The first of two pivotal Phase III clinical trials evaluating Allergan’s experimental anti-CGRP migraine drug ubrogepant has met its key goal.
Both doses of the drug tested showed a statistically significant greater percentage of ubrogepant patients achieving pain freedom at two hours after initial dose versus placebo patients (50mg = 19.2 percent; 100mg = 21.2 percent’ and placebo = 11.8 percent).
Also, a statistically significant higher percentage of patients treated with ubrogepant achieved absence of the most bothersome migraine-associated symptom at two hours after the initial dose as compared to placebo patients (50mg = 38.6 percent; 100mg = 37.7 percent; and placebo = 27.8 percent).
Moreover, the drug was shown to be well-tolerated, with an adverse event profile similar to placebo. The most common side effects reported were nausea, somnolence, and dry mouth, none of which were reported with a frequency of more than 5 percent.
"We are pleased with the favorable results of our ACHIEVE I study, which support the efficacy, safety, and tolerability profile of ubrogepant,” said David Nicholson, the Dublin, Ireland-based firm’s chief R&D officer.
“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.”
Additional results from this study are to be showcased at upcoming scientific meetings throughout 2018, while findings from the second Phase III trial, ACHIEVE II, are anticipated in the 1st half of this year.
Allergan said it anticipates filing of a New Drug Application (NDA) to the FDA in 2019.