ST. GEORGE — The U.S. Food and Drug Administration approved a new drug treatment Monday for the immediate treatment of migraines in adults – with or without aura, a sensory phenomenon or visual disturbance.
According to a press release from the FDA, Ubrelvy (ubrogepant) is the first drug in the class of oral calcitonin gene-related peptide receptor antagonists approved for the acute treatment of migraine headaches. The tablets are not indicated for the preventive treatment of migraines.
“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 the press release. “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.”
Migraine headache pain is often described as an intense throbbing or pulsating pain in one area of the head. Additional symptoms include nausea and/or vomiting and sensitivity to light and sound. Approximately one third of individuals who suffer from migraine also experience aura shortly before the migraine. An aura can appear as flashing lights, zig-zag lines, or a temporary loss of vision.
Migraines can often be triggered by various factors, including stress, hormone changes, bright or flashing lights, lack of food or sleep and diet. Migraines are three times more common in women than in men and affect more than 10% of people worldwide.
According to the press release, the effectiveness of Ubrelvy for the acute treatment of migraine was demonstrated in two randomized, double-blind, placebo-controlled trials. In these studies, 1,439 adult patients with a history of migraines – with and without aura – received the approved doses of Ubrelvy to treat an ongoing migraine.
In both studies, the percentages of patients achieving pain freedom – defined as a reduction in headache severity from “moderate” or “severe” pain to “no pain” – and the cessation of their bothersome individual migraine symptoms two hours after treatment were significantly greater among patients receiving Ubrelvy at all doses compared to those receiving placebo.
Patients were allowed to take their usual acute treatment of migraine at least two hours after taking Ubrelvy. Of the patients in the studies, 23% were taking a preventive medication for migraine.
The most common side effects that patients in the clinical trials reported were nausea, tiredness and dry mouth. Ubrelvy is contraindicated for co-administration with strong CYP3A4 inhibitors.
The FDA granted the approval of Ubrelvy to Allergan USA, Inc.
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