The U.S. Food and Drug Administration approved a new drug to treat migraines that's proven to resolve their pain and other symptoms within two hours, the agency said Friday.
The drug, Reyvow, was developed by Eli Lilly and Co. and was proven to be "significantly" more effective than a placebo in halting the pain and "most bothersome" migraine symptoms, including nausea and light sensitivity.
Migraines, an intense headache accompanied by a throbbing or pulsing pain, affect one in seven Americans. Those suffering from migraines can also experience nausea, vomiting, and sensitivity to light and sound.
"Reyvow is a new option for the acute treatment of migraine, a painful condition that affects one in seven Americans," said Nick Kozauer, M.D., acting deputy director of Neurology Products for the FDA.
Migraines are three times more common in women than in men and affect more than 10% of people worldwide.
Reyvow was approved after two randomized, double-blind, placebo-controlled trials with 3,177 adult patients with histories of migraines. After both trials the percentages of patients whose pain or symptoms dissipated were significantly greater than those receiving a placebo.
The most common side effects patients reported from Reyvow were dizziness, fatigue, a burning or prickling sensation in the skin called paresthesia, and sedation.
Migraines can be triggered by various factors including stress, hormonal changes, bright or flashing lights, lack of food or sleep, and poor diet.