The millions of Americans who suffer from migraine may have a new source of hope -- the first drug aimed at preventing the headaches gained U.S. Food and Drug Administration approval on Thursday.
Researchers have found that the injected drug, called Aimovig, or erenumab, can prevent migraines if other treatments have failed to do so.
"Aimovig provides patients with a novel option for reducing the number of days with migraine," Dr. Eric Bastings, deputy director of the division of neurology products in the FDA's Center for Drug Evaluation and Research, said in an agency news release.
"We need new treatments for this painful and often debilitating condition," he said.
Millions of people suffer from the throbbing pain, light and sound sensitivity, and nausea that can come with migraines.
Aimovig works by blocking a key brain "neurotransmitter" chemical that sends out pain signals, explained a team of researchers who presented their study findings last month at the annual meeting of the American Academy of Neurology (AAN) in Los Angeles.
Working with a group of people with tough-to-treat migraine, the "study found that [Aimovig] reduced the average number of monthly migraine headaches by more than 50 percent for nearly a third of study participants," lead researcher Dr. Uwe Reuter, of The Charite University Medicine Berlin in Germany, said in an AAN news release.
The FDA's approval on Thursday was spurred by the results of studies just like that one.
One study involved 955 people with episodic migraine who were given either Aimovig or a placebo for six months. In that trial, use of the drug was tied to one to two fewer migraine days per month.
In the second study, 577 patients with episodic migraine were given Aimovig or a placebo for three months. Again, those on the drug had at least one less day of headache in a month. Similar results were found in a third, three-month study involving 667 patients -- this time, Aimovig users had 2.5 fewer migraine days per month, the FDA said.
The most common side effects were some injection-site reactions and constipation.
The estimated cost of the drug is $7,000 annually and may be covered by insurance, according to published reports.