SAN DIEGO, April 21, 2017 /PRNewswire/ -- Neurocrine
Biosciences, Inc. (NASDAQ: NBIX) announced today that long-term
safety and efficacy data from the KINECT 3 Phase III extension
study of INGREZZA™ (valbenazine) capsules for the
treatment of adults with tardive dyskinesia will be presented as a
platform presentation at the American Academy of Neurology (AAN)
Annual Meeting April 22-28, 2017 in
Boston. Additionally, two posters
representing additional data from several clinical trials of
INGREZZA will be presented, including an analysis of its
pharmacologic characteristics.
"We are very pleased to present additional robust data from the
largest ever clinical program in tardive dyskinesia at this year's
American Academy of Neurology Annual Meeting," said Chris O'Brien, M.D., FAAN, Chief Medical Officer
at Neurocrine. "Over 1,000 persons have participated in more than
20 INGREZZA clinical trials, with consistent and strong results
demonstrated by the first and only FDA-approved treatment for
adults with tardive dyskinesia. These expanded safety, efficacy and
pharmacologic findings continue to illustrate INGREZZA's
differentiated potential and what it offers to an underserved
community."
The two posters presented during Poster Session II on
Monday, April 24, 2017 are:
- P2.017: Safety and Tolerability of Valbenazine (NBI-98854) in
Subjects with Tardive Dyskinesia: Results of Long-Term Exposure
Data from Three Studies
- P2.025: Pharmacologic Characteristics of Valbenazine
(NBI-98854) and its Metabolites
The platform presentation during the Movement Disorders:
Huntington's Disease and
Drug-Induced Dyskinesias Session on Friday,
April 28, 2017 (3:30p to 5:30p) at 4:18 pm ET includes:
- S56.005: Efficacy of Valbenazine (NBI-98854) in Subjects with
Tardive Dyskinesia: Results of a Long-Term Study (KINECT 3
Extension)
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
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. We market 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 Neurocrine's
products and product candidates, including 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 or the development of the
Company's product candidates; 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; risks that the Company will be unable to raise
additional funding, if required, to complete development of its
product candidates or to commercialize INGREZZA; and other risks
described in the Company's periodic reports filed with the
Securities and Exchange Commission, including without limitation
the Company's Annual Report on Form 10-K for the year ended
December 31, 2016. 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.