Long-Term Safety and Tolerability of Rimegepant for Treatment of Migraine


Initial results from an ongoing, open-label safety study of the oral calcitonin gene-related peptide (CGRP) receptor antagonist, rimegepant, show that the drug may be effective and safe for acute treatment of migraine.  

Rimegepant (formerly known as BHV-3000; Biohaven, New Haven, CT) is an orally available, selective, and potent small molecule CGRP receptor antagonist. Study BHV3000-201 (NCT03266588) is a multicenter trial with 1,780 US adult patients. Eligible patients have a history of 2 to 14 migraine attacks of moderate-to-severe intensity per month. 

In this interim study, patients treat migraine attacks of all severities up to once daily for up to a full year with 75 mg of rimegepant. After 12 weeks of treatment, about 40% of patients who had more than 15 headache days/month showed a 30% or more reduction in their number of headache days.  

The interim results also include hepatic safety and tolerability data of rimegepant based upon adverse events and regularly scheduled liver function tests. The data were reviewed by an independent panel of liver experts which concluded that no liver safety signal was detected.  

"This interim safety analysis is important because it provides additional long-term evidence on the safety of oral CGRP receptor antagonists,” said Richard Lipton, MD. “Furthermore, the early efficacy observations from this trial suggesting a reduction in monthly migraine days support the potential of rimegepant in the preventive treatment of migraine.”  


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