Allergan’s Ubrelvy (ubrogepant) has won clearance in the US for the treatment of acute treatment of migraine in adults, with or without aura.
The decision makes Ubrelvy the first oral CGRP receptor antagonist approved to treat acute migraines once they start, offering patients a new treatment option that works without constricting blood vessels, which some older treatments are known to do.
David Nicholson, EVP and chief R&D officer of the Dublin, Ireland-headquartered group, said the firm is confident that the drug will make a difference for those in need.
“As the first oral gepant, Ubrelvy offers a new and different type of acute treatment option for people living with the debilitating pain and other symptoms of migraine. Its oral administration with two dose strengths allows for treatment flexibility and relief when a migraine attack occurs.”
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).
Allergan said Ubrelvy will be available in the first quarter of 2020.