WASHINGTON, Dec. 23 (Xinhua) -- The U.S. Food and Drug Administration (FDA) greenlighted a new drug on Monday for the immediate treatment of migraine, a kind of intense and persistent headache, in adults.
Ubrelvy tablets are the first drug in the class of oral calcitonin gene-related peptide receptor antagonists. The peptide is a molecule that is involved in migraine attacks.
Unlike Aimovig, a drug approved by the FDA in May 2018, Ubrelvy is not indicated for the preventive treatment of migraine.
"Migraine is an often disabling condition that affects an estimated 37 million people in the U.S.," said Billy Dunn, acting director of the office of neuroscience in the FDA's center for drug evaluation and research, in a statement.
Migraine is three times more common in women than in men, and it affects more than 10 percent of people worldwide, according to the FDA.
Ubrelvy's effectiveness is based on two randomized, double-blind, placebo-controlled trials. A total of 1,439 adult patients with a history of migraine received the approved doses of Ubrelvy to treat an ongoing migraine.
In both studies, the percentages of patients achieving pain freedom, and patients whose migraine symptoms including nausea, light sensitivity and sound sensitivity stopped two hours after the treatment, were significantly greater among those receiving Ubrelvy at all doses compared to those receiving placebo.
"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," Dunn said.