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Biohaven Pharmaceutical announced that a single dose of its rimegepant drug had resulted in an absence of pain in a pivotal phase III clinical trial involving migraine patients.
Rimegepant is a calcitonin gene-related peptide (CGRP) antagonist for the acute and preventative treatment of the disease.
The Phase III trial compared 75 mg of the drug with placebo in 1,186 patients.
The data revealed a superior and rapid absence of pain, as well as the absence of the most troublesome symptom badociated with migraine two hours after the administration of rimegepant, compared with placebo.
In the study group of drugs, 19.6% of the patients were painless, compared to 12% in the placebo group. The figures for the absence of the most troublesome symptoms were respectively 37.6% and 25.2%.
It was also observed that the drug in the study was numerically superior in terms of continuous pain relief and pain relief after 48 hours and because of the ability to resume activity two hours later.
Rimegepant was generally well tolerated and had a low incidence of side effects.
The most common adverse events observed during the trial were nausea in 1.8% of subjects treated with the study drug, compared to 1.1% of those receiving placebo, and urinary tract infection in 1.5% and 1.1% of patients, respectively.
Richard Lipton, Chair of the Scientific Advisory Board of Biohaven Pharmaceutical's CGRP, said, "The results of this study demonstrate the potential of rimegepant as an effective treatment for migraine, a common debilitating disease that has only minimal improvements in short-term treatment since the 1990s. "
The results of the study were 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 to the US Food and Drug Administration (FDA).
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