SAN DIEGO, Dec. 12, 2018 /PRNewswire/ -- Neurocrine
Biosciences, Inc. (NASDAQ: NBIX) today announced topline data from
the Phase IIb T-Force GOLD study demonstrating that valbenazine did
not meet the primary endpoint as assessed by the Yale Global Tic
Severity Scale (YGTSS) in children and adolescents with moderate to
severe Tourette syndrome. The types of treatment emergent
adverse events observed in this trial were consistent with those
seen in other valbenazine studies.
"We are very disappointed with the topline data from the T-Force
GOLD study given that children and adolescents with Tourette
syndrome need better treatment options. This study was
well-conducted with a placebo response as expected, but the
treatment effect of valbenazine was lower than we had anticipated,"
said Kevin Gorman, Ph.D., Chief
Executive Officer at Neurocrine Biosciences. "We would like to
thank the patients, caregivers and investigators for their
participation in this study. We will further analyze the data to
determine the next steps for valbenazine in Tourette syndrome."
Neurocrine Biosciences continues to focus on developing
treatments for neurological and endocrine related disorders. The
company discovered, developed and markets INGREZZA®
(valbenazine) capsules, the first U.S. Food and Drug Administration
(FDA) approved product indicated for the treatment of adults with
tardive dyskinesia, an involuntary movement disorder. In addition,
as part of a collaboration with AbbVie, ORILISSA™ (elagolix) was
approved in 2018 by the FDA for the treatment of endometriosis.
Other clinical development programs include opicapone for
Parkinson's disease patients, elagolix for uterine fibroids with
AbbVie and NBI-74788 for the treatment of congenital adrenal
hyperplasia (CAH).
Conference Call and Webcast Today at 8:30 a.m. Eastern Time
Neurocrine will
hold a live conference call and webcast today at 8:30 a.m. Eastern Time (5:30 a.m. Pacific Time). Participants can access
the live conference call by dialing 877-830-2589 (US) or
785-424-1052 (International) using the conference ID: NBIX. The
call can also be accessed via the webcast through the Company's
website at www.neurocrine.com.
T-Force GOLD Study Design
The T-Force GOLD study was a
multicenter, randomized, double-blind, placebo-controlled, parallel
group, Phase IIb study to evaluate the safety, tolerability and
efficacy of once-daily valbenazine capsules in 127 pediatric
patients with moderate to severe Tourette syndrome. Patients
received either once-daily dosing of valbenazine or placebo using a
1:1 randomization over 12 weeks of dosing followed by two weeks
off-drug. The first six weeks of the trial was a dose optimization
phase, with dose escalations allowed at week two or week four. The
primary endpoint of T-Force GOLD was the change from baseline of
the YGTSS Total Tic Score at week 12. The YGTSS is designed to rate
the overall severity of motor and phonic tic symptoms across a
range of dimensions: number, frequency, intensity, complexity and
interference.
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 dystonic 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 as part of a broader spectrum
diagnosis.
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 face,
torso, and/or other body parts.
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
Contraindications
INGREZZA is contraindicated in
patients with a history of hypersensitivity to valbenazine or any
components of INGREZZA. Rash, urticaria, and reactions consistent
with angioedema (e.g., swelling of the face, lips, and mouth) have
been reported.
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/PI.
About Neurocrine Biosciences, Inc.
Neurocrine Biosciences, a San
Diego based biopharmaceutical company, is focused on
developing treatments for neurological and endocrine related
disorders. The company discovered, developed and markets
INGREZZA® (valbenazine) capsules, the first FDA-approved
product indicated for the treatment of adults with tardive
dyskinesia, an involuntary movement disorder. Discovered and
developed through Phase II clinical trials by Neurocrine, ORILISSA™
(elagolix), the first FDA-approved oral medication for the
management of endometriosis with associated moderate to severe pain
in over a decade, is marketed by AbbVie as part of a collaboration
to develop and commercialize elagolix for women's health.
Neurocrine's clinical development programs include opicapone as an
adjunctive therapy to levodopa/DOPA decarboxylase inhibitors in
Parkinson's disease patients, elagolix for uterine fibroids with
AbbVie, valbenazine for the treatment of Tourette syndrome, and
NBI-74788 for the treatment of congenital adrenal hyperplasia
(CAH). For more information and the latest updates from Neurocrine
Biosciences, please visit 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 use of
valbenazine in patients with Tourette syndrome, the benefits to be
derived from INGREZZA in tardive dyskinesia and the continued
success of the launch of INGREZZA in tardive dyskinesia. Among the
factors that could cause actual results to differ materially from
those indicated in the forward-looking statements are: risks that
clinical development activities may be delayed for regulatory or
other reasons, may not be successful or replicate previous clinical
trial results, may fail to demonstrate that our product candidates
are safe and effective, or may not be predictive of real-world
results or of results in subsequent clinical trials; risks and
uncertainties associated with the commercialization of INGREZZA,
including the likelihood of continued revenue and prescription
growth of INGREZZA; risks and uncertainties relating to factors
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 precluded from
commercialization or continued commercialization by the proprietary
or regulatory 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, 2018. Neurocrine
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-announces-topline-data-from-phase-iib-t-force-gold-study-demonstrating-valbenazine-did-not-meet-primary-endpoint-in-pediatric-patients-with-tourette-syndrome-300763952.html
SOURCE Neurocrine Biosciences, Inc.