SAN DIEGO, Sept. 28, 2020 /PRNewswire/ -- Neurocrine
Biosciences, Inc. (Nasdaq: NBIX) today announced it will present
data analyses evaluating the efficacy and safety of
ONGENTYS® (opicapone) capsules, recently approved by the
U.S. Food and Drug Administration (FDA) as the first and only
once-daily catechol-O-methyltransferase (COMT) inhibitor as an
add-on to levodopa/carbidopa in patients with Parkinson's disease
experiencing "off" episodes. New data from a post-hoc, sub-group
analysis of Phase III data showed that ONGENTYS led to greater
reductions in overnight "off" time and time to morning "on" time
compared to entacapone in patients with Parkinson's disease with
motor fluctuations. In another Phase III post-hoc sub-group
analysis, long-term use of ONGENTYS in patients with Parkinson's
disease with motor fluctuations reduced "on" time with
troublesome dyskinesia and increased good "on" time without
troublesome dyskinesia. In this analysis, long-term use of ONGENTYS
was associated with a reduction in the patient's average daily
levodopa dosage requirement. These data will be presented in
collaboration with BIAL at the American Neurological
Association (ANA) 2020 Virtual Meeting on October 4–9, 2020.
"As Parkinson's disease progresses and the benefit of treatment
with levodopa/carbidopa begins to wear off between doses, many
patients experience increased fluctuation and unpredictability in
their motor function, which can include more 'off' time overnight
and during the day, and a reduction in good 'on' time where
movement is close to normal," said Eiry W. Roberts, M.D., Chief
Medical Officer at Neurocrine Biosciences. "These post-hoc analyses
from the Phase III clinical trials of ONGENTYS provide further
insight on how adding once-daily ONGENTYS to levodopa/carbidopa can
help patients with Parkinson's disease better manage disruptive
motor fluctuations over the course of the day."
The six ONGENTYS abstracts that will be presented at the ANA
2020 Virtual Meeting are:
- Long-Term Efficacy of Opicapone in the Reduction of ON-Time
with Troublesome Dyskinesia in Parkinson's Disease Patients with
Motor Fluctuations and Reporting Troublesome Dyskinesia (Poster
#489)
- Effects of Once-Daily Opicapone on Duration of Overnight OFF
and Time to Morning ON in Patients with Parkinson's Disease and
Motor Fluctuations (Poster #494)
- Efficacy of Opicapone at Different Levodopa Regimens up to a
Threshold of 600 mg/day Levodopa in Parkinson's Disease Patients
with Motor Fluctuations (Poster #490)
- Effect of Opicapone and Entacapone on Early Morning-OFF Pattern
in Parkinson's Disease Patients with Motor Fluctuations (Poster
#477)
- Characterization of the Pattern of Daily Motor Fluctuations in
Parkinson's Disease Patients Based on Home Diaries (Poster
#493)
- Onset of Drug-Related Adverse Events in Parkinson's Disease
Patients with Motor Fluctuations Treated with Opicapone in Clinical
Practice: OPTIPARK Post-Hoc Analysis (Poster #485)
About Parkinson's Disease
Parkinson's disease is a
chronic, progressive and debilitating neurodegenerative disorder
that affects approximately one million people in the United States and six million people
worldwide. Parkinson's disease is caused by 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 unique, 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 Germany, United
Kingdom, Spain, Portugal and Italy. 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 Neurocrine Biosciences
Neurocrine
Biosciences is a neuroscience-focused, biopharmaceutical company
with 28 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, Parkinson's disease, endometriosis* and
uterine fibroids*, with three pivotal and five mid-stage clinical
programs in multiple therapeutic areas. 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 from ONGENTYS; and the continued success of the
launch of ONGENTYS; our expectations regarding business and
financial impacts of the COVID-19 pandemic, including with respect
to ONGENTYS availability and the ONGENTYS commercial supply chain
and other business operations; and whether results from ONGENTYS's
clinical trial results 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 the scale and duration of the
COVID-19 pandemic and resulting global, national, and local
economic and financial disruptions; risk and uncertainties related
to any COVID-19 quarantines, shelter-in-place and similar
government orders that are currently in place or that may be put in
place in the future, including the impact of such orders on our
business operations and the business operations of the third
parties on which we rely; risks and uncertainties associated with
Neurocrine Biosciences' business and finances in general, as well
as risks and uncertainties associated with the commercialization of
ONGENTYS; whether ONGENTYS receives adequate reimbursement from
third-party payors; the degree and pace of market uptake of
ONGENTYS; risks and uncertainties relating to competitive products
and technological changes that may limit demand for ONGENTYS; risks
that additional regulatory submissions, for ONGENTYS or other
product candidates, may not occur or be submitted in a timely
manner; risks that the FDA or other regulatory authorities may make
adverse decisions regarding ONGENTYS; risks that post-approval
ONGENTYS commitments or requirements may be delayed; risks that
ONGENTYS may be precluded from commercialization or continued
commercialization by the proprietary rights of third parties, or
have unintended side effects, adverse reactions or incidents of
misuse; risks and uncertainties relating to competitive products
and technological changes that may limit demand for ONGENTYS; risks
associated with the Company's dependence on BIAL for the commercial
supply of, and manufacturing activities related to, ONGENTYS, and
the ability of the Company to manage BIAL; 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, 2020. 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-new-data-analyses-of-once-daily-ongentys-opicapone-in-patients-with-parkinsons-disease-at-the-american-neurological-association-2020-virtual-meeting-301139245.html
SOURCE Neurocrine Biosciences, Inc.