SAN DIEGO, Nov. 7, 2017 /PRNewswire/ -- Neurocrine
Biosciences, Inc. (NASDAQ: NBIX) today announced that data for
INGREZZA® (valbenazine) capsules, the first FDA approved
treatment for adults with tardive dyskinesia (TD), will be
presented at the 2017 Neuroscience Education Institute Congress to
be held November 8-12 in Colorado Springs, Colorado. Data being
presented include analyses from the RE-KINECT study, a real-world
screening study and registry that describes the presence and impact
of involuntary movements in patients taking antipsychotics, as well
as pooled data analyses from INGREZZA clinical studies across
patient sub-groups.
"We are pleased to share findings on the impact of tardive
dyskinesia, which is characterized by uncontrollable, abnormal and
repetitive movements, on real-world patients," said Chris O'Brien, M.D., Chief Medical Officer of
Neurocrine. "With the data from the real-world patient study and
further analyses from INGREZZA clinical studies, we have gained
valuable insight into the complexities and needs of patients and
the effects of INGREZZA on addressing the symptoms of tardive
dyskinesia."
Neurocrine's five posters will be presented during the poster
sessions on Friday, November 10, 2017
from 5:45 p.m. – 8:00 p.m. MT:
- 117: RE-KINECT: Real-World Dyskinesia Screening Study and
Registry in Patients Taking Antipsychotic Agents: Interim Baseline
Burden of Illness Results
- 118: Demographics and Real-World Healthcare Utilization for
Patients with Probable Tardive Dyskinesia
- 132: Effects of Valbenazine on Depression and Suicidality in
Adults with Tardive Dyskinesia: Pooled Results of 3 Double-Blind,
Placebo-Controlled Trials
- 141: The Effects of Valbenazine on Tardive Dyskinesia: Subgroup
Analyses of 3 Randomized, Double-Blind, Placebo-Controlled
Trials
- 150: Estimation of an MCID for AIMS Total Score Change in
Tardive Dyskinesia
About Tardive Dyskinesia (TD)
Tardive dyskinesia
(TD) is characterized by uncontrollable, abnormal and
repetitive movements of the trunk, extremities and/or face. The
condition is associated with treatments that block dopamine
receptors in the brain, such as antipsychotics commonly prescribed
to treat mental illnesses such as schizophrenia, bipolar disorder
and depression and certain anti-nausea medications. In patients
with TD, these treatments are thought to result in irregular
dopamine signaling in a region of the brain that controls movement.
The symptoms of TD may be severe and are often persistent and
irreversible. TD is estimated to affect at least 500,000 people in
the U.S.
About INGREZZA® (valbenazine) Capsules
INGREZZA, a selective vesicular monoamine transporter 2 (VMAT2)
inhibitor, is the first FDA approved product indicated for the
treatment of adults with tardive dyskinesia, a condition associated
with uncontrollable, abnormal and repetitive movements of the
trunk, extremities and/or face.
INGREZZA is thought to work by reducing the amount of dopamine
released in a region of the brain that controls movement and motor
function, helping to regulate nerve signaling in adults with
tardive dyskinesia. VMAT2 is a protein in the brain that packages
neurotransmitters, such as dopamine, for transport and release in
presynaptic neurons. INGREZZA, developed in Neurocrine's
laboratories, is novel in that it selectively inhibits VMAT2 with
no appreciable binding affinity for VMAT1, dopaminergic (including
D2), serotonergic, adrenergic, histaminergic, or muscarinic
receptors. Additionally, INGREZZA can be taken for the treatment of
tardive dyskinesia as one capsule, once-daily, together with
psychiatric medications such as antipsychotics or antidepressants.
INGREZZA is currently in clinical development for the treatment of
Tourette syndrome.
Important Safety Information
Warnings &
Precautions
Somnolence
INGREZZA can cause
somnolence. Patients should not perform activities requiring mental
alertness such as operating a motor vehicle or operating hazardous
machinery until they know how they will be affected by
INGREZZA.
QT Prolongation
INGREZZA may prolong the QT interval,
although the degree of QT prolongation is not clinically
significant at concentrations expected with recommended dosing.
INGREZZA should be avoided in patients with congenital long QT
syndrome or with arrhythmias associated with a prolonged QT
interval. For patients at increased risk of a prolonged QT
interval, assess the QT interval before increasing the dosage.
Adverse Reactions
The most common adverse reaction
(≥5% and twice the rate of placebo) is somnolence. Other
adverse reactions (≥2% and >placebo) include: anticholinergic
effects, balance disorders/falls, headache, akathisia, vomiting,
nausea, and arthralgia.
You are encouraged to report negative side effects of
prescription drugs to the FDA. Visit MedWatch at
www.fda.gov/medwatch or call 1-800-FDA-1088.
Please see INGREZZA full Prescribing Information at
www.INGREZZA.com/HCP
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 via the internet 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. These statements include, but are not limited to,
statements related to the benefits to be derived from INGREZZA and
whether results from INGREZZA's clinical trials are indicative of
real-world results. 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 the commercialization of
INGREZZA; risks and uncertainties relating to competitive products
and technological changes that may limit demand for INGREZZA; risks
associated with the Company's dependence on third parties for
development and manufacturing activities related to INGREZZA and
the ability of the Company to manage these third parties; risks
that the FDA or other regulatory authorities may make adverse
decisions regarding INGREZZA; risks that INGREZZA clinical trials
may not be predictive of real-world results or of results in
subsequent clinical trials; risks that INGREZZA may be alleged to
infringe upon the proprietary rights of third parties, or have
unintended side effects, adverse reactions or incidents of misuse;
and other risks described in the Company's periodic reports filed
with the Securities and Exchange Commission, including without
limitation the Company's Quarterly Report on Form 10-Q for the
quarter ended September 30, 2017. The
Company disclaims any obligation to update the statements contained
in this press release after the date hereof.
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SOURCE Neurocrine Biosciences, Inc.