The U.S. Food and Drug Administration (FDA) announced the approval of a new drug called ubrogepant (Ubrelvy) for the treatment of acute migraine, with or without aura, in adults.
However, the drug is not approved for the prevention of migraines.
Ubrogepant belongs to the class of drugs called calcitonin gene-related peptide receptor antagonists. It is the first FDA-approved drug for the treatment of acute migraine, which is approved in two doses – 50 mg and 100 mg.
Dr. Billy Dunn, acting director of the office of neuroscience in the FDA’s Center for Drug Evaluation and Research, said, “Migraine is an often disabling condition that affects an estimated 37 million people in the US.”
“Ubrogepant represents an important new option for the acute treatment of migraine in adults, as it is the first drug in its class approved for this indication,” added Dr. Dunn. “The FDA is pleased to approve a novel treatment for patients suffering from migraine and will continue to work with stakeholders to promote the development of new safe and effective migraine therapies.”
The approval was based on two clinical trials that demonstrated the safety and efficacy of ubrogepant in patients with acute migraine.
Allergan, the manufacturer of Ubrelvy, said, “Both 50 mg and 100 mg dose strengths demonstrated significantly greater rates of pain freedom and freedom from the most bothersome migraine-associated symptom at two hours, compared with placebo.”
Some of the common side effects of ubrogepant found in clinical trials were dry mouth, nausea, and fatigue. The drug is contraindicated in patients who are on strong CYP3A4 inhibitors. Allergan said the drug would be available in the first quarter of 2020.
