SAN DIEGO, Nov. 29, 2017 /PRNewswire/ -- Neurocrine
Biosciences, Inc. (NASDAQ: NBIX) today announced that new long-term
data from the open-label KINECT 4 Phase III study of
INGREZZA® (valbenazine) capsules, the first FDA approved
treatment for adults with tardive dyskinesia (TD), will be
presented at the Hot Topics Session at the American College of
Neuropsychopharmacology (ACNP) Annual Meeting December 3-7 in Palm
Springs, California.
"Neurocrine is committed to helping patients who struggle with
both tardive dyskinesia and their psychiatric condition," said
Christopher O'Brien, M.D., Chief
Medical Officer of Neurocrine Biosciences. "These new data,
combined with additional sub-group analyses from the INGREZZA
clinical program, will help neurologists and psychiatrists further
understand the role of INGREZZA for the treatment of
uncontrollable, abnormal and repetitive movements of the trunk,
extremities and face."
The four Neurocrine-related abstracts, including the abstract
being presented at the Hot Topics Session, at the ACNP Annual
Meeting are:
- KINECT 4: A Phase 3, One-Year, Open-Label Trial of
Valbenazine in Participants with Tardive Dyskinesia (T159)
Hot Topics Session: Sunday, Dec. 3,
2:30-2:45 p.m.
Poster Session: Tuesday, Dec. 5,
5:30-7:30 p.m.
- Effects of Valbenazine on Prolactin in Adults with Tardive
Dyskinesia: Pooled Results from 3 Randomized, Double-Blind,
Placebo-Controlled Trials (M149)
Poster Session I: Monday, Dec. 4,
5:30-7:30 p.m.
- Can Presynaptic and Postsynaptic Monoaminergic Mechanisms
Work Synergistically? Current Findings and Future Directions
(T224)
Poster Session II: Tuesday, Dec. 5,
5:30-7:30 p.m.
- Valbenazine in Tardive Dyskinesia of Older and Younger
Adults: Pooled Results from 3 Randomized, Double-Blind,
Placebo-Controlled Trials (W152)
Poster Session III: Wednesday, Dec.
6, 5:30-7:30 p.m.
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 that INGREZZA clinical trials results may not be predictive
of real-world results or of results in subsequent clinical trials;
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 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.