SAN DIEGO, Dec. 5, 2016 /PRNewswire/ -- Neurocrine
Biosciences, Inc. (NASDAQ: NBIX), a biotechnology company focused
on neurological and endocrine related disorders, announced today
that two abstracts representing additional data from several
clinical trials of the investigational drug
INGREZZATM (valbenazine) are being presented at the
Annual Meeting of the American College of Neuropsychopharmacology
in Hollywood, Florida. The posters
include an evaluation of the safety and effectiveness of long-term
dosing of INGREZZA in the treatment of tardive dyskinesia.
The two posters that will be presented at 5:30pm ET on Monday
December 5, 2016 are:
- Efficacy of Valbenazine (NBI-98854) in Subjects with Tardive
Dyskinesia: Results of a Long-Term Extension Study (KINECT 3
Extension)
- Safety and Tolerability of Valbenazine (NBI-98854) in Subjects
with Tardive Dyskinesia: Results of Long-Term Exposure Data from
Three Studies
"We are pleased to share the positive and compelling long-term
treatment data of INGREZZA in tardive dyskinesia patients with the
broader scientific community," said Chris
O'Brien, M.D. Chief Medical Officer of Neurocrine
Biosciences. "The results presented today are encouraging for both
patients and prescribers and demonstrate that INGREZZA has the
potential to bring long-term relief to patients suffering from
tardive dyskinesia."
The abstracts show that throughout the one year of treatment
with INGREZZA, during the blinded, extension phase of the study,
subjects continued to demonstrate sustained improvement in the
reduction of their tardive dyskinesia symptoms after the six-week
placebo-controlled portion of the study was completed.
Additionally, the Clinical Global Impression of Tardive Dyskinesia
Symptoms showed a clinically meaningful improvement in symptoms at
the end of treatment. The one-year safety data indicates that
INGREZZA was generally well tolerated, with no notable change in
adverse event frequency over the year of dosing. Importantly, the
evaluations utilizing various psychiatric scales over the period of
treatment showed no worsening of underlying psychiatric health
status (schizophrenia or mood disorders).
About Tardive Dyskinesia
Tardive dyskinesia is characterized by involuntary, repetitive
movements of the face, trunk, or extremities, including lip
smacking, grimacing, tongue protrusion, facial movements or
blinking, puckering and pursing of the lips. These symptoms are
rarely reversible and there are currently no FDA approved
treatments.
About INGREZZA
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. INGREZZA (valbenazine or 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. INGREZZA 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, may provide symptomatic
benefits for patients with these diseases.
Neurocrine received Breakthrough Therapy Designation from
the U.S. Food and Drug Administration (FDA) in 2014 for
INGREZZA in the treatment of tardive dyskinesia. The New Drug
Application (NDA) for INGREZZA for the treatment of tardive
dyskinesia is currently under Priority Review with the FDA.
The proprietary name INGREZZA has been conditionally accepted by
the FDA.
The Company is also investigating the safety and efficacy of
INGREZZA in the treatment of Tourette syndrome. The Company has two
ongoing placebo-controlled Phase II Tourette syndrome studies
evaluating INGREZZA in adults and pediatrics, the T-Forward study
and T-Force GREEN study, respectively. Additionally, the Company
has recently launched an open-label, fixed-dose rollover study of
INGREZZA 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 INGREZZA, a vesicular monoamine
transporter 2 inhibitor for the treatment of movement
disorders. Neurocrine plans to commercialize INGREZZA in
the United States upon approval of
the NDA by the FDA.
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 INGREZZA (valbenazine)
development and commercialization. Specifically, the risks and
uncertainties the Company faces include risks that INGREZZA
development activities may not be completed on time or at all;
risks that INGREZZA development activities may be delayed for
regulatory or other reasons, may fail to demonstrate that INGREZZA
is safe and effective, or may not be predictive of real-world
results or of results in subsequent clinical trials; risks that
INGREZZA regulatory submissions may not occur or be submitted in a
timely manner; risks that INGREZZA 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 INGREZZA; risks that INGREZZA 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
INGREZZA; risks that the Company will be unable to raise additional
funding, if required, to complete development of, or commercialize,
INGREZZA; risks and uncertainties relating to competitive products
or technological changes that may limit demand for INGREZZA; and
other risks described in the Company's quarterly report
on Form 10-Q for the quarter ended September 30, 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.