SAN DIEGO, Aug. 31, 2016 /PRNewswire/ -- Neurocrine
Biosciences, Inc. (NASDAQ: NBIX) today announced that the U.S. Food
and Drug Administration (FDA) has conditionally accepted the
proprietary name "INGREZZA™" for the Company's once-daily vesicular
monoamine transporter 2 (VMAT2) inhibitor valbenazine. The Company
has recently announced the submission of a New Drug Application
(NDA) with the FDA for valbenazine in tardive dyskinesia and is
also exploring its utility in Tourette syndrome.
The name INGREZZA (pronounced in-GREH-zah) was developed using
the FDA's Guidance for Industry, Contents of a Complete Submission
for the Evaluation of Proprietary Names consistent with the goal of
preventing medication errors. Additionally, the proprietary name
development program included prescribers, pharmacists and linguists
to create a unique, memorable name that helps to connote the
clinical value of INGREZZA.
The NDA for INGREZZA 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 filing. The
Company expects to receive notification of the acceptance of the
NDA filing, 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 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), 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, should provide symptomatic
benefits for patients with these diseases.
Neurocrine has received Breakthrough Therapy Designation from
the FDA for INGREZZA 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 INGREZZA (valbenazine or
NBI-98854), 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 INGREZZA development. Specifically,
the risks and uncertainties the Company faces include risks that
the INGREZZA 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 FDA or regulatory authorities outside the U.S.
may make adverse decisions regarding INGREZZA, including the risk
that the FDA may not approve INGREZZA as the proprietary name for
valbenazine; risks that INGREZZA development activities for
Tourette syndrome may not be completed on time or at all; risks
that ongoing INGREZZA 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
INGREZZA is safe, tolerable or effective, or may not be predictive
of real-world results or of results in subsequent clinical trials;
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 and 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 June 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.