Allergan announced that the Food and Drug Administration (FDA) has accepted for review the New Drug Application for ubrogepant, a highly potent oral calcitonin gene-related peptide (CGRP) receptor antagonist, for the acute treatment of migraine in adults.

The NDA submission included data from the ACHIEVE I and ACHIEVE II studies, as well as 2 other safety studies (UBR-MD-04 and 3110-105-002). In these clinical trials, ubrogepant was found to be safe and effective in the acute treatment of migraine in a wide range of patients, including those who had an insufficient response to a triptan or those in whom triptans were contraindicated, as well as in patients who had moderate to severe cardiovascular risk.

In ACHIEVE I (N=1327), patients were randomized to receive ubrogepant 50mg, 100mg, or placebo for the treatment of a single migraine attack of moderate to severe headache intensity. The co-primary endpoints were pain freedom 2 hours after initial dose and absence of most bothersome symptom 2 hours after initial dose. Two hours after a migraine attack, 19.2% and 21.2% of patients in the ubrogepant 50mg and 100mg groups were pain free, respectively, compared to 11.8% of placebo-treated patients. A greater percentage of ubrogepant patients achieved absence of the most bothersome migraine-associated symptom at 2 hours after the initial dose compared to placebo patients.

In ACHIEVE II (N=1355), patients with a history of migraine (with or without aura) were randomized to receive placebo, ubrogepant 25mg or 50mg, respectively, to treat a single migraine attack of moderate-to-severe intensity. Compared with placebo, a statistically significantly greater percentage of patients treated with ubrogepant 50mg achieved pain freedom 2 hours after administration and absence of the most bothersome symptom 2 hours after initial dose (the study’s co-primary endpoints).

A Prescription Drug User Fee Act (PDUFA) target date for the ubrogepant NDA has been set for the 4th quarter of 2019.

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The FDA recently approved several injectable CGRP receptor antagonist therapies for the prophylaxis of migraine, including erenumab, fremanezumab, and galcanezumab; ubrogepant would be the first oral CGRP receptor antagonist for acute treatment.

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