FDA approves Ubrelvy for acute treatment of migraine

The FDA has approved Ubrelvy, the first oral calcitonin gene-related peptide receptor antagonist intended for acute treatment of migraine in adults, according to an agency press release.

“Ubrelvy represents an important new option for the acute treatment of migraine in adults,” Billy Dunn, MD, acting director of the Office of Neuroscience in the FDA’s Center for Drug Evaluation and Research, said in a press release. “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.”

According to the FDA, the effectiveness of Ubrelvy (ubrogepant, Allergan) was demonstrated in two randomized, double-blind, placebo-controlled trials consisting of 1,439 patients. The agency stated that in both studies, the percentages of patients experiencing freedom from pain 2 hours after treatment and whose most bothersome migraine symptom ceased 2 hours after treatment were significantly greater among ubrogepant recipients than placebo recipients.

The FDA stated that the most common adverse events that patients reported were dry mouth, nausea and tiredness and dry mouth. The agency also stated that ubrogepant is contraindicated for co-administration with strong CYP3A4 inhibitors.

Disclosures: Dunn is employed by the FDA.