Publication date: Jul 11, 2019
SAN DIEGO, July 10, 2019 /PRNewswire/ –^A 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.
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.
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.
In June 2016, BIAL cE2€“ Portela CA, S. A. (BIAL) received approval from the European Commission for ONGENTYS^A(R) (opicapone) as an adjunct therapy to preparations of levodopa/DOPA decarboxylase inhibitors (DDCIs) in adult patients with Parkinson’s disease and end-of-dose motor fluctuations who cannot be stabilized on those combinations.
In June 2016, the European Commission approved ONGENTYS^A(R) (opicapone) as an adjunct therapy to preparations of levodopa/DOPA decarboxylase inhibitors (DDCIs) in adult patients with Parkinson’s disease and end-of-dose motor fluctuations who cannot be stabilized on those combinations.
Among the factors that could cause actual results to differ materially from those indicated in the forward-looking statements are: the risks and uncertainties the Company faces include risks that the opicapone NDA may not obtain regulatory approval from the FDA or such approval may be delayed or conditioned; risks that additional regulatory submissions may not occur or be submitted in a timely manner; risks or uncertainties related to the development of opicapone; risks and uncertainties relating to competitive products and technological changes that may limit demand for opicapone; risks associated with the Company’s dependence on BIAL for development and manufacturing activities related to opicapone, and the ability of the Company to manage BIAL; risks that the FDA or other regulatory authorities may make adverse decisions regarding opicapone; risks that clinical development activities may not be completed on time or at all; risks that clinical development activities may be delayed for regulatory, manufacturing, or other reasons, may not be successful or replicate previous clinical trial results, may fail to demonstrate that our product candidates are safe and effective, or may not be predictive of real-world results or of results in subsequent clinical trials; risks that the benefits of the agreement with BIAL may never be realized; risks that our product candidates may be precluded from commercialization by the proprietary or regulatory rights of third parties, or have unintended side effects, adverse reactions or incidents of misuse; and other risks described in the Company’s periodic reports filed with the Securities and Exchange Commission, including without limitation the Company’s quarterly report on Form 10-Q for the quarter ended March 31, 2019.
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