Acorda Therapeutics, Inc. (NASDAQ: ACOR) today announced that
the European Medicines Agency’s (EMA) Committee for Medicinal
Products for Human Use (CHMP) issued a positive opinion
recommending INBRIJA’s approval by the European Commission (EC).
The recommended indication is: Inbrija is indicated for the
intermittent treatment of episodic motor fluctuations (off
episodes) in adult patients with Parkinson’s disease (PD) treated
with a levodopa/dopa-decarboxylase inhibitor. The European
Commission (EC) will now consider the CHMP positive opinion in its
decision of whether to grant marketing authorization for INBRIJA in
Europe; the final EC decision is expected in the coming months. The
review of this application is being conducted under the centralized
licensing procedure, and the final decision will be applicable in
all 28 member states of the European Union, as well as Iceland,
Liechtenstein and Norway.
INBRIJA was approved by the U.S. Food and Drug Administration on
December 21, 2018 for the intermittent treatment of OFF episodes
(also known as OFF periods) in people with Parkinson’s disease
treated with carbidopa/levodopa.
“We are delighted that INBRIJA has achieved this important
milestone, and look forward to the EC’s final decision later this
year. There are approximately 1.2 million people in the EU living
with Parkinson’s. We estimate that 40% of these individuals
experience OFF periods, which are considered extremely disruptive,”
said Ron Cohen, M.D., Acorda’s President and CEO. “Acorda is
currently evaluating partnering opportunities to commercialize
INBRIJA in Europe.”
The positive CHMP decision is based on a clinical program for
INBRIJA that included approximately 900 people with Parkinson’s on
a levodopa/dopa-decarboxylase inhibitor regimen experiencing OFF
periods. The results of the Phase 3 pivotal efficacy trial –
SPANSM-PD – were published in The Lancet Neurology.
SPAN-PD was a 12-week, randomized, placebo controlled, double
blind study evaluating the effectiveness of INBRIJA in patients
with mild to moderate Parkinson’s experiencing OFF periods.
The SPAN-PD trial met its primary endpoint, with patients
showing a statistically significant improvement in motor function
at the Week 12 visit, as measured by a reduction in Unified
Parkinson’s Disease Rating Scale (UPDRS) Part III score for INBRIJA
84 mg (n=114) compared to placebo (n=112) at 30 minutes post-dose
(-9.83 points and -5.91 points respectively; p=0.009). Onset of
action was seen as early as 10 minutes.
The most common adverse reactions with INBRIJA (at least 5% and
greater than placebo) in this pivotal trial were cough (15% vs.
2%), upper respiratory tract infection (6% vs. 3%), nausea (5% vs.
3%) and sputum discolored (5% vs. 0%).
INBRIJA was also studied in a Phase 3 long-term,
active-controlled, randomized, open-label study (N=398) assessing
safety and tolerability over one year. This study showed the
average reduction in FEV1 (forced expiratory volume in 1 second)
from baseline was the same (-0.1 L) for the INBRIJA and
observational cohorts. Patients with chronic obstructive pulmonary
disease (COPD), asthma, or other chronic respiratory disease within
the last five years were excluded from this study.
About Acorda Therapeutics
Acorda Therapeutics develops therapies to restore function and
improve the lives of people with neurological disorders. INBRIJA is
a prescription medicine used for the return of Parkinson’s symptoms
(known as OFF episodes) in adults treated with carbidopa-levodopa
medicines. 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 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 INBRIJA (levodopa inhalation powder)
INBRIJA is the first and only inhaled levodopa 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 platform for
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 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
- feel dizzy, nausea, sweaty, or faint when standing from
- 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
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
- 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
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.
version on businesswire.com: https://www.businesswire.com/news/home/20190726005267/en/
MEDIA CONTACT Gail Cohen (914) 326-5162
INVESTOR RELATIONS CONTACT Felicia Vonella (914) 326-5146
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