Rimegepant Provides Freedom From Pain and Other Symptoms in Phase 3 Clinical Trials
Expanded data from 2 randomized, pivotal phase 3 clinical trials of rimegepant (Biohaven, New Haven, CT), a small molecule calcitonin gene-related peptide (CGRP) receptor antagonist was presented that supports the potential for rimegepant to provide persons with migraine an acute single-dose treatment that provides both freedom from pain and freedom from what they judge as their own most bothersome migraine-associated symptom.
In contrast to currently available triptan medications, rimegepant has no active vasoconstrictive properties, and persons with migraine who have cardiovascular contraindications to triptans may benefit from this.
“The two acute treatment Phase 3 clinical trials demonstrate that a single dose of rimegepant can relieve pain and restores function for people with migraine," said Richard B. Lipton, MD, Professor and Vice Chair of Neurology and Director of the Montefiore Headache Center at the Albert Einstein College of Medicine, and Chair of Biohaven’s CGRP Scientific Advisory Board. “Most importantly, rimegepant has the potential to help millions of people with migraine get back to work and back to their families.”
In the 2 completed pivotal phase 3 trials of rimegepant, 1,162 and 1,186 patients were randomized to receive a single dose of rimegepant or placebo. A wide range of clinically meaningful benefits were seen in subjects given rimegepant versus those given placebo, including photophobia, phonophobia, and nausea in addition to overall freedom from pain. Improvements in symptoms that subjects experienced were durable both in terms of sustained freedom from pain and from the most bothersome symptom from 2 to 24 hours and from 2 to 48 hours, respectively. Meaningful gains were seen as early as 2 hours post dose for both pain relief and freedom from functional disability. Subjects given rimegepant had low use of rescue medications.
Rimegepant was generally well tolerated, with the most frequent adverse event, nausea, occurring in only 1.4% of subects treated with rimegepant, as compared to 1.1% of patients given placebo. Additionally, rimegepant demonstrated a liver safety profile similar to placebo.