Rimegepant Orally Dissolving Formulation Provides Rapid Relief From Acute Migraine

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.

Follow @ClinicalPainAdv

Reference

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.