FDA approves Nurtec ODT to treat acute migraine. - Biohaven

Biohaven Pharmaceutical Holding Company Ltd. announced that the FDA has approved Nurtec ODT (rimegepant) for the acute treatment of migraine in adults. Nurtec ODT is the first FDA-approved product for Biohaven, a company dedicated to advancing innovative therapies for neurological diseases.A single quick-dissolving tablet of Nurtec ODT can provide fast pain relief and return patients to normal function within one hour, and deliver sustained efficacy that lasts up to 48 hours for many patients. Nurtec ODT disperses almost instantly in a person's mouth without the need for water, offering people with migraine a convenient, discreet way to take their medication anytime and anywhere they need it. Nurtec ODT is not indicated for the preventive treatment of migraine. Biohaven expects topline results from its prevention of migraine trial later this quarter. The FDA approval of Nurtec ODT is based on results from the pivotal Phase III clinical trial (Study 303) and the long-term, open-label safety study (Study 201). In the Phase III 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. Importantly, 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 (e.g. NSAIDS, acetaminophen) 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.