Acorda Therapeutics to Present INBRIJA® Data at the American Academy of Neurology Annual Meeting
April 24 2023 - 8:00AM
Business Wire
Acorda Therapeutics, Inc. (Nasdaq: ACOR) today announced that it
will present data on INBRIJA (levodopa inhalation powder) and OFF
Periods at the American Academy of Neurology (AAN) Annual Meeting,
taking place in Boston from April 22 to April 27, 2023.
The poster, “Subgroup Analyses of Effect of Treatment With
Levodopa Inhalation Powder (CVT-301) 84 mg by Severity of OFF
Symptoms in People With Parkinson’s Disease, as Assessed by the
Unified Parkinson’s Disease Rating Scale Part III (UPDRS-III),”
will be presented on Tuesday, April 25.
DATE and TIME: Tuesday, April 25, 11:45AM – 12:45PM
LOCATION: Poster #017 in Neighborhood 11 SESSION: P8
Movement Disorders: Atypical Parkinsonisms 1
A virtual poster hall will be available on the AAN’s virtual
platform during the duration of the meeting and through May 15,
2023.
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.
About INBRIJA (levodopa inhalation powder) INBRIJA is the
first and only inhaled levodopa. It is a prescription medicine used
for the return of Parkinson’s symptoms (known as OFF episodes) in
adults treated with carbidopa/levodopa medicine. INBRIJA does not
replace regular carbidopa/levodopa medicine. 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 platform
for inhaled therapeutics.
Additional Important Safety Information (U.S.) Before
using INBRIJA, patients should tell their healthcare provider about
all their medical conditions, including:
- asthma, chronic obstructive pulmonary disease (COPD), or any
chronic lung disease
- daytime sleepiness, sleep disorders, sleepiness/drowsiness
without warning, or use of medicine that increases sleepiness
including antidepressants or antipsychotics
- dizziness, nausea, sweating, or fainting when standing up
- abnormal movement (dyskinesia)
- mental health problems such as hallucinations or psychosis
- uncontrollable urges like gambling, sexual urges, spending
money, or binge eating
- glaucoma
- pregnancy or plans to become pregnant. It is not known if
INBRIJA will harm an unborn baby.
- breastfeeding or plans to breastfeed. Levodopa (the medicine in
INBRIJA) can pass into breastmilk and it is unknown if it can harm
the baby.
Patients should tell their healthcare provider if they take:
- MAO-B inhibitors
- dopamine D2 receptor antagonists (including phenothiazines,
butyrophenones, risperidone, metoclopramide)
- isoniazid
- iron salts or multivitamins that contain iron salts
Patients are not to drive, operate machinery, or do other
activities until they know how INBRIJA affects them. Sleepiness and
falling asleep suddenly can happen as late as a year after
treatment is started.
Patients should tell their healthcare provider if they
experience the following side effects:
- falling asleep during normal daily activities with or
without warning. If patients become drowsy, they should not drive
or do activities where they need to be alert. Chances of falling
asleep during normal activities increases if patients take medicine
that cause sleepiness.
- withdrawal-emergent hyperpyrexia and confusion (fever,
stiff muscles, or changes in breathing and heartbeat) if patients
suddenly stop using INBRIJA or carbidopa/levodopa medicines, or
suddenly lower their dose of carbidopa/levodopa.
- low blood pressure when standing up (that may be with
dizziness, fainting, nausea, and sweating). Patients should get up
slowly after sitting or lying down.
- hallucinations and other psychosis – INBRIJA may cause
or worsen seeing/hearing/believing things that are not real;
confusion, disorientation, or disorganized thinking; trouble
sleeping; dreaming a lot; being overly suspicious or feeling people
want to harm them; acting aggressive, and feeling
agitated/restless.
- unusual uncontrollable urges such as gambling, binge
eating, shopping, and sexual urges has occurred in some people
using medicine like INBRIJA.
- uncontrolled, sudden body movements (dyskinesia) may be
caused or worsened by INBRIJA. INBRIJA may need to be stopped or
other Parkinson’s medicines may need to be changed.
- bronchospasm – people with asthma, COPD, or other lung
diseases may wheeze or have difficulty breathing after inhaling
INBRIJA. If patients have these symptoms, they should stop taking
INBRIJA and seek immediate medical attention.
- increased eye pressure in patients with glaucoma.
Healthcare providers should monitor this.
- changes in certain lab values including liver
tests.
The most common side effects of INBRIJA include cough, upper
respiratory tract infection, nausea, and change in the color of
saliva or spit.
No more than 1 dose (2 capsules) should be inhaled for any OFF
period. No more than 5 doses (10 capsules) of INBRIJA should be
used in a day.
Please see the accompanying Full Prescribing Information
available at www.INBRIJA.com/prescribing-information.PDF.
Forward-Looking Statements 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 AMPYRA, INBRIJA or any other products
under development; the COVID-19 pandemic, including related
restrictions on in-person interactions and travel, and the
potential for illness, quarantines and vaccine mandates affecting
our management, employees or consultants or those that work for
other companies we rely upon, could have a material adverse effect
on our business operations or product sales; our ability to attract
and retain key management and other personnel, or maintain access
to expert advisors; our ability to raise additional funds to
finance our operations, repay outstanding indebtedness or satisfy
other obligations, and our ability to control our costs or reduce
planned expenditures; risks associated with the trading of our
common stock; risks related to the successful implementation of our
business plan, including the accuracy of its key assumptions; risks
related to our corporate restructurings, including our ability to
outsource certain operations, realize expected cost savings and
maintain the workforce needed for continued operations; risks
associated with complex, regulated manufacturing processes for
pharmaceuticals, which could affect whether we have sufficient
commercial supply of INBRIJA or AMPYRA to meet market demand; our
reliance on third-party manufacturers for the timely production of
commercial supplies of INBRIJA and AMPYRA; third-party payers
(including governmental agencies) may not reimburse for the use of
INBRIJA or AMPYRA at acceptable rates or at all and may impose
restrictive prior authorization requirements that limit or block
prescriptions; reliance on collaborators and distributors to
commercialize INBRIJA and AMPYRA outside the U.S.; our ability to
satisfy our obligations to distributors and collaboration partners
outside the U.S. relating to commercialization and supply of
INBRIJA and AMPYRA; competition for INBRIJA and AMPYRA, 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 because, among other reasons,
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 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, except as may be required by law.
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version on businesswire.com: https://www.businesswire.com/news/home/20230424005261/en/
Tierney Saccavino (917) 783-0251 tsaccavino@acorda.com
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