Successful ACHIEVE I (UBR-MD-01) Phase III study of ubrogepant to treat migraine attacks.- Allergan.

Allergan plc , announced positive results from ACHIEVE I (UBR-MD-01), the first of two pivotal phase III clinical trials 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 ACHIEVE I study included 1327 U.S. adult patients (modified ITT population) 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. 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 (50 mg vs placebo, p=0.0023, 100 mg vs placebo, p=0.0003) and 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=0.0023, 100 mg vs placebo, p=0.0023). Ubrogepant was well tolerated with an adverse event profile similar to placebo.

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

Comment: The four leaders in the anti-CGRP field � Amgen Inc. with Novartis AG, Alder BioPharmaceuticals Inc., Eli Lilly & Co. and Teva Pharmaceutical Industries Ltd. are developing monoclonal antibodies. If Allergan�s two drugs (MK-1602 and MK-8031) can meet the injectable medicines, or come close to their efficacy, the oral alternatives are likely to win a sizeable portion of CGRP inhibitor sales and significantly increase the company�s presence in the migraine market beyond Botox .