FDA OKs Ubrogepant (Ubrelvy) for Acute Migraine Treatment

Megan Brooks

December 23, 2019

The US Food and Drug Administration (FDA) has approved ubrogepant (Ubrelvy, Allergan) for the acute treatment of migraine with or without aura in adults.

Ubrogepant is the first drug in the class of oral calcitonin gene-related peptide receptor antagonists approved for the acute treatment of migraine. It is approved in two dose strengths (50 mg and 100 mg).

The drug is not indicated, however, for the preventive treatment of migraine.

"Migraine is an often disabling condition that affects an estimated 37 million people in the US," Billy Dunn, MD, acting director of the office of neuroscience in the FDA's Center for Drug Evaluation and Research, said in an FDA news release.

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. 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," added Dunn.

The safety and efficacy of ubrogepant for the acute treatment of migraine was demonstrated in two randomized, double-blind, placebo-controlled trials (ACHIEVE I and ACHIEVE II). In total, 1439 adults with a history of migraine, with and without aura, received ubrogepant to treat an ongoing migraine.

"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," Allergan said in a news release announcing approval.  

The most common side effects reported by patients in the clinical trials were nausea, tiredness, and dry mouth. Ubrogepant is contraindicated for coadministration with strong CYP3A4 inhibitors.

The company expects to have ubrogepant available in the first quarter of 2020.

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