Both of the BIPARK Phase III trials included a one-year open-label extension where opicapone sustained the decrease in off-time and increase in on-time periods that was demonstrated during the double-blind placebo-controlled portion of the studies.About Neurocrine Biosciences, Inc.Neurocrine Biosciences is a San Diego based biotechnology company focused on neurologic, psychiatric and endocrine related disorders. The Company markets INGREZZA ® (valbenazine) capsules in the United States for the treatment of adults with tardive dyskinesia. INGREZZA is a novel, selective vesicular monoamine transporter 2 (VMAT2) inhibitor, and is the first FDA approved product indicated for the treatment of adults with tardive dyskinesia. The Company's three late-stage clinical programs are: elagolix, a gonadotropin-releasing hormone antagonist for women's health that is partnered with AbbVie Inc.; opicapone, a novel, once-daily, peripherally-acting, highly-selective catechol-o-methyltransferase inhibitor under investigation as adjunct therapy to levodopa in Parkinson's patients; and INGREZZA, a novel, once-daily, selective VMAT2 inhibitor under investigation for the treatment of Tourette syndrome. Neurocrine Biosciences, Inc. news releases are available through the Company's website at http://www.neurocrine.com. Forward-Looking Statements In addition to historical facts, this press release contains forward-looking statements that involve a number of risks and uncertainties. Among the factors that could cause actual results to differ materially from those indicated in the forward-looking statements are risks and uncertainties associated with Neurocrine's business and finances in general, as well as risks and uncertainties associated with opicapone development and commercialization. Specifically, the risks and uncertainties the Company faces include risks that opicapone may not obtain regulatory approval from the FDA or such approval may be delayed or conditioned; risks that opicapone development activities may not be completed on time or at all; risks associated with the Company's dependence on BIAL for development and manufacturing activities related to opicapone; risks that ongoing or future opicapone clinical trials may not be successful or replicate previous clinical trial results, or may not be predictive of real-world results or of results in subsequent clinical trials; risks that the FDA or regulatory authorities outside the U.S. may make adverse decisions regarding opicapone; risks that opicapone may be precluded from commercialization by the proprietary rights of third parties, or have unintended side effects, adverse reactions or incidents of misuse; risks and uncertainties relating to competitive products and technological changes that may limit demand for opicapone; and other risks described in the Company's periodic reports filed with the Securities and Exchange Commission, including without limitation the Company's annual report on Form 10-K for the year ended December 31, 2017. Neurocrine disclaims any obligation to update the statements contained in this press release after the date hereof.
View original content: http://www.prnewswire.com/news-releases/neurocrine-biosciences-will-file-new-drug-application-for-opicapone-for-parkinsons-disease-based-on-existing-pivotal-clinical-trial-data-300598899.htmlSOURCE Neurocrine Biosciences, Inc.