FDA approves new treatment for migraines in adults

U.S. Food and Drug Administration recently approved Ubrivevy tablets for acute (immediate) treatment of migraines in adults, with or without precursors (sensory phenomena or visual impairments), and Ubrelvy was not used to prevent migraines. The first drug in oral calcitonin gene-related peptide antagonists has been approved for acute treatment of migraines.
"Migraines are a frequently disabling disease that affects about 37 million people in the United States," said Dr. Billy Dunn, acting director of the Office of Neuroscience at the FDA's Center for Drug Evaluation and Research. Acute treatment for migraines in adults because it is the first drug of its kind to be approved for the condition. The FDA is pleased to approve a novel treatment for migraine patients and will continue to work with stakeholders to promote the development of new safe and effective migraine treatments.
migraines are often described as severe throbbing or throbbing pain in one part of the head, and other symptoms include nausea and/or vomiting, as well as sensitivity to light and sound. About one-third of migraine sufferers also had pre-eclamsia not so long ago. Migraines: Precursor can appear as flickering lights, jagged lines, or temporary vision loss. Migraines can often be triggered by a variety of factors, including stress, hormonal changes, bright or flashing lights, malnutrition, insomnia, and inadequate diet. The incidence rate among women is three times that of men, affecting more than 10 per cent of the world's population.
Ubrelvy's effectiveness in acute treatment of migraines was demonstrated in two randomized, double-blind, placebo-controlled trials. In these studies, 1,439 adult patients with a history of migraine disease, with or without precursores, received an approved dose of Ubrelvy to treat persistent migraines. In both studies, the percentage of patients who achieved painlessness two hours after treatment (defined as reducing ubrelvy treatment at all doses) had significantly higher headache symptoms (moderate or severe pain to no pain) and the most annoying migraine symptoms (nausea, light sensitivity, or sound sensitivity) after 2 hours of treatment. Regular acute migraine treatment is allowed at least two hours after receiving Ubrelvy. Twenty-three percent of patients are taking migraine prevention drugs.
The most common side effects reported by patients in clinical trials were nausea, tiredness, and dry mouth. Ubrelvy is associated with powerful CYP3A4 inhibitors. （cyy123.com）