SAN DIEGO, Oct. 5, 2017 /PRNewswire/ -- Neurocrine
Biosciences, Inc. (NASDAQ: NBIX) announced today that the U.S. Food
and Drug Administration (FDA) has approved an 80 mg
INGREZZA® (valbenazine) capsule strength to
be used for the treatment of adults with tardive dyskinesia (TD).
INGREZZA, a novel, selective vesicular monoamine transporter 2
(VMAT2) inhibitor, which was approved by the FDA April 11, 2017, is the first FDA-approved product
indicated for the treatment of adults with TD.
"INGREZZA continues to be the TD treatment of choice," said
Kevin C. Gorman, Chief Executive
Officer of Neurocrine Biosciences. "With the approval of the new 80
mg capsule, patients now have access to an even more convenient
treatment option. INGREZZA is the only TD therapy to offer
simplified dosing with only one capsule once per day."
Clinical studies have shown that INGREZZA 80 mg provided
significant, rapid, and meaningful improvement in TD severity
compared to placebo at 6 weeks (-3.2 vs -0.1; P values less than or
equal to 0.001) with separation seen as early as two weeks, and
continued reductions observed through 48 weeks of treatment.
INGREZZA was generally well tolerated, with somnolence as the only
adverse event occurring at a rate greater than or equal to 5
percent and twice placebo. In clinical trials, generally no
worsening in safety scale scores for depression, suicidal ideation
or behaviors was observed. INGREZZA has been studied in over 1,000
individuals and more than 20 clinical trials.
The 80 mg capsule of INGREZZA will be available for patients
within two weeks through a select pharmacy network. To assist
patients living with TD obtain access to INGREZZA, Neurocrine
created the INBRACETM patient support program, which
accepts treatment initiation forms from health care professionals
prescribing INGREZZA and works closely with patients and their
families to facilitate access. INBRACE is also designed to provide
personalized product assistance and services. For more information,
patients may visit www.INGREZZA.com or call 1-84-INGREZZA
(1-844-647-3992).
About Tardive Dyskinesia (TD)
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
INGREZZA, a selective VMAT2 inhibitor, is the first FDA approved
product indicated for the treatment of adults with tardive
dyskinesia. INGREZZA inhibits VMAT2 and 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 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 (greater than or equal to 5%
and twice the rate of placebo) is somnolence. Other adverse
reactions (greater than or equal to 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.
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 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 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 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.