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SPAN℠-PD, the efficacy and safety study of INBRIJA (CVT-301),
showed significant improvement in motor function during OFF periods in
people with Parkinson’s on a carbidopa/levodopa regimen
INBRIJA was approved in the U.S. in Dec. 2018 and is expected to be
available by prescription in Q1 2019
Acorda Therapeutics, Inc. (Nasdaq:ACOR) today announced that The
Lancet Neurology published results from SPAN℠-PD, the Phase 3
pivotal efficacy trial of INBRIJA™ (levodopa inhalation powder), also
referred to as CVT-301. In the study, INBRIJA 84 mg significantly
improved motor function at 30 minutes during OFF periods in people with
Parkinson’s taking carbidopa/levodopa, the study’s primary endpoint.
Onset of action was seen as early as 10 minutes and the reduction at 30
minutes was maintained at 60 minutes. Multiple secondary endpoints were
supportive of the primary endpoint. Data from the study were first
presented at the 2017 International Congress of Parkinson’s Disease
and Movement Disorders (MDS).
“A well-tolerated, effective treatment for OFF periods between doses of
scheduled medications can help fulfill one of the most important unmet
needs for people with Parkinson’s,” said lead author of the publication
Peter LeWitt, M.D., Director of the Parkinson’s Disease and Movement
Disorders Program at Henry Ford Hospital and professor of neurology at
Wayne State University School of Medicine. “The data published in The
Lancet Neurology support INBRIJA as such a treatment option,
delivering levodopa, the current ‘gold standard’ of Parkinson’s
treatment, in a novel, inhaled form.”
“We’re gratified to see the SPAN-PD trial paper published in one of the
most highly regarded neurology journals, The Lancet Neurology.
We believe this reflects both the quality of the study and the
importance of its clinical results to people with Parkinson’s,” said Ron
Cohen, M.D., Acorda’s President and CEO. “INBRIJA was recently approved
by the FDA, and we are eager to make it available to the Parkinson’s
community during the first quarter of 2019.”
About SPAN℠-PD (NCT02240030)
and Key Results
The Phase 3 pivotal efficacy trial for INBRIJA – SPAN-PD – was a
12-week, randomized, placebo controlled, double blind study evaluating
the effectiveness of INBRIJA versus placebo in patients with Parkinson’s
experiencing OFF periods.
The 339 patients in the trial had mild to moderate Parkinson’s and were
on an oral levodopa plus a dopa-decarboxylase inhibitor (e.g.,
carbidopa). Most were on additional scheduled Parkinson’s medication and
were experiencing at least two hours per day of OFF time. Patients with
asthma, COPD, or other chronic lung disease within the previous five
years were excluded. Patients were randomized into three treatment
groups: 113 in the INBRIJA 60 mg group, 114 in the INBRIJA 84 mg group
and 112 with placebo.
The primary endpoint was the change in the Unified Parkinson’s Disease
Rating Scale (UPDRS) motor scores from pre-dose to 30 minutes post-dose,
evaluated at week 12 during an in-clinic OFF period. INBRIJA 84 mg
showed statistically significant improvement in motor function compared
to placebo as measured by mean change in the UPDRS motor score at 30
minutes post-dose (-9.83 vs. -5.91; p=0.0088).
Key secondary endpoints for INBRIJA versus placebo also were evaluated
at week 12 using a pre-specified hierarchy. The order of hierarchy was
set based on probability of success, guided by a Phase 2 study. The
primary endpoint (INBRIJA 84 mg vs. placebo) was tested first for
statistical significance. Upon achieving significance, the secondary
endpoints were tested for INBRIJA 84 mg vs. placebo as long as each
preceding endpoint reached a significance level of p<0.05. The
hierarchical sequence did not reach statistical significance at Step 3.
Unadjusted (nominal) p-values are presented below for all key secondary
84 mg vs. placebo
Change in UPDRS motor score at 30 min, LS mean (primary)
% OFF to ON and remaining ON at 60 min, Odds ratio
Change in UPDRS motor score at 20 min, LS mean
% subjects improved on Patient Global Impression of Change, Odds
Change in UPDRS motor score at 10 min, LS mean
Change in Parkinson’s disease diary off-state time, LS mean
** Statistically significant on a nominal and adjusted basis
* Nominal p-value; not eligible for statistical significance.
Reported adverse events in at least 4% of patients in the INBRIJA 84 mg
group vs. placebo were: cough (15% vs. 2%), upper respiratory tract
infection (6% vs. 3%), nausea (5% vs. 3%), discolored sputum (5% vs. 0%)
and dyskinesia (4% vs. 0%). Most adverse events of cough in the INBRIJA
treatment groups started within the first 30 days of treatment, and
these were generally assessed as mild or moderate in intensity. Two
patients in the INBRIJA 84 mg group withdrew from the study due to cough.
About INBRIJA™ (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 was formally validated in May 2018.
Important Safety Information
INBRIJA is not to be used if patients take or have taken a nonselective
monoamine oxidase inhibitor such as phenelzine or tranylcypromine within
the last 2 weeks.
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:
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 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)
which 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.
About Parkinson’s and OFF periods
Parkinson’s is a progressive neurodegenerative disorder resulting from
the gradual loss of certain neurons. 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 ARCUS® Technology Platform
The ARCUS Technology Platform allows systemic delivery of medication
through inhalation, by transforming molecules into a light, porous dry
powder. This allows delivery of substantially higher doses of medication
than can be delivered via conventional dry powder technologies. ARCUS
has the potential to be used in the development of a variety of inhaled
medicines. Acorda acquired the ARCUS technology platform as part of the
acquisition of Civitas Therapeutics in 2014.
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 patients with Parkinson’s treated with carbidopa/levodopa.
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.
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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