Allergan is gearing up to file its oral CGRP receptor ubrogepant in the US for the treatment of migraine, following the success and completion of two safety studies.
The Dublin, Ireland-headquartered group said it plans to submit a marketing application for the drug in the first quarter of next year, and a believes it will be the first oral CGRP receptor antagonist submitted in the US for the acute treatment of migraine with or without aura.
The announcement rides on the back of findings from a one-year study that Allergan noted “continue to support positive safety and tolerability profile for ubrogepant”, and also a two-month hepatic safety study in healthy volunteers which demonstrated no signal of drug-induced liver injury.
This follows positive efficacy data released at the beginning of this year.
In one study, both doses of the drug tested showed a statistically significant greater percentage of ubrogepant patients achieving pain freedom at two hours after initial dose versus placebo patients (50mg 19.2 percent; 100mg 21.2 percent; and placebo 11.8 percent).
Also, a statistically significant higher percentage of patients treated with ubrogepant achieved absence of the most bothersome migraine-associated symptom at two hours after the initial dose as compared to placebo patients (50mg 38.6 percent; 100mg 37.7 percent; and placebo 27.8 percent).
"We are pleased with the positive results from these two important studies supporting the safety and tolerability of ubrogepant and look forward to filing the NDA for this promising treatment option for adults living with migraine,” said David Nicholson, chief research and development officer, at Allergan.
“Despite the prevalence of migraine, there remains a need for additional therapeutic options for patients, some of whom are not candidates for currently available treatments," said Dr Richard Lipton, vice chair of Neurology, Professor of Epidemiology and Population Health and Director of the Montefiore Headache Center, all at the Albert Einstein College of Medicine. "Patients deserve new medications to help with their treatment needs and goals."