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Nurtec ODT is the first oral CGRP antagonist approved for migraine prevention, says its maker, Biohaven.
Rimegepant (Nurtec ODT, Biohaven), the migraine medication, is now wearing two hats as both a preventive and treatment migraine drug.
The FDA had previously approved Nurtec ODT for acute treatment in all eligible adult patients with migraine.
The new indication — cleared by FDA in late May — for preventive treatment in adult patients with less than 15 headaches days per month expands the potential preventive use of the drug to cover around 95% of individuals with migraine, Biohaven, a New Haven, Connecticut, biotech company, said in a press release.
"I've been practicing medicine for 25 years, and this is the first time we have a single migraine medication that can do both of these things," Biohaven CEO Vlad Coric, M.D., said on CNBC’s “Mad Money. "This is going to change the paradigm in which migraine is treated.”
The approved product label was also expanded to include the use of Nurtec ODT 75 mg up to 18 doses per month, allowing for both acute and preventive therapy in the same patient.
“This new approval makes Nurtec ODT the first oral CGRP [calcitonin gene-related peptide receptor] antagonist approved for the preventive treatment of migraine, and the only migraine medication approved as a dual therapy for both the acute and preventive treatment,” Biohaven said in its press release.
Nurtec ODT’s approval is based on a double-blind, randomized, placebo-controlled Phase 3 clinical trial that demonstrated that the drug decreased monthly migraine days by 4.3 days per month after 3 months versus placebo. The preventive effects of Nurtec were seen as early as the first week of therapy.
In addition, around half of Nurtec ODT-treated patients had a 50% or greater reduction in the number of moderate-to-severe migraine days per month.