FDA Approves Ubrogepant for Acute Treatment of Migraine

The Food and Drug Administration (FDA) has approved ubrogepant (Ubrelvy; Allergan, Cambridge, MA) for the acute (immediate) treatment of migraine with or without aura in adults. This is the first small molecule orally available calcitonin gene-related peptide (CGRP) antagonist to be approved for any indication. Ubrogepant is approved for acute treatment of migraine once an attack begins, not for prevention of migraine.

In the ACHIEVE I study (NCT02828020) 21.2% of patients treated with 100 mg ubrogepant and 19.2% of those treated with 50 mg ubrogepant had pain relief after 2 hours vs 11.8% of patients treated with placebo (P=.0023, P=.0003). Relief from most bothersome symptoms that included sensitivity to light or sound and nausea, was 38.6% and 37.7% for those who took 100 mg or 50 mg ubrogepant vs 27.8% for placebo (P=.023 for both doses). Across all clinical trials, over 1,439 adults with a history of migraine were treated with ubrogepant or placebo. In all trials, treatment with ubrogepant provided freedom from pain and relief from most bothersome symptom for a higher proportion of people treated with ubrogepant vs placebo. Participants were allowed to take their usual acute treatment of migraine at least two hours after taking ubrogepant, and 23% of participants were taking a preventive medication for migraine.

As quoted previously in Practical Neurology, Dr. Jessica Ailani, a neurologist and Director of the Medstar Georgetown Headache Center has said, "Despite its prevalence and burden, migraine remains an undertreated disease, with many patients continuing to seek additional treatment options from their physicians. . . ubrogepant, the first innovation in the acute treatment of migraine in over 25 years, will be used across the entire spectrum of the disease (from episodic to chronic), helping patients achieve relief in the moments when they most demand it."

The most common side effects participants in clinical trials reported were nausea, tiredness, and dry mouth. Ubrogepant is contraindicated for coadministration with strong CYP3A4 inhibitors. In a safety study, approximately 500 healthy adults received 2 days of consecutive treatment with 100 mg ubrogepant, alternating with 2 days of placebo, mimicking how episodic migraine is often treated. No treatment-related adverse events were higher with ubrogepant vs placebo, and no hepatic safety issue were seen.

“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.”