US regulators have accepted for review Allergan’s application to market ubrogepant for the acute treatment of migraine.
The Dublin, Ireland-headquartered group says it is hoping that the drug will become the first oral CGRP receptor antagonist approved to treat the condition.
The filing is based on data from four clinical trials, which show the efficacy, safety and tolerability of ubrogepant, as well as two additional safety studies.
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).
"Despite its prevalence and burden, migraine remains an undertreated disease, with many patients continuing to seek additional treatment options from their physicians," said Dr Jessica Ailani, a neurologist and Director of the Medstar Georgetown Headache Center.
"If approved, ubrogepant, the first innovation in the acute treatment of migraine in over 25 years, will be used across the entire spectrum of the disease (from episodic to chronic) helping patients achieve relief in the moments when they most demand it."
The company is expecting a decision from the US Food and Drug Administration during the fourth quarter of this year.