FDA approves ubrogepant for acute migraine in adults

The US Food and Drug Administration (FDA) has approved ubrogepant (Ubrelvy) for the acute treatment of migraine with or without aura in adults in adults. Ubrelvy is not indicated for the preventive treatment of migraine. It is the first drug in the class of oral calcitonin gene-related peptide receptor antagonists approved for the acute treatment of migraine.

The FDA granted the approval of Ubrelvy to Allergan USA, Inc.

Migraine is often described as an intense throbbing or pulsating pain in one area of the head. Other accompaying symptoms include nausea and/or vomiting and sensitivity to light and sound. Approximately one-third of individuals who suffer from migraine also experience aura shortly before the migraine.Migraine is three times more common in women than in men and affects more than 10% of people worldwide.

“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. “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.”

The effectiveness of Ubrelvy for the acute treatment of migraine was demonstrated in two randomized, double-blind, placebo-controlled trials. In these studies, 1,439 adult patients with a history of migraine, with and without aura, received the approved doses of Ubrelvy to treat an ongoing migraine. In both studies, the percentages of patients achieving pain freedom two hours after treatment (defined as a reduction in headache severity from moderate or severe pain to no pain) and whose most bothersome migraine symptom (nausea, light sensitivity or sound sensitivity) stopped two hours after treatment were significantly greater among patients receiving Ubrelvy at all doses compared to those receiving placebo. Patients were allowed to take their usual acute treatment of migraine at least two hours after taking Ubrelvy. 23% of patients were taking preventive medication for migraine.

The most common side effects that patients in the clinical trials reported were nausea, tiredness, and dry mouth. Ubrelvy is contraindicated for co-administration with strong CYP3A4 inhibitors.