Acorda Therapeutics Announces Commercial Launch of INBRIJA™ (levodopa inhalation powder)
February 28 2019 - 4:00PM
Business Wire
First and Only FDA-Approved Inhaled Levodopa
for On-demand Use for OFF Periods in People with Parkinson’s Taking
Carbidopa/Levodopa
Acorda Therapeutics, Inc. (NASDAQ: ACOR) today announced that
INBRIJA is now available by prescription in the United States.
INBRIJA was approved by the U.S. Food and Drug Administration (FDA)
on December 21, 2018 for intermittent treatment in people with
Parkinson’s taking carbidopa/levodopa who experience OFF
episodes.
“OFF periods are extremely disruptive for those living with
Parkinson’s. We are excited that INBRIJA is now available to
address this important unmet medical need, and that prescriptions
are already being filled,” said Ron Cohen, M.D., Acorda’s President
and CEO. “Our field sales and medical teams have been meeting with
Movement Disorder specialists to educate them about INBRIJA and our
Prescription Support Services center is available to help patients
and physicians’ offices navigate access and reimbursement.”
INBRIJA will be available through a network of specialty
pharmacies. Information about INBRIJA for healthcare professionals,
people with Parkinson’s and their care partners can be found at
www.INBRIJA.com. Through this site, physicians can access the
prescription request form and request a meeting with a sales
professional. In addition, Acorda’s Prescription Support Services
center is available to address questions from physicians and
patients from 8:00 a.m. ET to 8:00 p.m. ET at 1-888-887-3447.
About Acorda Therapeutics
Acorda Therapeutics develops therapies to restore function and
improve the lives of people with neurological disorders. INBRIJA™
(levodopa inhalation powder) 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 INBRIJATM (levodopa inhalation
powder)
INBRIJA is the first and only inhaled levodopa for intermittent
treatment of OFF episodes in patients with Parkinson’s disease
treated with carbidopa/levodopa. INBRIJA utilizes Acorda’s
innovative ARCUS® platform for inhaled therapeutics. A Marketing
Authorization Application (MAA) for INBRIJA was submitted to the
European Medicines Agency (EMA) in March 2018 and a final decision
from the European Commission is expected before the end of
2019.
Additional Important Safety Information
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 from a sleep
disorder or if they get drowsy/sleepy without warning or take a
medicine that increases sleepiness such as sleep medicines,
antidepressants, or antipsychotics
- feel dizzy, nausea, sweaty, or faint
when standing from sitting/lying down
- history of abnormal movement
(dyskinesia)
- mental health problem such as
hallucinations or psychosis
- uncontrollable urges (for example,
gambling, increased sexual urges, intense urges to spend 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), or isoniazid
- iron salts or multivitamins that
contain iron salts
No more than 1 dose (2 capsules) should be taken for any
OFF period. No more than 5 doses (10 capsules) of INBRIJA should be
taken in a day.
INBRIJA is for oral inhalation only. INBRIJA capsules are
not to be swallowed or opened.
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.
INBRIJA (levodopa inhalation powder) can cause serious side
effects including the following. Patients should tell their
healthcare provider if they experience them:
- falling asleep during normal daily
activities (such as driving, doing physical tasks, using
hazardous machinery, talking, or eating) and can be without
warning. If patients become drowsy while using INBRIJA, they should
not drive or do activities where they need to be alert. Chances of
falling asleep during normal activities increases if patients take
medicines that cause sleepiness.
- withdrawal-emergent hyperpyrexia and
confusion (symptoms including fever, confusion, stiff muscles,
and changes in breathing and heartbeat) in patients who suddenly
lower or change their dose or stop using INBRIJA or
carbidopa/levodopa medicines.
- low blood pressure with or
without dizziness, fainting, nausea, and sweating. Patients should
get up slowly after sitting or lying down.
- hallucinations and other
psychosis – INBRIJA may cause or worsen psychotic symptoms
including hallucinations (seeing/hearing 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; believing things that are not real, acting
aggressive, and feeling agitated/restless.
- unusual uncontrollable urges
such as gambling, binge eating, shopping, and sexual urges has
occurred in some people using medicines 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 call their healthcare provider
or go to the nearest hospital emergency room right away.
- 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.
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 Inbrija or any other products under development; 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; we may need to raise additional funds to finance our
operations and may not be able to do so on acceptable terms; 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/20190228005865/en/
MEDIATierney Saccavino(914)
326-5104tsaccavino@acorda.com
INVESTOR RELATIONSFelicia Vonella(914)
326-5146fvonella@acorda.com
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