FDA Approves New Migraine Treatment

This week, the U.S. Food and Drug Administration (FDA) approved Ubrelvry (ubrogepant) tablets for the immediate treatment of migraine with or without aura in adults. According to the FDA, this marks the first drug in the class of oral calcitonin gene-related peptide receptor antagonists approved for the acute treatment of migraine.

Ubrelvy’s efficacy was assessed in two randomized, double-blind, placebo-controlled trials comprised of 1,439 adult patients with a history of migraine, with and without aura (a sensory phenomenon or visual disturbance). In these studies, where 23% of patients were taking a preventive medication for migraine, participants were permitted to take their habitual acute migraine treatment at least two hours after taking Ubrelvy.

According to the results of both studies, the percentages of patients who achieved pain freedom following two hours of treatment (defined as a reduction in headache severity from moderate or severe pain to no pain) and whose most bothersome migraine symptom (either nausea, light sensitivity or sound sensitivity) stopped two hours subsequent to treatment were notably higher among those who received Ubrelvy at all doses juxtaposed to the placebo control group. The most common side effects reported by patients taking Ubrelvry in these trials were nausea, fatigue, and dry mouth. The FDA noted that Ubrelvy is contraindicated for co-administration with strong CYP3A4 inhibitors.

“Migraine is an often disabling condition that affects an estimated 37 million people in the U.S.,” said Billy Dunn, M.D., acting director of the Office of Neuroscience in the FDA’s Center for Drug Evaluation and Research in a press release. “Ubrelvy 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. 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.”