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Neurocrine Biosciences Announces FDA Approval of Once-Daily ONGENTYS® (opicapone) as an Add-On Treatment for Patients with Parkinson's Disease Experiencing "Off" Episodes
- ONGENTYS, the First and Only Approved Once-Daily COMT Inhibitor, Decreases "Off" Time and Increases "On" Time Without Troublesome Dyskinesia When Added to
About this update from Neurocrine Biosciences, Inc.
[{"type":"text","content":"- ONGENTYS, the First and Only Approved Once-Daily COMT Inhibitor, Decreases \"Off\" Time and Increases \"On\" Time Without Troublesome Dyskinesia When Added to Levodopa/Carbidopa in Patients with Parkinson's Disease\n - Neurocrine Biosciences Plans to Make ONGENTYS Available to Patients Later This Year\n\n\nSAN DIEGO, April 27, 2020 /PRNewswire/ -- Neurocrine Biosciences, Inc. (Nasdaq: NBIX) today announced that the U.S. Food and Drug Administration (FDA) has approved once-daily oral ONGENTYS® (opicapone) 25 mg and 50 mg capsules as an add-on treatment to levodopa/carbidopa in patients with Parkinson's disease experiencing \"off\" episodes. As the disease progresses, patients taking levodopa/carbidopa may begin to experience \"off\" time between treatment doses, during which an increase in Parkinson's disease motor symptoms such as tremor, slowed movement and difficulty walking occur. ONGENTYS also increases \"on\" time without troublesome dyskinesia, the time when the motor symptoms of a patient with Parkinson's disease are better controlled. The company plans to launch ONGENTYS later this year. \nExperience the interactive Multichannel News Release here: https://www.multivu.com/players/English/8719751-neurocrine-biosciences-ongentys/ \n\"The FDA approval of ONGENTYS represents an important new treatment option for people with Parkinson's disease,\" said Robert A. Hauser, M.D., Professor of Neurology and Director, University of South Florida Parkinson's Disease and Movement Disorders Center. \"As Parkinson's disease progresses, first-line treatments such as levodopa begin to lose effectiveness and the beneficial effects of levodopa begin to wear off more quickly, causing more frequent and often debilitating motor fluctuations in patients. Clinical studies have shown that adding once-daily ONGENTYS to levodopa therapy significantly reduced \"off\" time, leading to better and more consistent motor symptom control.\"\nParkinson's disease is the second most common neurodegenerative disorder in the United States after Alzheimer's disease.1 About one million Americans have Parkinson's disease and each year, an estimated 50,000 people in the United States are newly diagnosed with this chronic, progressive and debilitating neurodegenerative disorder. \n\"The FDA approval of ONGENTYS provides patients living with Parkinson's disease wi...