First and Only FDA-Approved Inhaled Levodopa for On-demand Use for OFF
Periods in People with Parkinson’s Taking Carbidopa/Levodopa
ARDSLEY, N.Y.–(BUSINESS WIRE)–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
“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
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
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
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
- 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)
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
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
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
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
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.
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.