Acorda to Present Data at the 3rd Pan American Parkinson’s Disease and Movement Disorders Congress
12 February 2020 - 11:00PM
Business Wire
Acorda Therapeutics, Inc. (Nasdaq: ACOR) today announced that it
will present new data on INBRIJA® (levodopa inhalation powder) and
OFF Periods at the upcoming 3rd Pan American Parkinson’s Disease
and Movement Disorders Congress (MDS-PAS) taking place February
14-16, 2020 in Miami, FL.
The data include four posters that will be presented on
Saturday, February 15, 2020, from 1 – 2:30 PM ET:
- Poster #138 - CVT-301 utilization in clinical studies
- Poster #164 - Discussing OFF periods in Parkinson’s disease:
expert panel feedback
- Poster #167 - Pharmacokinetics (PK) of inhaled levodopa
co-administered with oral carbidopa in subjects with Parkinson’s
disease under fed conditions
- Poster #LBA-9 - Improvement in UPDRS motor scores after CVT-301
treatment is associated with improved scores in the Parkinson's
Disease Questionnaire activities of daily living
Acorda will also host a Corporate Therapeutics Symposium titled,
“Rethinking the Approach to Managing OFF Periods” on Saturday,
February 15, 2020 from 12:15 to 1:15 PM. The symposium will feature
a panel discussion on the practical considerations for the
recognition of OFF periods and the role of INBRIJA. Speakers will
include Peter A. LeWitt, MD, Director of the Parkinson’s Disease
and Movement Disorders Program at Henry Ford West Bloomfield
Hospital, Fernando Pagan, MD, Director of the Movement Disorders
Center at Georgetown University Hospital, and Mark Lew, MD, and
Director of the Division for Movement Disorders at Keck/USC School
of Medicine.
About Parkinson’s and OFF Periods
Parkinson’s is a progressive neurodegenerative disorder
resulting from the gradual loss of certain neurons in the brain.
These neurons are responsible for producing dopamine and that loss
causes a range of symptoms including impaired movement, muscle
stiffness and tremors. As Parkinson’s progresses, people are likely
to experience OFF periods, which are characterized by the return of
Parkinson’s symptoms, which can occur despite underlying baseline
therapy. Approximately one million people in the U.S. and 1.2
million Europeans are diagnosed with Parkinson’s; it is estimated
that approximately 40 percent of people with Parkinson’s in the
U.S. experience OFF periods.
About Acorda Therapeutics
Acorda Therapeutics develops therapies to restore function and
improve the lives of people with neurological disorders. INBRIJA is
approved for intermittent treatment of OFF episodes in adults with
Parkinson’s disease treated with carbidopa/levodopa. INBRIJA is not
to be used by patients who take or have taken a nonselective
monoamine oxidase inhibitor such as phenelzine or tranylcypromine
within the last two weeks. INBRIJA utilizes Acorda’s innovative
ARCUS® pulmonary delivery system, a technology platform designed to
deliver medication through inhalation. Acorda also markets the
branded AMPYRA® (dalfampridine) Extended Release Tablets, 10
mg.
Additional Important Safety Information for INBRIJA®
(levodopa inhalation powder)
- Patients treated with levodopa, the active ingredient in
INBRIJA, have reported falling asleep during activities of daily
living, including operation of motor vehicles, which sometimes
resulted in accidents. Many patients reported somnolence but some
reported no warning signs (sleep attack). This may occur more than
a year after initiating treatment. Reassess patients for
drowsiness/sleepiness including occurrence during specific
activities. Advise patients of potential for drowsiness and ask
about factors that may increase this risk (e.g., sedating
medications, sleep disorders).
- Consider discontinuing INBRIJA in patients who report
significant daytime sleepiness or falling asleep during activities
that require active participation. If continuing INBRIJA, advise
patients not to drive and to avoid activities that may result in
harm. There is insufficient information that dose reduction will
eliminate episodes of falling asleep during activities of daily
living.
- Neuroleptic malignant syndrome-like symptoms (e.g., elevated
temperature, muscular rigidity, altered consciousness, autonomic
instability) have been reported with rapid dose reduction,
withdrawal of, or changes in dopaminergic therapy.
- Hallucinations (with or without confusion, insomnia, and
excessive dreaming) may occur and may respond to reducing levodopa
therapy. Abnormal thinking and behavior may present with paranoid
ideation, delusions, hallucinations, confusion, psychotic-like
behavior, disorientation, aggressive behavior, agitation, and
delirium.
- INBRIJA should ordinarily not be used in patients with major
psychotic disorder due to risk of exacerbating psychosis. Dopamine
antagonists used to treat psychosis may exacerbate symptoms of PD
and may decrease INBRIJA efficacy.
- Patients on medications that increase central dopaminergic tone
such as INBRIJA can experience intense urges to gamble or spend
money, increased sexual urges, binge eating, and/or other intense
urges, and inability to control them. In some cases, these urges
stopped with dose reduction or medication discontinuation. Since
some patients may not recognize these behaviors as abnormal, ask
patients or their caregivers about development of new or increased
urges and consider stopping INBRIJA if this occurs.
- INBRIJA may cause or exacerbate dyskinesias. If troublesome
dyskinesias occur, consider stopping INBRIJA or adjusting other PD
medications.
- INBRIJA is not recommended in patients with asthma, COPD, or
other chronic underlying lung disease because of the risk of
bronchospasm.
- Monitor patients with glaucoma for increased intraocular
pressure.
- Abnormalities in laboratory tests may include elevations of
liver function tests (e.g., alkaline phosphatase, AST, ALT, lactic
dehydrogenase, bilirubin), blood urea nitrogen, hemolytic anemia,
and positive direct antibody test. Increased levels of
catecholamines and their metabolites in plasma and urine may result
in false-positive results suggesting pheochromocytoma.
- The most common adverse reactions (≥ 5% and > placebo) were
cough (15% vs 2%), upper respiratory tract infection (6% vs 3%),
nausea (5% vs 3%), and sputum discolored (5% vs 0%).
- Use of selective MAO-B inhibitors with INBRIJA may be
associated with orthostatic hypotension. Monitor patients taking
these drugs concurrently.
- Dopamine D2 receptor antagonists (e.g., phenothiazines,
butyrophenones, risperidone, metoclopramide) and isoniazid may
reduce levodopa efficacy; monitor for worsening symptoms.
- Iron salts or multivitamins with iron salts may reduce levodopa
bioavailability.
- INBRIJA should be used during pregnancy/nursing only if
potential benefit justifies potential risk. There are no adequate
data on INBRIJA in pregnant women or breastfed infants. Animal data
shows carbidopa/levodopa is developmentally toxic (including
teratogenicity). Levodopa may affect milk production, interfering
with lactation. Levodopa has been detected in human milk.
- Safety and effectiveness in pediatric patients have not been
established.
- Geriatric patients (n=56) experienced more of the following
adverse reactions than patients <65 (n=58): cough (25% vs 5%),
upper respiratory tract infection (11% vs 2%), nausea (7% vs 3%),
vomiting (4% vs 2%), pain in extremities (4% vs 0%), and discolored
nasal discharge (4% vs 0%).
Please see the accompanying Full Prescribing Information
available at www.INBRIJA.com/prescribing-information.PDF.
Forward-Looking Statement
This press release includes forward-looking statements. All
statements, other than statements of historical facts, regarding
management's expectations, beliefs, goals, plans or prospects
should be considered forward-looking. These statements are subject
to risks and uncertainties that could cause actual results to
differ materially, including: we may not be able to successfully
market Inbrija or any other products under development; we may need
to raise additional funds to finance our operations, repay
outstanding indebtedness or satisfy other obligations, and we may
not be able to do so on acceptable terms or at all; risks
associated with complex, regulated manufacturing processes for
pharmaceuticals, which could affect whether we have sufficient
commercial supply of Inbrija to meet market demand; third party
payers (including governmental agencies) may not reimburse for the
use of Inbrija or our other products at acceptable rates or at all
and may impose restrictive prior authorization requirements that
limit or block prescriptions; competition for Inbrija, Ampyra and
other products we may develop and market in the future, including
increasing competition and accompanying loss of revenues in the
U.S. from generic versions of Ampyra (dalfampridine) following our
loss of patent exclusivity; the ability to realize the benefits
anticipated from acquisitions, among other reasons because acquired
development programs are generally subject to all the risks
inherent in the drug development process and our knowledge of the
risks specifically relevant to acquired programs generally improves
over time; the risk of unfavorable results from future studies of
Inbrija (levodopa inhalation powder) or from our other research and
development programs, or any other acquired or in-licensed programs
; the occurrence of adverse safety events with our products; the
outcome (by judgment or settlement) and costs of legal,
administrative or regulatory proceedings, investigations or
inspections, including, without limitation, collective,
representative or class action litigation; failure to protect our
intellectual property, to defend against the intellectual property
claims of others or to obtain third party intellectual property
licenses needed for the commercialization of our products; and
failure to comply with regulatory requirements could result in
adverse action by regulatory agencies.
These and other risks are described in greater detail in our
filings with the Securities and Exchange Commission. We may not
actually achieve the goals or plans described in our
forward-looking statements, and investors should not place undue
reliance on these statements. Forward-looking statements made in
this press release are made only as of the date hereof, and we
disclaim any intent or obligation to update any forward-looking
statements as a result of developments occurring after the date of
this press release.
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version on businesswire.com: https://www.businesswire.com/news/home/20200212005031/en/
Tierney Saccavino (914) 326-5104 tsaccavino@acorda.com
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