- 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 endpoints.
Endpoint Hierarchy Order
∆ P-Value 84 mg vs. placebo
Change in UPDRS motor
score at 30 min, LS mean (primary) 1
-3.92
0.0088** % OFF to ON and remaining ON at 60 min, Odds ratio
2 2.65
0.003** Change in UPDRS motor
score at 20 min, LS mean 3
-2.55 0.062
% subjects improved on Patient Global Impression of Change, Odds
ratio 4 2.94
<0.001* Change in
UPDRS motor score at 10 min, LS mean 5
-2.26
0.046* Change in Parkinson’s disease diary off-state time,
LS mean 6 -0.01
0.975 ** 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 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 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 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.
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.
Forward-Looking Statement
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/20190117005694/en/
MEDIA:Gail Cohen(914) 326-5162gcohen@acorda.com
INVESTOR RELATIONS:Felicia Vonella(914)
326-5146fvonella@acorda.com
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