SAN DIEGO, May 6, 2016 /PRNewswire/ -- Neurocrine Biosciences, Inc. (NASDAQ: NBIX) announced today that four abstracts representing additional data from both the Kinect 3 and Kinect 2 tardive dyskinesia clinical trials of valbenazine will be presented at the American Psychiatric Association Annual Meeting in May. The four posters will include an evaluation of the impact of valbenazine on the psychiatric stability of subjects with underlying schizophrenia, schizoaffective disorder or mood disorder (including bipolar disorder or major depressive disorder), data assessing the effect of valbenazine stratified by baseline tardive dyskinesia severity, and an evaluation of valbenazine with concomitant antipsychotic use. The APA Annual Meeting is the largest international conference of psychiatrists and behavioral health specialists, bringing together an estimated 13,000 clinicians and scientists to address current topics in psychiatry.
Valbenazine data will be presented at the APA Annual Meeting poster sessions at the following dates and times:
Monday May 16th 2pm-4pm
- Tardive Dyskinesia and Valbenazine (NBI-98854) Response as a Function of Concomitant Antipsychotic Use
Tuesday May 17th 2pm-4pm
- Valbenazine (NBI-98854) is Effective for Treating Tardive Dyskinesia in Individuals with Schizophrenia or Mood Disorder
- KINECT 3: A Randomized, Double-Blind, Placebo-Controlled Phase 3 Trial of Valbenazine (NBI-98854) for Tardive Dyskinesia
- Psychiatric Stability Maintained in Tardive Dyskinesia Subjects Treated with Valbenazine (NBI-98854)
"We are very pleased to have four abstracts accepted for presentation at the American Psychiatric Association Annual Meeting in Atlanta in May. This meeting, coupled with our American Academy of Neurology presentations in April, demonstrates to health care providers the breadth and depth of our tardive dyskinesia clinical data across multiple treatment paradigms," said Chris O'Brien, M.D., Chief Medical Officer at Neurocrine. "We have submitted seven abstracts between the American Academy of Neurology and the American Psychiatric Association Annual Meetings and all seven have been accepted; evidence of the consistency, quality and strength of the data emerging from our clinical program."
VMAT2 is a protein concentrated in the human brain that is primarily responsible for re-packaging and transporting monoamines (dopamine, norepinephrine, serotonin, and histamine) in pre-synaptic neurons. Valbenazine (NBI-98854), developed in the Neurocrine laboratories, is a novel, highly-selective VMAT2 inhibitor that modulates dopamine release during nerve communication, while at the same time having minimal impact on the other monoamines, thereby reducing the likelihood of "off-target" side effects. Valbenazine is designed to provide low, sustained, plasma and brain concentrations of active drug to minimize side effects associated with excessive monoamine depletion.
Modulation of neuronal dopamine levels in diseases such as tardive dyskinesia, Tourette syndrome, Huntington's chorea, schizophrenia, and tardive dystonia, which are characterized, in part, by a hyperdopaminergic state, may provide symptomatic benefits for patients with these diseases.
Neurocrine has received Breakthrough Therapy Designation from the FDA for valbenazine in the treatment of tardive dyskinesia and expects to file a New Drug Application for tardive dyskinesia in 2016. Valbenazine is also currently in Phase II development for Tourette syndrome.
About Neurocrine Biosciences
Neurocrine Biosciences, Inc. discovers and develops innovative and life-changing pharmaceuticals, in diseases with high unmet medical needs, through its novel R&D platform, focused on neurological and endocrine based diseases and disorders. The Company's two lead late-stage clinical programs are elagolix, a gonadotropin-releasing hormone antagonist for women's health that is partnered with AbbVie Inc., and valbenazine, a vesicular monoamine transporter 2 inhibitor for the treatment of movement disorders. Neurocrine intends to maintain certain commercial rights to its VMAT2 inhibitor for evolution into a fully-integrated pharmaceutical company.
Neurocrine Biosciences, Inc. news releases are available through the Company's website via the internet at http://www.neurocrine.com.
In addition to historical facts, this press release may contain 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 NBI-98854 (valbenazine) development. Specifically, the risks and uncertainties the Company faces include risks that valbenazine development activities may not be completed on time or at all; risks that valbenazine development activities may be delayed for regulatory or other reasons, may fail to demonstrate that valbenazine is safe and effective, or may not be predictive of real-world results or of results in subsequent clinical trials; risks that valbenazine regulatory submissions may not occur or be submitted in a timely manner; risks that valbenazine may not obtain regulatory approval or that the U.S. Food and Drug Administration or regulatory authorities outside the U.S. may make adverse decisions regarding valbenazine; risks that valbenazine may be precluded from commercialization by the proprietary rights of third parties, or have unintended side effects, adverse reactions or incidents of misuse; risks associated with the Company's dependence on third parties for development and manufacturing activities related to valbenazine; risks that the Company will be unable to raise additional funding, if required, to complete development of valbenazine; risks and uncertainties relating to competitive products and technological changes that may limit demand for valbenazine; and other risks described in the Company's quarterly report on Form 10-Q for the quarter ended March 31, 2016. Neurocrine disclaims any obligation to update the statements contained in this press release after the date hereof.
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SOURCE Neurocrine Biosciences, Inc.