Allergan’s migraine drug ubrogepant has succeeded in a phase 3 trial by meeting its co-primary endpoints for a 50mg dose.
The CGRP receptor antagonist, which was orally administered, was assessed in both 25mg and 50mg doses in comparison to placebo for the acute treatment of migraine in 1,686 adult patients with moderate-to-severe headache intensity.
For both the doses, a statistically significant greater percentage of patients in the ubrogepant arm was recorded with the patients experiencing freedom from pain at two hours after the initial dose, in comparison to patients treated with placebo. This was one of the co-primary efficacy parameters of the Achieve II trial.
Further, the 50mg dose of ubrogepant showed a statistically significant greater percentage of patients in the ubrogepant arm who were relieved from most bothersome migraine-associated symptom at two hours after the initial dose, in comparison to placebo patients. This was the second primary efficacy of the trial.
Although the 25mg dose of ubrogepant did register absence of the most bothersome migraine-related symptom at two hours after the initial dose, compared to the placebo arm, it could not show statistical significance, said Allergan.
Achieve II is the second of two pivotal phase 3 clinical studies assessing ubrogepant’s efficacy, safety and tolerability in addition to Achieve I. In February, Allergan said that Achieve I met its co-primary endpoints.
Allergan chief research and development officer David Nicholson said: “The consistency in response between both Achieve I and Achieve II provides further evidence that ubrogepant, an oral calcitonin gene-related peptide (CGRP) receptor antagonist, offers a promising opportunity for the acute treatment of migraine.
"Allergan is committed to addressing unmet patient needs through product innovation and has identified a clear need in the migraine marketplace."
Allergan said that it expects to submit a new drug application (NDA) for ubrogepant to the US Food and Drug Administration in 2019.
Ubrogepant has been designed to block the CGRP receptor which is expressed in regions of the nervous system and is associated with migraine pathophysiology.
Image: Allergan site in Westport, Ireland. Photo: courtesy of ALLERGAN.