SAN DIEGO, Aug. 29, 2016 /PRNewswire/ -- Neurocrine
Biosciences, Inc. (NASDAQ: NBIX) today announced that it has
submitted a New Drug Application (NDA) to the U.S. Food and Drug
Administration (FDA) for once-daily dosing of valbenazine in
treating tardive dyskinesia.
"This is an important milestone in the development of
valbenazine for the treatment of tardive dyskinesia, a serious
disease for which there is no FDA approved pharmaceutical
treatment," said Kevin C. Gorman,
President and Chief Executive Officer of Neurocrine Biosciences.
"We look forward to working with the FDA in their review of the
valbenazine NDA submission to potentially bring this important
treatment option to patients and physicians."
The NDA for valbenazine includes the results from the Kinect 2
and Kinect 3 clinical trials which evaluated over 330 tardive
dyskinesia patients. Data from these studies along with the results
from another 18 clinical trials, extensive preclinical testing and
drug manufacturing data were included in the NDA submission. The
Company expects to receive notification of the acceptance of the
NDA, as well as the timeframe for NDA review from the FDA in
October 2016.
About Tardive Dyskinesia
Tardive dyskinesia is characterized by involuntary, repetitive
movements of the face: lip smacking, grimacing, tongue protrusion,
facial movements or blinking, puckering and pursing of the lips, or
the extremities. These symptoms are rarely reversible and there are
currently no FDA approved treatments.
About Valbenazine
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, showing little or no affinity for VMAT1, other
receptors, transporters and ion channels. Valbenazine is designed
to provide low, sustained, plasma and brain concentrations of
active drug to allow for once daily dosing.
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, should 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.
The Company is also investigating the safety and efficacy of
valbenazine in the treatment of Tourette syndrome. The Company has
two ongoing placebo-controlled Phase II Tourette syndrome studies
evaluating valbenazine in adults and pediatrics, the T-Forward
study and T-Force GREEN study, respectively. Each of these studies
is expected to enroll up to 90 subjects with Tourette syndrome.
Additionally, the Company has recently launched an open-label,
fixed-dose rollover study of valbenazine in up to 180 subjects with
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 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 valbenazine development.
Specifically, the risks and uncertainties the Company faces include
risks that the valbenazine NDA may not be accepted for filing by
the FDA or may not obtain regulatory approval for tardive
dyskinesia or such approval may be delayed; risks that additional
regulatory submissions may not occur or be submitted in a timely
manner; risks that that the U.S. Food and Drug Administration
or regulatory authorities outside the U.S. may make adverse
decisions regarding valbenazine; risks that valbenazine development
activities for Tourette syndrome may not be completed on time or at
all; risks that ongoing valbenazine development activities may be
delayed for regulatory or other reasons, may not be successful or
replicate previous clinical trial results, may fail to demonstrate
that valbenazine is safe, tolerable or effective, or may not be
predictive of real-world results or of results in subsequent
clinical trials; 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 or
commercialize 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 June 30, 2016. Neurocrine disclaims any
obligation to update the statements contained in this press release
after the date hereof.
To view the original version on PR Newswire,
visit:http://www.prnewswire.com/news-releases/neurocrine-submits-new-drug-application-for-valbenazine-for-treatment-of-tardive-dyskinesia-300319485.html
SOURCE Neurocrine Biosciences, Inc.