SAN DIEGO, April 18, 2018 /PRNewswire/ -- Neurocrine
Biosciences, Inc. (NASDAQ: NBIX) today announced that new data for
once-daily INGREZZA® (valbenazine) capsules, the first
U.S. Food and Drug Administration (FDA) approved treatment for
adults with tardive dyskinesia (TD), will be presented at the
American Academy of Neurology (AAN) Annual Meeting in Los Angeles, Calif., April 21-27, 2018. Highlighted presentations
include analysis of the short- and long-term effects of INGREZZA on
TD symptoms by body region, long-term INGREZZA safety and efficacy
data from the KINECT 4 Phase III open-label study and data from
RE-KINECT, a real-world screening study of patients with possible
TD.
"The symptoms of tardive dyskinesia are heterogeneous, with each
patient experiencing tardive dyskinesia somewhat differently.
Patients can experience uncontrollable, abnormal and repetitive
movements in different regions of the body, including the trunk,
extremities and face. Symptoms can also change over time," said
Eiry W. Roberts, M.D., Chief Medical Officer at Neurocrine. "For
these reasons it is important for us to assess the effects of
INGREZZA by body region and to understand the long-term efficacy
and tolerability of INGREZZA. We look forward to presenting these
additional data to help neurologists further understand the
potential of INGREZZA as a treatment for tardive dyskinesia."
Four Neurocrine posters will be presented during the "Movement
Disorders: Tardive Dyskinesia" poster session on Wednesday, April 25, 2018 from 5:30 - 7:00 p.m. PT:
- Short- and Long-term Effects of Once-Daily Valbenazine on
Tardive Dyskinesia by Body Region (P4-079)
- Effects of Long-term Valbenazine on Tardive Dyskinesia and
Patient-Reported Outcomes: Results from the KINECT 4 Study
(P4-078)
- RE-KINECT: A Prospective Real-world Dyskinesia Screening
Study and Registry in Patients Taking Antipsychotic Agents: Patient
Demographics (P4-083)
- Estimation of an MCID for AIMS Total Score Change in Tardive
Dyskinesia (P4-074)
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.
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
annual report on Form 10-K for the year ended December 31, 2017. 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.