Allergan Says ACHIEVE 1 Phase 3 Study For Ubrogepant Meets Co-primary Endpoints

(RTTNews) - Allergan plc (AGN) on Tuesday announced positive results from ACHIEVE I (UBR-MD-01), the first of two pivotal phase 3 clinical trials for evaluating the efficacy, safety and tolerability of orally administered ubrogepant 50 mg and ubrogepant 100 mg compared to placebo in a single migraine attack in adults.

The study met the co-primary endpoints in first of two Phase 3 studies. Allergan noted that co-primary endpoints were met for each Ubrogepant dose compared to placebo.

The ACHIEVE I study included 1,327 U.S. adult patients randomized (1:1:1) to placebo, ubrogepant 50 mg and 100 mg respectively, who were treated for a single migraine attack of moderate to severe headache intensity.

Allergan noted that both doses showed a statistically significant greater percentage of ubrogepant patients achieving pain freedom at 2 hours after the initial dose as compared to placebo patients.

In addition, a statistically significant greater percentage of ubrogepant patients achieved absence of the most bothersome migraine-associated symptom at 2 hours after the initial dose as compared to placebo patients.

"We are pleased with the favorable results of our ACHIEVE I study, which support the efficacy, safety, and tolerability profile of ubrogepant. We are confident that ubrogepant, an oral calcitonin gene-related peptide (CGRP) receptor antagonist will be an option for the treatment of migraines in adults," said David Nicholson, Chief Research and Development Officer of Allergan.

Allergan anticipates that additional results from this study will be released at upcoming scientific meetings throughout 2018.

Results of the second phase 3 trial, ACHIEVE II (UBR-MD-02), are expected in the 1st half of 2018. Allergan anticipates filing of a New Drug Application or NDA to the FDA in 2019.