SAN DIEGO, Oct. 16, 2021 /PRNewswire/ -- Neurocrine
Biosciences, Inc. (Nasdaq: NBIX) today announced that it will
present key information from its movement disorder treatments for
Parkinson's disease and tardive dyskinesia (TD) at the American
Neurological Association (ANA) 2021 Virtual Annual Meeting being
held October 17–19, 2021.
Neurocrine Biosciences will present new post-hoc analysis of
pooled data from the ONGENTYS® (opicapone) BIPARK-1 and
BIPARK-2 Phase 3 studies evaluating nighttime "off" episodes in
people with Parkinson's disease and motor fluctuations. The
analysis found that a high percentage of study participants prior
to initiation of therapy experienced "off" time before sleep, had
an awake period in an "off" state at night after falling asleep, or
awoke in the morning in an "off" state. Key insights from this
analysis provide a better understanding of the effect of wearing
"off" time on sleep and the importance of addressing nighttime
"off" episodes in people living with Parkinson's disease.
"We continue to conduct new analyses and share new insights
for INGREZZA and ONGENTYS that not only describe the impact of
treatment on disease, but also enable us to better understand the
real-life experiences of people living with tardive dyskinesia or
Parkinson's disease and the impact of these disorders on their
everyday life," said Eiry W. Roberts, M.D., Chief Medical Officer
at Neurocrine Biosciences. "The information presented
here underscores our ongoing commitment to help improve the
lives of people living with neurological disorders."
Presentations include:
ONGENTYS – Parkinson's Disease (in collaboration
with BIAL)
- Off-time
and sleep in Patients with Parkinson's Disease and Motor
Fluctuations
(Poster # 172)
- Effects of
Once-Daily Opicapone 50 mg on the Pharmacokinetics of Levodopa
Administered as Carbidopa/Levodopa Extended-Release Capsules: An
Open-Label Phase 1 Study (Poster # 157)
- Evaluating
Patients' Preferences for Parkinson's Disease Treatments (Poster #
165)
- OPTI-ON: A
Longitudinal Real-World Study of Opicapone in Patients with
Parkinson's Disease and Motor Fluctuations (Poster # 158)
- Treatment
Patterns in a Real-World Sample of Patients with Parkinson's
Disease and Motor Fluctuations (Poster # 168)
INGREZZA – Tardive Dyskinesia
- Patterns of
Improvement in Tardive Dyskinesia: Post-Hoc Analysis of a Long-Term
Study with Valbenazine - KINECT 4 (Poster # 159)
- What's Next
for Tardive Dyskinesia? Experts Insights from a Cross-Disciplinary
Virtual Treatment Panel (Poster # 162)
A full list of all abstracts being presented by Neurocrine
Biosciences at the ANA 2021 Virtual Annual Meeting are available
here.
About Parkinson's Disease
Parkinson's disease is a
chronic, progressive and debilitating neurodegenerative disorder
that affects approximately 1 million people in the
U.S. and 6 million people worldwide. Parkinson's disease is
associated with low dopamine levels produced in the brain. Dopamine
helps transmit signals between the areas of the brain that control
all purposeful movements, including talking, walking and writing.
As Parkinson's disease progresses, dopamine production steadily
decreases, resulting in increased problems with motor symptoms
including slowed movement (bradykinesia), tremor, rigidity,
impaired posture and balance, and difficulty with speech and
writing.
There is presently no cure for Parkinson's disease and
management of the disease consists of the use of treatments that
attempt to control motor symptoms primarily through dopaminergic
mechanisms. The current gold standard for treatment of motor
symptoms is levodopa/carbidopa. While levodopa/carbidopa improves
patients' motor symptoms, as the disease progresses, the beneficial
effects of levodopa begin to wear off more quickly. Patients then
experience motor fluctuations throughout the day between "on" time,
periods when the medication is working and Parkinson's disease
symptoms are controlled, and "off" time, when the medication is not
working and motor symptoms return.
About ONGENTYS® (opicapone)
Capsules
ONGENTYS is a once-daily, oral, peripheral,
selective and reversible catechol-O-methyltransferase (COMT)
inhibitor approved by the U.S. Food and Drug
Administration (FDA) as an add-on treatment to
levodopa/carbidopa in patients with Parkinson's disease
experiencing "off" episodes. ONGENTYS inhibits the COMT enzyme,
which breaks down levodopa, making more levodopa available to reach
the brain.
In June 2016, BIAL – Portela & CA,
S.A. (BIAL) received approval from the European
Commission for ONGENTYS as an adjunct therapy to preparations of
levodopa/DOPA decarboxylase inhibitors in adult patients with
Parkinson's disease and end-of-dose motor fluctuations who cannot
be stabilized on those combinations. BIAL currently
markets ONGENTYS in several European
countries. Neurocrine Biosciences in-licensed opicapone
from BIAL in 2017 and has exclusive development and
commercialization rights in the U.S. and Canada.
Important Information
Approved Use
ONGENTYS® (opicapone)
capsules is a prescription medicine used with levodopa and
carbidopa in people with Parkinson's disease (PD) who are having
"OFF" episodes.
It is not known if ONGENTYS is safe and effective in
children.
Important Safety Information
Do not take ONGENTYS
if you:
- take a type of medicine called a non-selective
monoamine-oxidase (MAO) inhibitor.
- have a tumor that secretes hormones known as
catecholamines.
Before taking ONGENTYS, tell your healthcare provider about
all of your medical conditions, including if you :
- have daytime sleepiness from a sleep disorder, have unexpected
periods of sleep or sleepiness, or take a medicine to help you
sleep or that makes you feel sleepy.
- have had intense urges or unusual behaviors, including
gambling, increased sex drive, binge eating, or compulsive
shopping.
- have a history of uncontrolled sudden movements
(dyskinesia).
- have had hallucinations or psychosis.
- have liver or kidney problems.
- are pregnant or plan to become pregnant, or are breastfeeding
or plan to breastfeed.
Tell your healthcare provider about all the medicines you
take , including prescription and over-the-counter
medicines, vitamins, and herbal supplements. Especially tell
your healthcare provider if you take nonselective MAO inhibitors
(such as phenelzine, tranylcypromine, and isocarboxazid) or
catecholamine medicines (such as isoproterenol, epinephrine,
norepinephrine, dopamine, and dobutamine), regardless of how you
take the medicine (by mouth, inhaled, or by injection).
ONGENTYS and other medicines may affect each other causing side
effects. ONGENTYS may affect the way other medicines work, and
other medicines may affect how ONGENTYS works.
What should I avoid while taking ONGENTYS?
Do not
drive, operate machinery, or do other dangerous activities until
you know how ONGENTYS affects you.
What are the possible side effects of ONGENTYS?
ONGENTYS may cause serious side effects, including:
- Falling asleep during normal activities such as driving
a car, talking or eating while taking ONGENTYS or other medicines
used to treat Parkinson's disease, without being drowsy or without
warning. This may result in having accidents. Your chances of
falling asleep while taking ONGENTYS are higher if you take other
medicines that cause drowsiness.
- Low blood pressure or dizziness, light headedness, or
fainting.
- Uncontrolled sudden movements (dyskinesia). ONGENTYS may
cause uncontrolled sudden movements or make such movements worse or
happen more often.
- Seeing, hearing, or feeling things that are not real
(hallucinations), believing things that are not real
(delusions), or aggressive behavior.
- Unusual urges (impulse control and compulsive disorders)
such as urges to gamble, increased sexual urges, strong urges to
spend money, binge eating, and the inability to control these
urges.
Tell your healthcare provider if you experience any of these
side effects or notice changes in your behavior.
The most common side effects of ONGENTYS
include uncontrolled sudden movements (dyskinesia),
constipation, increase in an enzyme called blood creatine kinase,
low blood pressure, and weight loss.
These are not all of the possible side effects of ONGENTYS. Call
your healthcare provider for medical advice about side effects. You
may report side effects to FDA at 1-800-FDA-1088.
Please see ONGENTYS full Product Information.
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 associated with taking certain kinds of mental
health medicines (like antipsychotics) that help control dopamine
receptors in the brain. Antipsychotics commonly prescribed to treat
mental illnesses such as depression, bipolar disorder,
schizophrenia and schizoaffective disorder, and certain medications
to treat upset stomach, nausea and vomiting may also cause TD. 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 approximately 600,000
people in the U.S.
About INGREZZA® (valbenazine)
Capsules
INGREZZA, a selective vesicular monoamine transporter 2 (VMAT2)
inhibitor, is an 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 by Neurocrine Biosciences,
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 most
psychiatric medications such as antipsychotics or
antidepressants.
Important Information
Approved Use
INGREZZA® (valbenazine) capsules is a
prescription medicine used to treat adults with movements in the
face, tongue, or other body parts that cannot be controlled
(tardive dyskinesia).
It is not known if INGREZZA is safe and effective in
children.
IMPORTANT SAFETY INFORMATION
Do not take INGREZZA if you:
- are allergic to valbenazine, or any of the ingredients in
INGREZZA.
INGREZZA may cause serious side effects,
including:
- Sleepiness (somnolence). Do not drive, operate heavy
machinery, or do other dangerous activities until you know how
INGREZZA affects you.
- Heart rhythm problems (QT prolongation). INGREZZA may
cause a heart problem known as QT prolongation.
Symptoms of QT prolongation may include:
• fast, slow, or
irregular heartbeat
|
• shortness of
breath
|
• dizziness or
fainting
|
|
- Tell your healthcare provider right away if you have a
change in your heartbeat (a fast or irregular heartbeat), or if you
faint.
- Abnormal movements (Parkinson-like). Symptoms include:
shaking, body stiffness, trouble moving or walking, or keeping your
balance.
Before taking INGREZZA, tell your healthcare provider about
all of your medical conditions including if
you: have liver or heart problems, are pregnant or plan to
become pregnant, or are breastfeeding or plan to
breastfeed.
Tell your healthcare provider about all the medicines you
take, including prescription and over-the-counter medicines,
vitamins and herbal supplements.
The most common side effect of INGREZZA is sleepiness
(somnolence). Other side effects include changes in balance
(balance problems, dizziness) or an increased risk of falls,
headache, feelings of restlessness, dry mouth, constipation, and
blurred vision.
These are not all of the possible side effects of INGREZZA. Call
your doctor for medical advice about side effects. You may report
side effects to FDA at 1-800-FDA-1088.
Please see accompanying INGREZZA full Product
Information.
About Neurocrine Biosciences
Neurocrine
Biosciences is a neuroscience-focused, biopharmaceutical
company dedicated to discovering, developing and delivering
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, Parkinson's disease, endometriosis*,
uterine fibroids* and clinical programs in multiple therapeutic
areas. For nearly three decades, Neurocrine
Biosciences has specialized 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 from Neurocrine's products and product candidates.
Among the factors that could cause actual results to differ
materially from those indicated in the forward-looking statements
are: our future financial and operating performance; risks
associated with the commercialization of INGREZZA and ONGENTYS; the
impact of the COVID-19 pandemic and efforts to mitigate its spread
on our business; risks and uncertainties associated with the scale
and duration of the COVID-19 pandemic and resulting global,
national, and local economic and financial disruptions; risks
related to the development of our product candidates; risks
associated with our dependence on third parties for development and
manufacturing activities related to INGREZZA and our product
candidates, and our ability to manage these third parties; risks
that the FDA or other regulatory authorities may make adverse
decisions regarding our products or product candidates; risks that
our products, and/or our product candidates may be precluded from
commercialization by the proprietary or regulatory rights of third
parties, or have unintended side effects, adverse reactions or
incidents of misuse; risks associated with potential generic
entrants for our products; risks associated with our dependence on
BIAL for manufacturing activities for ONGENTYS, and our ability to
manage BIAL; risks that clinical development activities may not be
completed on time or at all, or may be delayed for regulatory,
manufacturing, COVID-19 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 the potential benefits of the
agreements with our collaboration partners may never be realized;
and other risks described in our periodic reports filed with the
SEC, including without limitation our quarterly report on Form 10-Q
for the quarter ended June 30, 2021.
Neurocrine disclaims any obligation to update the statements
contained in this press release after the date hereof.
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SOURCE Neurocrine Biosciences, Inc.