SAN DIEGO, Nov. 14, 2017 /PRNewswire/ -- Neurocrine
Biosciences, Inc. (NASDAQ: NBIX) announced today that the full
manuscript of the long-term safety and efficacy data from the
blinded KINECT 3 Phase III extension study evaluating
INGREZZA® (valbenazine) capsules for the treatment of
adults with tardive dyskinesia (TD) were published in
the Journal of Clinical Psychiatry1. The
once-daily 80 mg and 40 mg doses of INGREZZA continued to maintain
symptom improvement and were generally well-tolerated over
long-term dosing in patients with TD, a condition characterized by
uncontrollable, abnormal and repetitive movements of the trunk,
extremities and/or face.
"We are pleased with the long-term data, which demonstrate the
ability of INGREZZA to effectively improve the symptoms of tardive
dyskinesia with durable response," said Christopher O'Brien, M.D., Chief Medical Officer
of Neurocrine Biosciences. "The data also showed that INGREZZA was
generally well-tolerated and did not interfere with the effects of
concomitant antipsychotic and antidepressant medications."
Data from the KINECT 3 Phase III extension study included
results from 198 patients receiving INGREZZA for long-term
treatment of TD. Patients who continued after the initial six-week
controlled study period maintained TD improvement as measured by
the Abnormal Involuntary Movement Scale (AIMS) and Clinical Global
Impression of Change-TD (CGI-TD) through the 42-week INGREZZA
double-blind extension period, with scores returning towards
baseline after a 4-week INGREZZA washout period. Patients taking
INGREZZA showed no apparent risk for suicidal ideation or behavior,
nor did INGREZZA appear to induce or worsen akathisia or
parkinsonism. Generally, the psychiatric status of patients in the
study remained stable during the study.
About the KINECT 3 Phase III Extension
Study
Participants who completed the 6-week, double-blind,
placebo controlled period of the KINECT 3 Phase III extension study
were eligible to enter the 42-week INGREZZA extension period and
subsequent 4-week washout period. Participants who received placebo
and entered the extension period were re-randomized 1:1 to INGREZZA
40 mg or 80 mg while others continued their KINECT 3 dose in a
blinded manner. Safety assessments included treatment-emergent
adverse events (TEAEs), scales for suicidal ideation/behavior,
treatment-emergent akathisia or parkinsonism, and psychiatric
symptoms. Efficacy assessments included the AIMS and CGI-TD
scales.
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.
References
1.
|
Factor S et al.The Effects of Valbenazine in
Participants with Tardive Dyskinesia: Results of the 1-Year KINECT
3 Extension Study J Clin Psychiatry;
https://doi.org/10.4088/JCP.17m11777
|
View original
content:http://www.prnewswire.com/news-releases/neurocrine-announces-long-term-results-evaluating-ingrezza-for-the-treatment-of-adults-with-tardive-dyskinesia-published-in-the-journal-of-clinical-psychiatry-300555802.html
SOURCE Neurocrine Biosciences, Inc.