FDA Approves New Drug That Immediately Treats Migraines

Migraines, a particularly severe type of headache that can cause pain and visual disturbances, often last for hours or days, disrupting one's life. Pain killers and other acute treatments often fail to provide relief from these migraines; instead, most treatments are for preventing chronic migraines. That has changed with the FDA's approval of a new drug that offers immediate, rather than preventative, relief.

Migraines are often difficult to treat. Though some people will only experience migraines rarely, others suffer from chronic migraines, which means they happen regularly. Migraines can be triggered by a variety of factors, including everything from excessively bright light exposure to allowing one's blood sugar to drop too low before eating a carb-rich meal.

In an announcement on Monday, the FDA revealed that it has approved ubrogepant (brand Ubrelvy) tablets for the treatment of migraines, but only in adults. The drug can be used to treat migraines that occur with or without auras, meaning things like rainbow shimmers in one's vision. The agency says Ubrelvy is the first oral calcitonin gene-related peptide receptor antagonist to get its approval for immediate migraine treatment.

In a statement, FDA Office of Neuroscience acting director Billy Dunn, MD, said:

Migraine is an often disabling condition that affects an estimated 37 million people in the US. 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.

A pair of double-blind, randomized, and placebo-controlled trials were used to test Ubrelvy's effectiveness. More than 1,400 adults participated in the studies, all of them with a history of migraines. Compared to the placebo group, the FDA says many sufferers who took this drug during a migraine experienced a reduction in symptoms or, in some cases, complete relief within two hours.