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.
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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