Results From Phase 3 Trial of Migraine Tx Ubrogepant Released
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.
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.
For more information visit Allergan.com.