Positive results have been announced from ACHIEVE I (UBR-MD-01), the first of two pivotal phase 3 clinical trials evaluating the efficacy, safety, and tolerability of Allergan’s orally administered ubrogepant 50 mg and ubrogepant 100 mg compared with placebo in a single migraine attack in adults.
The ACHIEVE I study included 1,327 U.S. adults randomized (1:1:1) to placebo, ubrogepant 50 mg, and 100 mg, 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 two hours after the initial dose compared with placebo patients (50 mg versus placebo, P = 0.0023; 100 mg versus placebo, P = 0.0003). In addition, a statistically significant greater percentage of ubrogepant patients achieved absence of the most bothersome migraine-associated symptom at two hours after the initial dose of either ubrogepant strength compared with placebo patients (50 mg versus placebo, P = 0.0023; 100 mg versus placebo, P = 0.0023).
Ubrogepant was well tolerated, with an adverse event profile similar to placebo. The most common adverse events were nausea, somnolence, and dry mouth, none of which were reported with a frequency of 5%. In terms of hepatic safety, across all treatment arms including placebo, there were six cases with aminotransferase elevations greater than three times the upper limit of normal; there were alternative explanations in all cases (concomitant illness or medication), and none were noted by the liver safety adjudication board to have a probable relationship to ubrogepant. There were no cases of Hy's law.
Additional results from this study are anticipated to be released at upcoming scientific meetings throughout 2018. Results of the second phase 3 trial, ACHIEVE II (UBR-MD-02), are expected in the first half of 2018. Allergan anticipates filing a new drug application to the FDA in 2019.
Ubrogepant is a novel, highly potent, orally administered CGRP receptor antagonist in development for the acute treatment of migraine. CGRP and its receptors are expressed in regions of the nervous system associated with migraine pathophysiology. CGRP receptor antagonism is a novel mechanism of action for the acute treatment of migraine that differs from the mechanisms of currently available triptans (serotonin 1B/1D agonists) and opioids.
Source: Allergan; February 6, 2018.