Allergan unveils second bout of Phase 3 success in migraine
pharmafile | April 30, 2018 | News story | Research and Development, Sales and Marketing | Allergan, migraine, pharma, ubrogepant
Allergan has revealed new data from the second of two Phase 3 studies into the efficacy of its calcitonin gene-related peptide (CGRP) receptor antagonist ubrogepant, showing that the drug met its primary endpoint in the treatment of single migraine attack of moderate-to-severe intensity in adult patients.
The firm tested the product in both 25mg and 50mg oral forms against placebo in 1,686 US patients. In a modified intention-to-treat (mITT) population of these participants, totalling 1,355, it was found that a “statistically significant greater percentage of ubrogepant patients” achieved the trial’s primary endpoint of pain freedom two hours after the initial dose compared to placebo. In the two dose groups, 20.7% and 21.8% of patients achieved pain freedom within two hours, compared to just 14.3% for placebo.
In the 50mg group, 38.9% of patients achieved the trial’s other primary endpoint of absence of the most bothersome migraine-related symptom after two hours, coming in “significantly greater” than the placebo group with 27.4%. The same goal was reached by 34.1% of the lower-dose group, a score which Allergan noted did not reach statistical significance.
The results reinforce the findings of a previous study in February, where 50mg and 100mg doses of ubrogepant demonstrated “significant improvements” over placebo in the treatment of single migraine attack.
“We are pleased to share these positive results from ACHIEVE II, our second Phase 3 study supporting the efficacy, safety, and tolerability of 50 mg ubrogepant. 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 David Nicholson, Chief Research and Development Officer at Allergan. “Allergan is committed to addressing unmet patient needs through product innovation and has identified a clear need in the migraine marketplace.”
“Given the prevalence of migraine and significant disability that many patients face, ubrogepant may provide a new option for those having tolerability issues with current migraine-specific treatments.” added Dr Stephen Silberstein, Director, Headache Center, Thomas Jefferson University. “In addition, a need exists for treatments when there is a contraindication to migraine-specific medications. Results from ACHIEVE II will lead to a new treatment that will improve the lives of patients.”
Allergan plans to file a New Drug Application for the product in 2019.
Matt Fellows
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