Neurocrine Biosciences Announces FDA Acceptance of New Drug Application for Opicapone as an Adjunctive Treatment for Patients with Parkinson’s Disease

Neurocrine Biosciences Announces FDA Acceptance of New Drug Application for Opicapone as an Adjunctive Treatment for Patients with Parkinson’s Disease

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.

Concepts Keywords
Adjunct Therapy Carbidopa
Biopharmaceutical Neuroscience
Bradykinesia Catechol-O-methyltransferase inhibitor
Brain Opicapone
Canada Bial
Carbidopa Neurocrine Biosciences
Catechol Nitrophenols
Clinical Trial Catecholamines
Clinical Trials Catechols
Congenital Adrenal Hyperplasia Organic compounds
Coping Aromatic compounds
DOPA Decarboxylase Phenols
Dopamine Investigational treatment
Dopaminergic Movement bradykinesia tremor
Double Blind Parkinson s disease
Endocrine Nervous endocrine systems
Endocrine Systems Biopharmaceutical company years
Endometriosis Chemical
Entacapone Regulatory manufacturing reasons
European Commission Manufacturing activities
FDA
Germany
Investigational Drug
Italy
Levodopa
Methyldopa
Methyltransferase
NASDAQ
Nasdaq
NDA
Neurodegenerative Disorder
Neurological
Neuroscience
Parkinson
Placebo
Portugal
Primary Endpoint
Progressive
Psychiatric Disorders
SAN DIEGO
San Diego
Securities Exchange Commission
Spain
Tardive Dyskinesia
Tremor
United Kingdom
Uterine Fibroids

Semantics

Type Source Name
drug DRUGBANK Opicapone
gene UNIPROT NAA50
drug DRUGBANK Nonoxynol-9
gene UNIPROT COMT
drug DRUGBANK Levodopa
drug DRUGBANK Carbidopa
disease MESH neurodegenerative disorder
gene UNIPROT SET
disease MESH Drug User
gene UNIPROT ACOT7
gene UNIPROT ACTG2
gene UNIPROT ACTBL2
gene UNIPROT SERPINA3
gene UNIPROT ACTG1
gene UNIPROT POTEM
gene UNIPROT FHL5
gene UNIPROT ANP32B
gene UNIPROT TNFSF13
gene UNIPROT CD5L
gene UNIPROT CD69
gene UNIPROT DNMT1
drug DRUGBANK Tropicamide
drug DRUGBANK Entacapone
disease MESH development
drug DRUGBANK Dopamine
disease MESH bradykinesia
disease MESH tremor
disease MESH posture
drug DRUGBANK Isoxaflutole
disease MESH tardive dyskinesia
disease MESH multiple
disease MESH congenital adrenal hyperplasia
disease DOID congenital adrenal hyperplasia
disease MESH uterine
drug DRUGBANK Methylergometrine
drug DRUGBANK Coenzyme M
pathway BSID Release
gene UNIPROT CEP55

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