Allergan Announces Second Positive Phase 3 Trial For Ubrogepant

(RTTNews) - Allergan plc (AGN) announced positive results from ACHIEVE II (UBR-MD-02), the second of two pivotal Phase 3 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.

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.