Officials with the FDA today approved Allergan’s ubrogepant (Ubrelvy) tablets 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 by the agency for the acute treatment of migraine.

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

“Migraine is an often disabling condition that affects an estimated 37 million people in the US,” said Billy Dunn, MD, acting director of the Office of Neuroscience in the FDA’s Center for Drug Evaluation and Research, in a prepared statement.

Migraine headache pain is often described as an intense throbbing or pulsating pain in one area of the head. Additional symptoms include nausea and/or vomiting and sensitivity to light and sound.

Approximately 1/3 of individuals who suffer from migraine also experience aura shortly before the migraine, according to the FDA. An aura can appear as flashing lights, zig-zag lines, or a temporary loss of vision.

Migraines can often be triggered by various factors including stress, hormone changes, bright or flashing lights, lack of food or sleep, and diet. Migraine is 3 times more common in women than in men, and affects more than 10% of people worldwide.

The effectiveness of ubrogepant for the acute treatment of migraine was demonstrated in 2 randomized, double-blind, placebo-controlled trials. In these studies, 1439 adult patients with a history of migraine, with and without aura, received the approved doses of ubrogepant to treat an ongoing migraine.

In both studies, the percentages of patients achieving pain freedom 2 hours after treatment—defined as a reduction in headache severity from moderate or severe pain to no pain—and whose most bothersome migraine symptom stopped 2 hours after treatment were significantly greater among patients receiving ubrogepant at all doses ,compared to those receiving placebo. Patients were allowed to take their usual acute treatment of migraine at least 2 hours after taking ubrogepant, and 23% of patients were taking a preventive medication for migraine.

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


FDA approves new treatment for adults with migraine [news release]. Silver Spring, MD; December 23, 2019: FDA website. Accessed December 23, 2019.