant long-term treatment period.

Results:

Of the 1800 subjects treated (PRN [n=1514], EOD+PRN [n=286]), 89.4% were female, and mean age was 43 years. The most commonly used analgesics were ibuprofen, fixed combination acetaminophen/aspirin/caffeine, acetaminophen, and naproxen (select analgesics). The most commonly used antiemetics were ondansetron, promethazine, dimenhydrinate, meclizine, and prochlorperazine (select antiemetics). Of those who remained on study, the percentage of subjects (95% CI) who did not use select analgesics or antiemetics increased over time from 19.9% (18.2-21.9; n=1800) during the observation period to 44.6% (42.3-46.9; n=1800) during Weeks 1-4 of rimegepant treatment, 58.3% (55.9-60.6; n=1725) during Weeks 5-8, and 61.6% (59.2-63.9; n=1645) during Weeks 9-12. In the PRN group, 67.6% (64.6-70.5; n=972) of subjects did not use these medications during Weeks 49-52.

Conclusions:

Rimegepant 75 mg up to once daily for the acute treatment of migraine substantially reduced the use of analgesics and antiemetics in adults with migraine.