In acute, moderate-to-severe migraine attacks, rimegepant led to a safe and effective reduction in pain and symptoms within 2 hours. These effects were also sustained over the next 1 to 2 days. These are the findings of a study published in the Lancet Neurology.
Rimegepant is an orally dissolving, small molecule agent that targets calcitonin gene-related peptide receptors to treat acute migraines. While available in the United States, the United Kingdom, and Europe, rimegepant has not been approved for use among adults with migraine living in China or South Korea.
Researchers conducted a double-blind, randomized, placebo-controlled, multicenter, phase 3 trial at 86 outpatient centers across China and South Korea from October 22, 2020 and October 8, 2021. They enrolled adults aged 18 years and older with a medical history of migraine for at least 1-year with fewer than 15 migraine attacks per month and between 2 to 8 moderate-to-severe attacks per month.
The researchers randomly assigned 716 participants to the treatment group and 715 participants to the placebo group. The treatment group received a 75 mg dissolvable rimegepant tablet to treat a single moderate-to-severe migraine attack.
Only 668 individuals in the treatment group used the treatment and 674 individuals in the placebo group used the placebo. The researchers only included 1,340 participants — 666 in the rimegepant group and 674 in the placebo group — in the final analysis.
Most of the participants were women (81%) from China (80%) with a median age of 37.8 and a median number of 3.3 moderate-to-severe migraine attacks per month. Most participants reported that their most bothersome migraine symptom was nausea (54%) followed by phonophobia (27%) and photophobia (19%).
Outcome measures included pain freedom and freedom from the most bothersome, historical migraine symptom for each participant 2 hours following dosing. The researchers also analyzed adverse events that occurred in both groups.
After 2 hours following dosing, 132 (20%) out of the 666 patients who took rimegepant reported freedom from pain compared with only 74 (11%) out of 674 in the placebo group (risk difference, 9.2%; 95% CI 5.4-13.0; P <.0001). Rimegepant also proved more efficacious than placebo in achieving sustained pain freedom up to 24 and 48 hours after the initial dose.
Additionally, 336 (50%) out of the 666 people with migraine who took rimegepant also reported freedom from their most bothersome historical migraine symptom, compared with 241 (36%) out of 674 people in the placebo group (risk difference, 14.8%; 95% CI 9.6-20.0; P <.0001).
The most commonly reported adverse events included proteinuria, nausea, and urinary tract infection. No serious adverse events — including drug-related liver injury — occurred that were related to the rimegepant treatment. In the treatment group, 92 (14%) participants reported mild treatment-related adverse events, compared with 96 (14%) participants.
“Rimegepant 75 mg was shown to be effective — with rapid relief of pain and return to normal function and excellent safety and tolerability — for the acute treatment of migraine in adults living in China and South Korea,” the researchers noted. “Because no CGRP [calcitonin gene-related peptide] antagonists have been approved in China or South Korea for acute treatment, the results of this clinical trial suggest that the rimegepant 75 mg orally disintegrating tablet might be a useful addition to the range of medications for the acute treatment of migraine in these countries.”
Study limitations included lack of assessment of consistency of treatment effects over time or medium- or long-term adverse effects, lack of comparison to existing antimigraine medications, and COVID-19 pandemic restrictions and limitations.
Disclosures: Several study authors declared affiliations with biotech, pharmaceutical, and/or device companies. Please see original source for full list of disclosures.
Yu S, Kim BK, Guo A, et al. Safety and efficacy of rimegepant orally disintegrating tablet for the acute treatment of migraine in China and South Korea: a phase 3, double-blind, randomised, placebo-controlled trial. Lancet Neurol. 2023;22(6):476-484. doi:10.1016/S1474-4422(23)00126-6