SAN DIEGO, May 18, 2017 /PRNewswire/ -- Neurocrine
Biosciences Inc. (NASDAQ: NBIX) announced today the upcoming
presentation at the American Psychiatric Association (APA) Annual
Meeting of pharmacokinetic data, as well as long-term data from the
KINECT 3 Phase III extension study of INGREZZA®
(valbenazine) capsules for the treatment of adults with TD.
"This year's annual meeting of the APA is an excellent
opportunity to present additional data and analyses from the
extensive clinical development program both supporting and
differentiating INGREZZA," said Chris
O'Brien, M.D., Chief Medical Officer of Neurocrine. "We are
particularly pleased to share this information with Psychiatrists
who now have access to the first and only FDA approved treatment
for TD patients."
The APA Annual Meeting is May 20-24,
2017, in San Diego,
CA. Neurocrine's oral presentation on Saturday, May 20, 2017 in a session from
8:00 a.m. – 11:00 a.m. PT is:
- 3047: New Horizons in Tardive Dyskinesia Research: Valbenazine
for Tardive Dyskinesia: Results from Two Randomized, Double-Blind,
Placebo-Controlled Trials
The four posters presented during New Research Posters 1 Session
on Monday, May 22, 2017 from
10:00 a.m. – 12:00 p.m. PT are:
- 8148: Efficacy of Valbenazine (NBI-98854) in Treating Subjects
with Tardive Dyskinesia and Mood Disorder
- 8152: Efficacy of Valbenazine (NBI-98854) in Treating Subjects
with Tardive Dyskinesia and Schizophrenia/Schizoaffective
Disorder
- 8150: Long-Term Safety and Tolerability of Valbenazine
(NBI-98854) in Subjects with Tardive Dyskinesia and a Diagnosis of
Schizophrenia or Mood Disorder
- 8082: Single Dose and Repeat Once-Daily Dose Safety,
Tolerability and Pharmacokinetics of Valbenazine in Healthy Male
Subjects
About Tardive Dyskinesia (TD)
TD is characterized by uncontrollable, abnormal and repetitive
movements of the trunk, extremities and/or face. The condition is
caused by 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
can 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 and only
product indicated for the treatment of adults with tardive
dyskinesia. The approval of INGREZZA was based on data from the
Kinect 3 study, a Phase III, randomized, double-blind,
placebo-controlled, parallel-group, fixed-dose study comparing
once-daily INGREZZA 80mg and 40mg to placebo over six weeks in
patients with underlying schizophrenia, schizoaffective disorder or
mood disorder. Subsequent to the completion of the six week
placebo-controlled dosing, all eligible subjects were placed on
once-daily 40mg or once-daily 80mg of INGREZZA through week 48.
INGREZZA met the primary endpoint in this study with a mean change
from baseline to week six in the AIMS dyskinesia total score of
-3.2 for the 80mg once-daily group as compared to -0.1 in the
placebo group (p <0.0001). Also in the Kinect 3 study:
- The percentage of participants who achieved at least a 50%
reduction in AIMS was 40.0 percent (p< 0.001) in participants
receiving 80mg/day of INGREZZA compared to only 8.7 percent of
those who received placebo.
- INGREZZA was found to be generally well tolerated, with
somnolence as the only adverse event occurring at a rate of 5
percent or greater and twice placebo.
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 TD. 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 together with
existing stable 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. In April of 2017, the
FDA approved INGREZZA® (valbenazine)
capsules for the treatment of adults with tardive dyskinesia
(TD). INGREZZA is a novel, selective vesicular monoamine
transporter 2 (VMAT2) inhibitor, and is the first and only
FDA-approved product indicated for the treatment of adults with
TD. The company markets INGREZZA in the United States. 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 (valbenazine), 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 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 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 precluded
from commercialization by 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 March 31,
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.