The study, dubbed Achieve II, looks at the efficacy, safety, and tolerability of 25 mg and 50 mg doses of ubrogepant versus placebo for the treatment of a single migraine attack.
The main outcomes being measured in the study are freedom from pain two hours after the initial dose, and the absence of the most bothersome symptom two hours after the initial dose. Those symptoms include extreme sensitivity to light (photophobia), fear of loud sounds (phonophobia) and nausea.
Allergan, an Action Alerts PLUS holding, said both doses demonstrated a statistically significant greater percentage of patients achieving freedom from pain two hours after the initial dose versus placebo patients. The 50 mg dose also showed a statistically significant greater percentage of ubrogepant patients that no longer experience the most bothersome symptom two hours after the initial dose versus placebo patients.
As for the 25 mg dose, Allergan said it showed improvement in the percentage of ubrogepant patients achieving absence of the most bothersome symptom at two hours after the initial dose versus placebo patients, but did not show statistical significance.
The Dublin drugmaker said it anticipates filing a new drug application to the U.S. Food and Drug Administration next year.
"The consistency in response between both Achieve I and Achieve II provides further evidence that ubrogepant...offers a promising opportunity for the acute treatment of migraine," said Allergan chief research and development officer David Nicholson in a statement.
Shares of Allergan closed at $160.53 on Thursday, up 2.2%. The stock was up 0.2% to $160.78 on Friday morning. The company reports its March quarter earnings on Monday before the market opens.