The U.S. Food and Drug Administration has approved a new medicine Ubrelvy (ubrogepant) for migraines. It is particularly formulated for the treatment of acute migraine in the adult patients that may or may not suffer from aura (a sense related phenomenon or disturbance in the vision). Ubrelvy may prevent migraines in the early stages and does not help at chronic stages. It is the first drug approved drug in the class of oral calcitonin gene-related peptide receptor antagonist for acutely treating the migraine patients.
FDA is an agency that is working within the U.S Department of Health and Human Services. It aims is to protect public health by ensuring the effectiveness, safety, and security of human and veterinary vaccines, drugs and other biological products. The agency is also regulating the security and safety of the food, dietary supplements, cosmetics, products related to electronic radiations and tobacco products.
Migraine is an intense pulsating and throbbing pain usually in one area of the brain or head. It also followed by nausea, vomiting, and sensitivity to sound and light. One-third of patients usually suffer from the aura for a short time before going through the migraine condition.
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Aura is a condition appears as zig-zag lines, flashing lights or a temporary vision loss. Many other factors trigger the migraine including stress, bright or flashing lights, hormone changes, diet disturbance and lack of food or sleep. The rate of migraine is three times higher in women as compared to men. It affects more the 10 percent of the individuals across the world.
According to Billy Dunn who is the acting director of the office of Neurosciences in FDA’s Center for Drug Evaluation and Research that through an estimation migraine affects the 37 million people in the United States. People use only the pain relievers during the migraine condition as there was no specific treatment or medication available for migraines. Ubrelvy approval gives the patients a new option for acute treatment of migraine.
This drug is a novel treatment for the migraine patients approved by the FDA. The agency is still counting its work with the stakeholders for the development of more safe and effective therapies for the migraine.
Two randomized control trials were conducted for checking the effectiveness of the drug, Ubrelvy. The studies included double-blind and placebo-controlled trials for checking the acute treatment of migraines. In both the studies 1439 patients were enrolled with migraine history. The patients with or without aura were given approved doses of the drug to check the effectiveness of Ubrelvy. In both the studies the level of pain in the patients had been checked after two hours.
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The percentage of patients who told their freedom level from the pain was even greater. The pain reduces from the severe to low and from moderate to no pain. Some patients told that their pain stopped after two hours. These doses are compared with the placebo receiving patients for confirmation.
Patients were permitted to take their usual pain reliever after the two hours of receiving the Ubrelvy. 23 percent of patients were using the preventive drug for the acute treatment of migraine.
Nausea, dry mouth, and tiredness are the most common sides reported by the patients enrolled in the clinical trials. Ubrelvy is contraindicated with the strong inhibitors of CYP3A4 for co-administration.