SAN DIEGO, Dec. 4, 2017 /PRNewswire/ -- Neurocrine
Biosciences, Inc. (NASDAQ: NBIX) today announced that new long-term
data from the KINECT 4 Phase III open-label study demonstrate that
once-daily INGREZZA® (valbenazine) capsules, the first
FDA approved treatment for adults with tardive dyskinesia (TD),
improved TD symptoms through 48 weeks of open-label treatment and
was generally well tolerated. TD is characterized by
uncontrollable, abnormal and repetitive movements of the trunk,
extremities and/or face. These data were presented at the American
College of Neuropsychopharmacology (ACNP) Annual Meeting,
December 3-7 in Palm Springs, California.
"Neurocrine is committed to helping adult patients with tardive
dyskinesia, many of whom are in serious need of treatment to reduce
their uncontrollable movements that are often debilitating," said
Christopher O'Brien, M.D., Chief
Medical Officer of Neurocrine Biosciences. "Consistent with data
from previous Phase II/III clinical trials, these new long-term
Phase III open-label data will continue to help neurologists and
psychiatrists further understand the role of INGREZZA in helping
patients who are afflicted with tardive dyskinesia."
In addition to the KINECT 4 Phase III study results, Neurocrine
also presented pooled data analyses from three double-blind,
placebo-controlled INGREZZA studies (KINECT, KINECT 2 and KINECT 3)
across patient sub-groups (219 participants in the ≥55 years of age
subgroup and 154 participants in the <55 years of age subgroup).
Pooled data analyses showed that once-daily INGREZZA improved
tardive dyskinesia symptoms and was generally well tolerated in
both older and younger adults.
About the KINECT 4 Phase III Study
Data from the
KINECT 4 Phase III study included results from 163 adult patients
receiving INGREZZA for long-term treatment of TD which included a
48-week open-label treatment period and a 4-week washout/follow-up
period. Across all dose groups, 103 participants who completed the
48-week treatment period experienced clinically meaningful,
long-term TD improvement, based on Abnormal Involuntary Movement
Scale (AIMS) as assessed by site raters, Clinical Global Impression
of Change-TD (CGI-TD) and Patient Global Impression of Change
(PGIC) mean scores. Safety assessments included treatment-emergent
adverse events (TEAEs). All outcomes were analyzed using
descriptive statistics.
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 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.
View original
content:http://www.prnewswire.com/news-releases/neurocrine-biosciences-presents-long-term-data-analyses-from-open-label-kinect-4-phase-iii-study-demonstrating-ingrezza-improves-tardive-dyskinesia-symptoms-300566119.html
SOURCE Neurocrine Biosciences, Inc.