SAN DIEGO, Oct. 25, 2017 /PRNewswire/ -- Neurocrine
Biosciences, Inc. (NASDAQ: NBIX) announced today that it has
initiated a Phase IIb clinical trial, T-Force GOLD, for
INGREZZA® (valbenazine), a novel selective vesicular
monoamine transporter 2 (VMAT2) inhibitor, in children and
adolescents with Tourette syndrome. Tourette syndrome is a
neurological disorder that becomes evident in early childhood or
adolescence and is characterized by motor and vocal tics.
"We are committed to continuing studies of INGREZZA in patients
with neurological disorders including pediatric patients with
Tourette syndrome," said Christopher F.
O'Brien, Chief Medical Officer of Neurocrine Biosciences.
"We have gained valuable insights from our previous studies of
INGREZZA in patients with Tourette syndrome and look forward to
continuing to advance this program to further assess INGREZZA as a
potential treatment option for pediatric Tourette patients."
INGREZZA capsules are marketed in the United States for the treatment of adults
with tardive dyskinesia, a condition associated with
uncontrollable, abnormal and repetitive movements of the trunk,
extremities and/or face.
T-Force GOLD Study Design
The T-Force GOLD study is a
multicenter, randomized, double-blind, placebo-controlled, parallel
group, Phase IIb study to evaluate the safety, tolerability,
efficacy and optimal dose of once-daily INGREZZA in up to 120
pediatric patients with moderate to severe Tourette syndrome.
Patients will receive either once-daily dosing of INGREZZA or
placebo using a 1:1 randomization over 12 weeks of dosing followed
by two weeks off-drug. The primary endpoint of this study is the
change from baseline of the Yale Global Tic Severity Scale between
placebo and active treatment groups at the end of week 12. Tourette
symptoms will also be evaluated via the Premonitory Urge for Tics
Scale as well as Clinical Global Impression Scales. Top-line data
from this study is expected in late 2018.
About Tourette Syndrome
Tourette syndrome is a
neurological disorder that consists of rapid, non-rhythmic
stereotyped motor and vocal tics. Motor tics are typically
characterized by facial grimacing, head jerks, extremity movements
and other stereotyped movements. Vocal tics typically include
grunting, throat clearing, and repeating words and phrases. The
average age of onset for Tourette syndrome is six years, with
symptoms reaching their peak severity at approximately age ten.
Tourette syndrome is more commonly diagnosed in males than females
and may be associated with attention deficit hyperactivity disorder
and obsessive-compulsive disorder.
About INGREZZA® (valbenazine)
capsules
INGREZZA, a selective 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
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; the value INGREZZA brings
to patients and caregivers; and whether results from INGREZZA's
clinical trials can be replicated or 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 development and 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 completed on a timely basis or at all;
risks that INGREZZA clinical trial results may not replicate
previous clinical trial results or 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 June 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.