Allergan $AGN rolled out its second wave of positive Phase III data for its oral migraine drug ubrogepant, which nailed its endpoints in the higher dose but failed to elicit much effect in the lower amount.
The drug was tested in two doses: 25 mg and 50 mg alongside a placebo in 1,686 patients with single migraine attacks. The 50 mg dose of ubrogepant showed a statistically significant percentage of patients get pain relief at 2 hours, sustained pain relief from 2 to 24 hours, and sustained pain freedom from 2 to 24 hours after the initial dose as compared to placebo (p=0.0129 for each of these endpoints). More patients on the higher dose also showed an absence of photophobia (light sensitivity), and phonophobia (noise sensitivity).
However, the lower dose failed to show any statistical significance compared to placebo, researchers said.
Ubrogepant, which Allergan snatched from Merck a little more than two years ago, already showed positive Phase III results back in February for the Achieve I trial, which tested the drug in 50 mg and 100 mg doses.
We are pleased to share these positive results from Achieve II, our second Phase III study supporting the efficacy, safety, and tolerability of 50 mg ubrogepant,” said David Nicholson, chief research and development officer at Allergan. “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 anticipates filing of a new drug application to the FDA in 2019.
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