SAN DIEGO, Oct. 1, 2019 /PRNewswire/ -- Neurocrine
Biosciences, Inc. (NASDAQ: NBIX) today announced it will present
data analyses evaluating the long-term effects of once-daily 40 mg
INGREZZA® (valbenazine) in adults with tardive
dyskinesia (TD), an involuntary movement disorder. A data analysis
will also be presented on the long-term effects of INGREZZA in
patients who demonstrated improvement in TD symptoms as early as
two weeks. In addition, Neurocrine Biosciences will present data on
the impact possible TD has on a patient's health-related quality of
life from RE-KINECT, the largest real-world screening study of
patients with clinician-confirmed possible TD. These data will be
presented at the 2019 Annual Psych Congress in San Diego, Oct. 3-6,
2019.
"We look forward to presenting data at Psych Congress which will
provide further insight into the long-term benefits of INGREZZA for
the treatment of tardive dyskinesia, including the effectiveness of
the 40 mg dose and the impact of early response to treatment," said
Eiry W. Roberts, M.D., Chief Medical Officer at Neurocrine
Biosciences. "These data provide important clinical information on
how INGREZZA can help to manage involuntary movements in patients,
and data from our real-world screening study can increase our
understanding of the social, physical and emotional impact these
movements may have on the everyday lives of patients."
INGREZZA is the first U.S. Food and Drug Administration (FDA)
approved treatment for adults with TD, a movement disorder that is
characterized by uncontrollable, abnormal and repetitive movements
of the face, torso and/or other body parts. The abnormal and
involuntary movements of TD can impact patients socially,
emotionally and physically, causing patients to feel embarrassed or
judged by others or withdraw from society and isolate
themselves.
The three Neurocrine-sponsored abstracts that will be presented
at the 2019 Annual Psych Congress are:
- Long-Term Treatment with Valbenazine 40 mg Once-Daily in
Adults with Tardive Dyskinesia
Poster #119, Poster Session,
Friday, Oct. 4, 1:30-2:30 p.m.
PT
- Early Response with Valbenazine and Long-Term Symptom
Reduction in Patients with Tardive Dyskinesia: Post Hoc Analysis of
the KINECT 3 Study
Poster #133, Poster Session, Friday, Oct. 4, 1:30-2:30 p.m. PT
- Health-Related Quality of Life in Patients with Possible
Tardive Dyskinesia: Results from the Real-World RE-KINECT
Study
Poster #247, Poster Session, Friday, Oct. 4, 1:30-2:30 p.m. PT
About Tardive Dyskinesia (TD)
Tardive dyskinesia (TD)
is a movement disorder that is characterized by uncontrollable,
abnormal and repetitive movements of the face, torso and/or other
body parts, which may be disruptive and negatively impact patients.
The condition is caused by prolonged use of 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® (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.
Parkinsonism
INGREZZA may cause parkinsonism in
patients with tardive dyskinesia. Parkinsonism has also been
observed with other VMAT2 inhibitors. Reduce the dose or
discontinue INGREZZA treatment in patients who develop clinically
significant parkinson-like signs or symptoms.
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 (Nasdaq: NBIX) is a neuroscience-focused,
biopharmaceutical company with more than 25 years of experience
discovering and developing life-changing treatments for people
with serious, challenging and under-addressed neurological,
endocrine and psychiatric disorders. The company's diverse
portfolio includes FDA-approved treatments for tardive dyskinesia
and endometriosis* and clinical development programs in multiple
therapeutic areas including Parkinson's disease, congenital adrenal
hyperplasia, uterine fibroids* and polycystic ovary
syndrome*. Headquartered in San
Diego, Neurocrine Biosciences specializes in targeting and
interrupting disease-causing mechanisms involving the
interconnected pathways of the nervous and endocrine
systems. For more information, visit neurocrine.com, and
follow the company on LinkedIn. (*in
collaboration with AbbVie)
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 by patients from INGREZZA. 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 the commercialization of 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 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 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 June 30, 2019.
Neurocrine disclaims any obligation to update the statements
contained in this press release after the date hereof.
View original content to download
multimedia:http://www.prnewswire.com/news-releases/neurocrine-biosciences-to-present-data-analyses-demonstrating-the-long-term-effectiveness-of-ingrezza-valbenazine-in-patients-with-tardive-dyskinesia-at-the-2019-annual-psych-congress-300929123.html
SOURCE Neurocrine Biosciences, Inc.