Allergan announced results from the second Phase 3 trial for their novel acute migraine treatment, ubrogepant, a calcitonin gene-related peptide (CGRP) receptor antagonist.

In the ACHIEVE II (UBR-MD-02) trial, 1355 patients with a history of migraine (with or without aura) were randomized (1:1:1) to receive placebo, ubrogepant 25mg or 50mg, respectively, to treat a single migraine attack of moderate-to-severe intensity. The co-primary endpoints were pain freedom 2 hours after administration and absence of the most bothersome symptom 2 hours after initial dose.  

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Results showed that 14.3%, 20.7% (P=.0285), and 21.8% (P=.0129) of patients achieved pain freedom in the placebo, ubrogepant 25mg dose, and 50mg dose groups, respectively. The second co-primary endpoint, absence of most bothersome symptom, was achieved by 27.4%, 34.1% (P=.0711), and 38.9% (P=.0129) of patients in the placebo, ubrogepant 25mg, and 50mg groups, respectively; the ubrogepant 25mg group did not achieve statistical significance for this endpoint. 

The 50mg dose was also associated with a statistically significant greater percentage of patients achieving pain relief at 2 hours, sustained pain relief from 2 to 24 hours, and sustained pain freedom from 2 to 24 hours after the initial dose vs placebo (50mg vs placebo, P=.0129 for each endpoints).  In addition, a statistically significant greater percentage of patients treated with ubrogepant 50mg achieved absence of photophobia (P=.0167) and phonophobia (P=.0440).

“Given the prevalence of migraine and significant disability that many patients face, ubrogepant may provide a new option for those having tolerability issues with current migraine-specific treatments,” said Dr. Stephen Silberstein, Director, Headache Center, Thomas Jefferson University.

Additional results from the ACHIEVE II trial will be reported at upcoming scientific meetings. 

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