ACHIEVE II phase III trial of ubrogepant shows dose-dependent results in migraine.- Allergan.

Allergan announced positive results from ACHIEVE II (UBR-MD-02), the second of two pivotal Phase III clinical trials evaluating the efficacy, safety and tolerability of orally administered ubrogepant 25 mg and ubrogepant 50 mg compared to placebo in a single migraine attack in adults. Allergan anticipates filing of a New Drug Application (NDA) to the FDA in 2019. The ACHIEVE II study included 1,686 U.S. adult patients randomized (1:1:1) to placebo, ubrogepant 25 mg and 50 mg respectively, to treat a single migraine attack of moderate-to-severe headache intensity.

In the modified ITT (mITT) population of 1355 patients, 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 (25 mg vs placebo, p=0.0285, 50 mg vs placebo, p=0.0129) and the 50 mg dose demonstrated a statistically significant greater percentage of ubrogepant patients achieving absence of the most bothersome migraine-associated symptom at 2 hours after the initial dose as compared to placebo patients (50 mg vs placebo, p=0.0129). The 25 mg dose demonstrated improvement in the percentage of ubrogepant patients achieving absence of the most bothersome migraine-associated symptom at 2 hours after the initial dose as compared to placebo patients, however failed to demonstrate statistical significance (25 mg vs placebo, p=0.0711). The 50 mg dose of ubrogepant also showed a statistically significant greater percentage of patients achieving pain relief at 2 hours, sustained pain relief from 2-24 hours, and sustained pain freedom from 2-24 hours after the initial dose as compared to placebo (50 mg vs placebo, p=0.0129 for each of these endpoints). In addition, ubrogepant 50 mg also showed a statistically significant greater percentage of patients achieving absence of photophobia (p= 0.0167) and phonophobia (p= 0.0440) at 2 hours after the initial dose as compared to placebo. Ubrogepant 25 mg compared to placebo failed to demonstrate statistical significance in these endpoints. In ACHIEVE II, ubrogepant was well tolerated and demonstrated a safety profile similar to placebo.