Migraine sufferers now have a new tool in their arsenal to fight the debilitating headaches with federal approval of Allergan's first oral medication proven to ease migraine symptoms within two hours — even after they've started.
The Food and Drug Administration approved Ubrelvy, the company's ubrogepant treatment, on Monday. The oral medication is aimed at treating migraines in patients who are unresponsive to common migraine treatments, such as triptans, or are at risk of cardiovascular disorders. Allergan, which anticipated a December approval by the FDA, said Ubrelvy will be available for sale in the U.S. in the first quarter.
"Migraine is an often disabling condition that affects an estimated 37 million people in the U.S.," Dr. Billy Dunn, acting director of the Office of Neuroscience in the FDA's Center for Drug Evaluation and Research, said in a statement. "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. 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."
Earlier this month, Allergan announced top-line results from its phase 3 clinical trial, which measured ubrogepant doses of 50 milligrams and 100 mg compared with a placebo in a single migraine attack of moderate-to-severe headache intensity. The drugmaker reported that the two doses demonstrated "clinically significant pain relief" within two hours and provided relief for up to 24 hours.
"As we continue to drive innovation in migraine treatment, we are very proud to offer patients another option, and we are confident that it will make a difference for those in need," David Nicholson, Allergan's chief research and development officer, said in a statement.
The most common adverse effect reported was nausea, which occurred in less than 5% of users, the company said.
Ubrogepant is the latest drug to be approved in a wave of new treatments for migraines, which affect more than 10% of adults in the U.S.
The drug stands out from other migraine treatments that were recently approved, such as Eli Lilly's Emgality, Amgen's Aimovig and Teva Pharmaceutical's Ajovy. It's meant to treat migraines at the onset, rather than be used as a prevention, and is a pill, rather than an injection.
Though Allergan's approval comes just two months after the FDA approved Eli Lilly's Reyvow, a tablet that's also proven to resolve migraine pain and symptoms within two hours.
Additionally, Biohaven Pharmaceutical's rimegepant, also an oral migraine treatment, is expected to gain regulator approval in early 2020 to treat acute migraines.