Rimegepant Zydis® Orally Dissolving Tablets (ODTs) may provide fast relief from acute migraine-associated pain, according to results of the third pivotal phase 3 trial announced in a company press release.
For this randomized placebo-controlled study (Clinicaltrials.gov identifier: NCT03461757), individuals with acute migraine (with or without aura) for ≥1 year were asked to take a single 75 mg dose of rimegepant, an antagonist to the calcitonin gene-regulated peptide (CGRP) receptor, (n=669) or placebo (n=682) when experiencing migraine of moderate to severe intensity.
The study’s primary outcomes were freedom from pain and freedom from the most bothersome symptom (ie, phonophobia, photophobia, or nausea), 2 hours after administration for both.
Two hours after dose intake, a greater percentage of study participants treated with rimegepant vs placebo were found to experience relief from pain (21.2% vs 10.9%, respectively; P <.0001), and from their most bothersome symptom (35.1% vs 26.8%, respectively; P =.0009).
Pain relief in patients treated with rimegepant vs placebo was reported as early as 15 minutes post-intake, and showed statistical significance starting 1 hour post-administration (P <.0001). Rimegepant-associated benefits, including freedom from pain, freedom from the most bothersome symptom, analgesia, and freedom from functional disability were maintained for at least 48 hours after intake of a single tablet (P <.0001, P =0.0018, P <.0001, and P <.0001, respectively).
In addition, return to “normal functioning” was reported by participants, 1 hour after taking rimegepant vs placebo (P =.0025). Of study participants administered rimegepant, 85% did not request rescue medication.
Rimegepant ODTs also indicated adequate safety profiles (pooled data from the 3 phase 3 trials: rimegepant, n=1771; placebo, n=1785), with no single adverse event occurring at a rate >1.6%, a pooled liver function comparable with that in the placebo group (above normal range alanine- or aspartate aminotransferase levels: rimegepant, 2.7%; placebo, 2.9%), and the absence of participants with elevated levels of bilirubin. Adverse events reported included nausea (rimegepant, 1.5%; placebo, 0.8%), and urinary tract infection (rimegepant, 1.2%; placebo, 0.7%). Serious adverse events were reported by 0.2% of patients in each group.
“These results, combined with the previous data from the two prior Phase 3 trials, reinforce the potential of rimegepant to be an important new and differentiated option for the acute treatment of migraine,” noted Vlad Coric, MD, chief executive officer of Biohaven.
Biohaven Pharmaceutical Holding Company Ltd. press release. Biohaven delivers positive phase 3 results with Rimegepant Zydis® Orally Dissolving Tablet (ODT): Rapid and lasting benefit for the acute treatment of migraine.