Acorda Therapeutics, Inc. (Nasdaq: ACOR) today announced that it
has launched a new INBRIJA (levodopa inhalation powder) website and
brand campaign. The campaign, “For the Fighters,” is based on
direct feedback from people with Parkinson’s (PwPs). It honors the
fighting spirit of the Parkinson’s community, encouraging PwPs to
step up their fight by considering whether an on-demand treatment
for OFF periods, such as INBRIJA, is right for them.
The campaign can be viewed at www.Inbrija.com.
INBRIJA is an inhaled prescription levodopa medicine used to
treat the return of Parkinson’s symptoms (known as OFF episodes) in
people with Parkinson’s disease who are treated with
carbidopa-levodopa medicines. It does not replace the regular
carbidopa-levodopa medicines. INBRIJA is not to be used by people
who have taken a nonselective monoamine oxidase inhibitor, such as
phenelzine or tranylcypromine, within the last 2 weeks.
“Our message to our Parkinson’s community is ‘we see you, and we
see fighters.’ We want this campaign to reflect the strength, the
determination, and grit that people with Parkinson’s bring to their
fight against this disease,” said Kerry Clem, Chief Commercial
Officer at Acorda. “We’ve heard from many people living with
Parkinson’s, as well as their care partners, that when their
symptoms return between doses of their regular medication it can
cause them to avoid going out or making plans, and they may miss
some of the important moments in their lives. Therefore, it’s
important for people with Parkinson’s to have access to on-demand
treatment options, such as INBRIJA, to address these OFF periods
when and where they occur*.”
“We’re proud to be able to bring an on-demand, rescue treatment
to PwPs to help address OFF periods,” said Ron Cohen, M.D.,
Acorda’s President and Chief Executive Officer. “In addition, now
that there are fewer on-demand therapies available, we are
redoubling our efforts to provide this community with education and
support, so that people living with Parkinson’s can continue their
fight. These efforts are building on the success of the INBRIJA
commercial that we launched this spring.”
Jimmy Gaddis, one of Acorda’s Inbrija ambassadors, added: “I’ve
lived with Parkinson’s for over 16 years, so this message really
hits home for me. I’m determined to make every day, every moment,
count, and to live a full life with my family and friends. I look
for whatever tools or options will help me in this fight, whether
it’s exercise, healthy eating, social activities, or on-demand
treatment options.”
Additional Important Safety Information
Before using INBRIJA, tell your healthcare provider about your
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 unknown if INBRIJA
will harm an unborn baby.
- breastfeeding or plans to breastfeed. Levodopa can pass into
breastmilk and it is unknown if it can harm the baby.
Tell your healthcare provider if you take:
- MAO-B inhibitors
- dopamine (D2) antagonists (including phenothiazines,
butyrophenones, risperidone, metoclopramide)
- isoniazid
- iron salts or multivitamins that contain iron salts
Do not drive, operate machinery, or do other activities until
you know how INBRIJA affects you. Sleepiness and falling asleep
suddenly can happen as late as a year after treatment is
started.
Tell your healthcare provider if you experience the following
side effects:
- falling asleep during normal daily activities with or without
warning. If you become drowsy, do not drive or do activities where
you need to be alert. Chances of falling asleep during normal
activities increases if you take medicine that causes
sleepiness.
- withdrawal-emergent hyperpyrexia and confusion (fever, stiff
muscles, or changes in breathing and heartbeat) if you suddenly
stop using INBRIJA or carbidopa/levodopa, or suddenly lower your
dose of carbidopa/levodopa.
- low blood pressure when standing up (that may be with
dizziness, fainting, nausea, and sweating). Get up slowly after
sitting/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 you; 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
this occurs, stop taking INBRIJA and seek immediate medical
attention.
- increased eye pressure in patients with glaucoma. Your
healthcare provider should monitor this.
- changes in certain lab values including liver tests
The most common side effects of INBRIJA are cough, upper
respiratory tract infection, nausea, and change in the color of
saliva or spit.
Do not orally inhale more than 1 dose (2 capsules) for any OFF
period. Do not take more than 5 doses (10 capsules) in a day.
*Please see the Patient Information Leaflet and
Instructions For Use at www.inbrija.com.
Please see Full Prescribing Information here.
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.
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 INBRIJA, AMPYRA 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; the
reverse stock split and its impact on 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/20230802544540/en/
Tierney Saccavino (917) 783-0251 tsaccavino@acorda.com
Acorda Therapeutics (NASDAQ:ACOR)
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