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Xadago (Safinamide) additional treatment for Parkinson’s disease approved by the FDA

Mar 23, 2017

Xadago (Safinamide) additional treatment for Parkinson’s disease approved by the FDA

The United States Food and Drug Administration (FDA) has sanctioned and approved Xadago® (safinamide) drug tablets as an additional supplement treatment for patients suffering from Parkinson’s disease and are presently having carbidopa/levodopa and going through ‘off’ episodes, i.e., causing increased Parkinson’s symptoms like trouble in walking and tremor in spite of taking the medciations. The drug has been formulated by Newron Pharmaceuticals S.p.A, a biopharmaceutical company that aims on solely developing new therapies for patients who have diseases of the central nervous system (CNS) and the pain associated with it, along with partners US WorldMeds, LLC, and ZambonS.p.A.It has been estimated that Parkinson’s disease nearly affects 7 to 10 million people across the world, of which almost a million are in the U.S. It is the second most progressive chronic neurodegenerative disorder in the geriatric population after Alzheimer’s disease. Parkinson’s disease is a degenerative disorder of the central nervous system which is characterized by impaired muscular coordination and tremors.The diagnosis is primarily dependent on observational criteria of resting tremor, muscular rigidity, or postural instability compounding with bradykinesia.The symptoms become more severe when the disease progresses. About the drug: Safinamide (brand name – Xadago) is a drug meant for treating Parkinson’s disease with monoamine oxidase B inhibition (MAO-B-inhibitor). In February 2105, it was approved in Europe, and in the United States on March 212017.Safinamide is a once-daily dosage and has no specific restrictions in the diet owing to its elevated MAO-B against MAO-A selectively.The efficiency of Xadago while treating the patients was revealed in a clinical trial of 645 participants who were also consuming levodopa and were going through ‘off’ time. Patients who received Xadago felt benefits of ‘on’ time, wherein the symptoms are lessened, with no tremor and involuntary movement, i.e., dyskinesia, as compared to those patients receiving an inert medication. The rise in ‘on’ time was supplemented by decrease in ‘off’ time and improved scores on a measure of motor function evaluated at the time of ‘on’ time than prior to treatment. Also, the most common adversarial reactions witnessed in patients consuming safinamide were nausea, insomnia, falls, and an uncontrolled involuntary movement.

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