SAN DIEGO, Sept. 15, 2017 /PRNewswire/ -- Neurocrine
Biosciences Inc. (NASDAQ: NBIX) announced today upcoming poster
presentations at the 2017 Annual Psych Congress featuring data from
the RE-KINECT study outlining the real-world presence and impact of
tardive dyskinesia (TD) on the lives of both patients and
caregivers. Neurocrine will also present four posters regarding
INGREZZA® (valbenazine) capsules, the first FDA-approved
treatment for adults with tardive dyskinesia, including data on the
effects of INGREZZA on tardive dyskinesia (TD) in different body
regions and the safety profile of INGREZZA with respect to
metabolic parameters.
"This year's Psych Congress
serves as an excellent opportunity to dive deeper into the patient
impact of TD, including demographics and healthcare utilization.
The RE-KINECT study provides valuable insight into the complexities
and needs of these patients and how INGREZZA can address the
movements that may disrupt patient lives," said Chris O'Brien, M.D., Chief Medical Officer of
Neurocrine. "We look forward to sharing this research with the
community. Now that practicing physicians have access to an FDA
approved treatment for tardive dyskinesia, it is important that we
work toward a more in-depth understanding of the condition and
patient experience."
The Psych Congress Annual Meeting is September 16-19, 2017, in New Orleans, Louisiana. Neurocrine's
seven posters will be presented during the poster sessions on
Sunday, September 17, 2017 from 1:30
– 2:30 pm ET and 5:30 – 7:30 pm ET, as well as Monday, September 18, 2017 from 1:30 –
2:30 pm ET:
- 227: Demographics and Real World Healthcare Utilization for
Patients with Probable Tardive Dyskinesia
- 228: Evaluation of Potential Drug Interactions with
Valbenazine
- 229: Tardive Dyskinesia: Patient and Caregiver Perspectives on
Signs, Symptoms, and Impact
- 230: Effects of Once-Daily Valbenazine on Tardive Dyskinesia by
Body Region as Measured by the Abnormal Involuntary Movement
Scale
- 231: Effects of Once-Daily Valbenazine on Metabolic Parameters
in Adults with Tardive Dyskinesia
- 243: RE-KINECT: A Prospective Real-World Dyskinesia Screening
Study and Registry in Patients Taking Antipsychotic Agents: Patient
Demographics
- 244: Estimation of an MCID for AIMS Total Score Change in
Tardive Dyskinesia
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 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 once-daily, and 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) 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.