PHILADELPHIA — More patients with migraine who received the investigational oral drug rimegepant were free from pain and their “most bothersome symptom” vs. patients who received placebo, according to study results presented at the American Headache Society Annual Scientific Meeting and published simultaneously in The New England Journal of Medicine.
Rimegepant (Biohaven) is a pill belonging to the calcitonin gene-related peptide class of medications intended to treat migraine-related pain, according to a press release. Previously FDA-approved CGRP agents — Aimovig (erenumab-aaoe; Amgen, Novartis), Ajovy (fremanezumab-vrfm, Teva) and Emgality (galcanezumab-gnlm, Lilly) — are all intended to prevent migraine and are all injections.
In the new study, Richard Lipton, MD, director of the Montefiore Headache Center, and colleagues, randomly assigned 1,186 patients (mean age, 40.6 years; 88.7% women) with migraine for at least 1 year and who experienced two to eight migraine attacks of moderate or severe intensity per month in an approximate 1:1 ratio to receive either 75 mg of rimegepant or placebo. Upon migraine onset, patients were instructed to record their migraine symptoms and level of pain, take the pill and then assess their pain at various intervals up to 48 hours after the tablet was first consumed.
More patients with migraine who received the investigational oral drug rimegepant were free from pain and their “most bothersome symptom” vs. patients who received placebo, according to study results presented at the American Headache Society Annual Scientific Meeting and published simultaneously in The New England Journal of Medicine.
Lipton and colleagues found that 19.6% of patients in the rimegepant cohort were pain-free after 2 hours vs. 12% in the placebo group (absolute difference, 7.6 percentage points; 95% CI, 3.3-11.9). The percentage of patients who were free from their most bothersome symptom other than pain 2 hours after the dose was 37.6% in the rimegepant cohort and 25.2% in the placebo group (absolute difference, 12.4 percentage points; 95% CI, 6.9-17.9). The most common adverse events were urinary tract infection and nausea, according to researchers.
“For the first time in nearly 3 decades, people with migraine not helped by existing medications may have a new option to find relief during attacks,” Lipton said in the press release. “As someone who has studied CGRP blockers for more than a decade, I'm gratified to see their benefits confirmed in a large-scale clinical trial.”
Rimegepant is awaiting FDA approval, according to the press release. – by Janel Miller
Lipton R, et al. N Engl J Med 2019;doi:10.1056/NEJMoa1811090.
Disclosures: Lipton reports being a paid consultant and a stockholder of Biohaven. Please see the study for all other authors’ relevant financial disclosures.