The director of the Montefiore Headache Center provided insight on an open-label study presented at AHS 2022 that highlighted rimegepant’s (Nurtec ODT; Biohaven) impact both as a preventative and acute medication. [WATCH TIME: 5 minutes]
WATCH TIME: 5 minutes
"This study showed that in open-label, naturalistic, real-world settings, when people are given the opportunity to use rimegepant as both a preventive and acute treatment, they do it. They don’t take rimegepant very often even when the drug is freely available, and that the safety and tolerability, as well as the long-term efficacy data, are encouraging."
After first receiving approval in February 2020 for the acute treatment of migraine, Biohaven’s oral calcitonin gene-related peptide (CGRP) antagonist rimegepant altered the treatment paradigm when it received an expanded indication in May 2021 as a preventive medication. Known as the first approved therapeutic approved for both acute and preventive use, the orally disintegrating tablet continued to prove its safety and efficacy in an open-label extension of a phase 2/3 randomized, placebo-controlled study (NCT03732638) presented at the 2022 American Headache Society (AHS) Annual Meeting, June 9-12, in Denver, Colorado.1
In the study, participants who completed 12 weeks of double-blind treatment with rimegepant 75 mg or placebo every other day (EOD) could continue with rimegepant 75-mg EOD for the preventive treatment of migraine for 52 weeks. On nonscheduled dosing days, individuals were allowed to take rimegepant 75 mg up to once per day on an as-needed (PRN) basis for acute treatment of their condition. Of the 741 subjects treated in the double-blind phase, 603 (81.4%) continued treatment in the open-label extension.
At the 1-year period of the open-label extension, rimegepant 75-mg EOD for preventive treatment plus PRN on nonscheduled dosing days for acute treatment was shown to be safe and well tolerated with no liver safety concerns. Lead investigator Richard B. Lipton, MD, director of the Montefiore Headache Center, sat down with NeurologyLive® at AHS 2022 to discuss the findings in greater detail, as well as why they hold such significance for both the patient and clinician community.