Currently Enrolling Trials
Nurtec ODT is a calcitonin gene-related peptide receptor antagonist.
Nurtec ODT is specifically indicated for the acute treatment of migraine with or without aura in adults and for the preventive treatment of episodic migraine in adults.
Nurtec ODT is supplied as a tablet for sublingual or oral administration. The recommended dose is 75 mg taken orally. The maximum dose in a 24-hour period is 75 mg. The safety of treating more than 15 migraines in a 30-day period has not been established.
Mechanism of Action
Nurtec ODT (rimegepant) is a calcitonin gene-related peptide (CGRP) receptor antagonist. The activity of the neuropeptide CGRP is thought to play a causal role in migraine pathophysiology. Nuretc ODT works by reversibly blocking CGRP receptors, thereby inhibiting the biologic activity of the CGRP neuropeptide.
The most frequent adverse events associated with the use of Nurtec ODT was nausea.
Clinical Trial Results
The FDA approval of Nurtec ODT is based on results from the pivotal Phase 3 clinical trial (Study 303) and a long-term, open-label safety study (Study 201).
In the Phase 3 trial, Nurtec ODT achieved statistical significance on the regulatory co-primary endpoints of pain freedom and freedom from most bothersome symptom (MBS) at two hours post dose compared to placebo. Nurtec ODT also demonstrated statistical superiority at one hour for pain relief (reduction of moderate or severe pain to no pain or mild pain) and return to normal function. The benefits of pain freedom, pain relief, return to normal function and freedom from MBS were sustained up to 48 hours for many patients. These benefits were seen with only a single dose of Nurtec ODT. Eighty-six percent of patients treated with Nurtec ODT did not require rescue medication within 24 hours post dose.
The long-term safety study assessed the safety and tolerability of rimegepant with multiple doses used over up to one year. The study evaluated 1,798 patients, who used rimegepant 75 mg as needed to treat migraine attacks, up to one dose per day. The study included 1,131 patients who were exposed to rimegepant for at least six months, and 863 who were exposed for at least one year, all of whom treated an average of at least two migraine attacks per month. The safety of treating more than 15 migraines in a 30-day period has not been established.
The FDA approval of Nurtec for the preventative treatment was based on a double-blind, randomized, placebo-controlled Phase 3 clinical trial with an open label extension. Primary study endpoint results demonstrated that Nurtec was superior to placebo, decreasing monthly migraine days by 4.3 days/month after three months of treatment. The preventive effects of Nurtec were seen as early as the first week of therapy. Further, a key secondary endpoint result showed that approximately half of Nurtec-treated patients had a 50% or greater reduction in the number of moderate-to-severe migraine days per month.