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Neurocrine Biosciences Announces FDA Acceptance of New Drug Application for Opicapone as an Adjunctive Treatment for Patients with Parkinson's Disease
SAN DIEGO, July 10, 2019 /PRNewswire/ -- Neurocrine Biosciences, Inc. (NASDAQ: NBIX) today announced that the U.S. Food and Drug Administration (FDA) has
About this update from Neurocrine Biosciences, Inc.
[{"type":"text","content":"SAN DIEGO, July 10, 2019 /PRNewswire/ -- Neurocrine Biosciences, Inc. (NASDAQ: NBIX) today announced that the U.S. Food and Drug Administration (FDA) has accepted its New Drug Application (NDA) for opicapone, a novel, once-daily, oral, selective catechol-O-methyltransferase (COMT) inhibitor as an adjunctive treatment to levodopa/carbidopa in patients with Parkinson's disease experiencing OFF episodes. Parkinson's disease is a chronic, progressive and debilitating neurodegenerative disorder that affects approximately one million people in the U.S. The FDA has set a standard 12-month review process with a Prescription Drug User Fee Act (PDUFA) target action date of April 26, 2020. \n\n \n\"People living with Parkinson's disease often struggle to control their motor fluctuations due to the progressive neurodegenerative effects of the disorder. With opicapone, we aim to prolong the benefits of levodopa by providing a new treatment option to patients with Parkinson's disease in the U.S.,\" said Eiry W. Roberts, M.D., Chief Medical Officer, Neurocrine Biosciences. \"It is our goal to help patients maintain good ON time – the period when their motor symptoms are better controlled – and reduce OFF time – the period when the effects of levodopa have worn off. We look forward to working with the FDA to bring this new treatment option to patients coping with this debilitating disorder.\"\nThe NDA for opicapone is supported by data from 38 clinical studies, including two Phase III studies (BIPARK-1 and BIPARK-2), with more than 1,000 Parkinson's disease patients treated with opicapone. BIPARK-1 was a Phase III, randomized, double-blind placebo- and active-controlled study of opicapone as an adjunct to levodopa therapy in which approximately 600 patients with Parkinson's disease and motor fluctuations received once-daily opicapone (5 mg, 25 mg, or 50 mg), placebo, or 200 mg doses of the COMT inhibitor entacapone for 14 to 15 weeks. BIPARK-2 was a Phase III, randomized, double-blind placebo-controlled study of opicapone as an adjunct to levodopa therapy in which approximately 400 patients with Parkinson's disease and motor fluctuations received once-daily opicapone (25 mg or 50 mg) or placebo for 14 to 15 weeks. The primary endpoint in both studies was the change from baseline in absolute time in the OFF state, as assessed by patient diaries....