Allergan has reported positive results from its ACHIEVE II (UBR-MD-02) trial, which is the second of two pivotal Phase III clinical studies designed to analyse the efficacy, safety and tolerability of orally administered ubrogepant in comparison with placebo to treat single migraine attack.
The multi-centre, placebo-controlled trial investigated two doses of ubrogepant at 25mg and 50mg compared to placebo.
The trial enrolled around 1,686 adult patients in the US. They were randomised at a 1:1:1 ratio to receive placebo, ubrogepant 25mg and 50mg respectively, for the treatment of a single migraine attack with moderate-to-severe headache intensity.
Findings of the trial have revealed that in the modified ITT (mITT) population of 1,355 patients, both doses demonstrated a statistically significant greater percentage of ubrogepant patients achieving pain relief at two hours after the initial dose as compared to placebo patients.
Among the mITT population, the 50mg dose showed a statistically significant greater percentage of ubrogepant patients achieving absence of the most bothersome migraine-associated symptom.
The 25mg dose showed a similar improvement in the percentage of ubrogepant patients. The dose, however, failed to demonstrate statistical significance.
Among other results, the trial has revealed that the 50mg dose of ubrogepant showed a statistically improved percentage of patients achieving pain relief at two hours, sustained pain relief from two to 24 hours, and sustained pain freedom from two to 24 hours after the initial dose as compared to placebo.
The ACHIEVE II trial has also demonstrated ubrogepant to be well tolerated and having a safety profile similar to placebo.
“We are pleased to share these positive results from ACHIEVE II, our second Phase III study supporting the efficacy, safety, and tolerability of 50mg ubrogepant,” Allergan chief research and development officer David Nicholson said.
“The consistency in response between both ACHIEVE I and ACHIEVE II provides further evidence that ubrogepant, an oral calcitonin gene-related peptide (CGRP) receptor antagonist, offers a promising opportunity for the acute treatment of migraine.
Allergan expects to provide additional results from the study at upcoming scientific meetings to be held throughout the year.
The company also plans to file a new drug application (NDA) to the US Food and Drug Administration (FDA) next year.