WASHINGTON -- Ubrogepant (Ubrelvy) became the first oral calcitonin gene-related peptide (CGRP) receptor antagonist (gepant) drug to win approval for migraine, the Monday.
The agency approved ubrogepant tablets for acute treatment of migraine with or without aura. The drug is not indicated for migraine prevention, the agency stated.
"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," said Billy Dunn, MD, acting director of the Office of Neuroscience in the FDA's Center for Drug Evaluation and Research, in a .
Ubrogepant's effectiveness was seen in two randomized, double-blind, placebo-controlled trials, and . In these studies, 1,439 adult patients with a history of migraine received 25 mg, 50 mg, or 100 mg of the drug to treat an ongoing migraine. In both studies, the percentage of patients achieving pain freedom 2 hours after treatment and whose most bothersome migraine symptom -- photophobia, phonophobia, or nausea -- stopped 2 hours after treatment were significantly greater with ubrogepant than with placebo.
Ubrogepant is a small-molecule gepant agent that blocks the CGRP receptor, inhibiting a pathway known to play a role in the pathophysiology of migraine.
"Ubrogepant will provide an acute treatment option for millions of people with migraine who do not respond to triptans or cannot take them," researcher Richard Lipton, MD, of the Montefiore Headache Center at the Albert Einstein College of Medicine in New York City, said when ACHIEVE II results were published.
While triptans have been widely prescribed for acute migraine treatment for many years, some patients cannot use them because of cardiovascular contraindications.
"We once believed that migraine-specific drugs had to constrict blood vessels to be effective, based on the vascular theory of migraine," Lipton told 鶹ý. "Ergots and triptans constrict blood vessels. Gepants do not constrict blood vessels. The effectiveness of gepants is another nail in the coffin of the vascular theory of migraine."
The most common side effects reported by patients in ubrogepant clinical trials were nausea, tiredness, and dry mouth. The drug is contraindicated for co-administration with strong CYP3A4 inhibitors, the FDA warned. More data can be found on the drug's sheet, drugmaker Allergan said.