Biohaven Pharmaceutical has reported that a single dose of its rimegepant drug has led to reduced pain in a pivotal Phase III clinical trial involving migraine patients.
Rimegepant is a calcitonin gene-related peptide (CGRP) antagonist intended for the acute and preventive treatment of the condition.
The Phase III trial compared a 75mg of the drug to placebo in 1,186 patients.
Data revealed superior and rapid pain freedom, as well as relief from the worst migraine-associated symptom at two hours after dosing with rimegepant, compared to placebo.
In the study drug arm, 19.6% of patients were free from pain versus 12% in the placebo group. The figures for relief from the worst symptoms were 37.6% versus 25.2% respectively.
The study drug was also observed to be significantly higher in terms of sustained pain freedom and pain relief through 48 hours and the ability to return to function at two hours.
Rimegepant was generally well tolerated and exhibited a low incidence of side effects.
The most frequent adverse events found during the trial were nausea in 1.8% of subjects on study drug compared to 1.1% of those on placebo, and urinary tract infection (UTI) in 1.5% and 1.1% of the patients respectively.
Biohaven Pharmaceutical CGRP scientific advisory board chair Richard Lipton said: “The results from this study demonstrate rimegepant’s potential as an effective treatment for migraine, a widespread, disabling disease that has seen only minimal improvements in acute treatment since the 1990s.”
Study results have been published in the New England Journal of Medicine.
Rimegepant has been validated in three pivotal Phase III trials and a Phase IIb trial. The company has already submitted a new drug application (NDA) to the US Food and Drug Administration (FDA).