New data presented at the American Academy of Neurology meeting showed that Neupro® (rotigotine transdermal system) improved both motor and non-motor symptoms of Parkinson's disease
(Thomson Reuters ONE) -
* Analysis of RECOVER - first multinational study in a controlled setting to
address the non-motor symptoms of Parkinson's disease - presented at major
North American neurology congress
* Rotigotine( )provided sustained efficacy and tolerability in long term
studies of early and late stage idiopathic Parkinson's disease
Atlanta (U.S.) - 14 April 2010 - Evidence of Neupro(®) (rotigotine transdermal
system) improving motor as well as non-motor symptoms of Parkinson's disease
were presented at the 62(nd) American Academy of Neurology annual meeting in
Toronto, Canada(1,2).
"The new data reported this week showed that treatment with rotigotine
controlled early morning motor function and improved non-motor symptoms, as
judged by the validated non-motor scale, in patients with Parkinson's disease
and these effects translated into improvements in quality of life for our
patients. RECOVER is the first study carried out in a controlled setting that
addresses the non-motor symptoms of Parkinson's disease, such as sleep, mood,
cognition and pain which can be just as debilitating to patients as the more
obvious movement disorder." said Professor Ray Chaudhuri, Consultant Neurologist
and Professor in Neurology and Movement Disorders at Kings College NHS
Foundation Trust, and Kings Health Partners, London, UK.
These new findings were reported in extensive analyses of data from RECOVER - a
multicentre, multinational, double-blind, placebo-controlled study designed to
assess the effects of rotigotine in controlling early morning motor function and
non-motor symptoms that affect the everyday lives of people with Parkinson's
disease.
Of the 287 Parkinson's patients in RECOVER, 190 were randomized to rotigotine
and 97 to placebo. The dose of rotigotine or placebo was tailored to individual
patient need (2-16mg/24h or placebo) during a titration period lasting up to 8
weeks, followed by a 4 week maintenance period.
Early morning motor function was assessed using the Unified Parkinson's Disease
Rating Scale (UPDRS) Part III (Motor Examination) and sleep quality was assessed
using the Parkinson's Disease Sleep Scale (PDSS). Patients were hospitalized for
two nights before assessment at baseline and again at the end of the maintenance
period. The co-primary efficacy endpoints were the mean change from baseline to
end of maintenance in PDSS and UPDRS Part III scores. Non-motor symptoms were
assessed as secondary outcomes.
Key primary and secondary outcomes from baseline to end of maintenance
were(1,2):
Motor symptoms and primary efficacy endpoints
Rotigotine provided significantly greater improvement in early morning motor
symptoms than placebo (-7.0 vs -3.9 points; treatment difference -3.55;
p=0.0002) as measured by the UPDRS Part III (Motor Examination), a comprehensive
widely used evaluation of motor symptoms as well as cognition, behaviour and
mood. Rotigotine also provided significantly greater improvement than placebo in
sleep quality scores as measured by the PDSS (-5.9 vs -1.9 points; difference
-4.26; p<0.0001).
Non-motor symptoms()
* Overall patients experienced greater improvements in non-motor symptoms with
rotigotine than placebo (-11.4 vs -6.3 points; treatment difference -6.65;
p=0.015), as measured by the Parkinson's disease Non-Motor Symptoms
assessment scale total (NMST), which measures the severity and frequency of
nine categories of non-motor symptoms, including cardiovascular,
sleep/fatigue, mood/cognition and attention/memory
* Rotigotine provided greater improvement than placebo in sleep/fatigue
(treatment difference -2.03; p=0.002) and in mood/cognition (treatment
difference -3.40; p=0.0003) as measured by the NMST
* Rotigotine provided greater improvement than placebo in mood (treatment
difference -2.01; p=0.011) as measured by the Beck Depression Inventory
(BDI-II), a widely used questionnaire developed to measure the intensity,
severity and depth of depression
* Rotigotine provided greater improvement than placebo in quality of life
(treatment difference -5.74, p=0.0002) as measured by PDQ-8, a short form
Parkinson's disease questionnaire
* Rotigotine provided greater improvement than placebo in pain (treatment
difference -0.77, p=0.004) as measured by the Likert scale
* There was no change in the number of nocturias (excessive urination at
night) in either the rotigotine or placebo group
Tolerability
The most frequently reported adverse events were nausea (rotigotine 21%, placebo
9%), application site reactions (rotigotine 15%, placebo 4%), and dizziness
(rotigotine 10%, placebo 6%).
Tolerability and efficacy of rotigotine( )up to 6 years demonstrated in early
stage Parkinson's disease
Rotigotine( )was generally well tolerated and provided sustained improvement in
movement symptoms in patients with early Parkinson's disease treated for up to
6 years, according to new data from an open label extension of an earlier double
blind trial, also presented at the congress(3).
Of 216 patients who received treatment during the open label phase more than
half (52%) received at least five years of rotigotine treatment. Overall, 24% of
patients discontinued due to adverse events, of which the most frequently
reported (rate per patient year) were somnolence (23% per patient-year),
peripheral edema (14% per patient-year), and fall (17% per patient-year).
Treatment-emergent application site reactions were reported in 70 (32%) of
patients during open label treatment (12% per patient-year). Mean UPDRS (II +
III) scores after up to 6 years of rotigotine treatment remained within 4 points
of patients' original double-blind baseline scores.
Long term efficacy and tolerability of rotigotine( )in advanced Parkinson's
disease
Continued efficacy and tolerability were also reported in long term follow up
studies of over 600 patients who enrolled in open label extensions of two
previous double blind trials of rotigotine( )in advanced Parkinson's disease(4).
A four year open label extension trial enrolled 395 patients. While UPDRS
Activities of Daily Living (ADL) mean total score improved from double-blind
baseline by -4.5 points during the open label titration to rotigotine
4-16mg/24h, it gradually returned to baseline values (+0.8 points) over 4 years.
The mean UPDRS Motor Score (MS) improved from double-blind baseline by -10.1
points during titration then gradually declined to -2.8 points of improvement.
Of 258 patients who entered the open label phase of a second study, 68 (26%)
withdrew by the end of year 6 because of adverse events. The -4.9-point mean ADL
score improvement achieved during titration declined to +4.1 points above
baseline over 6 years, and the mean MS declined from an initial -11.4-point
improvement to baseline values (-0.2 points). Treatment-emergent adverse effects
were typically dose-related dopaminergic effects (such as insomnia, (5-7% per
patient-year), dyskinesias (4-8% per patient-year), and hallucinations (4-8% per
patient-year).
For further information
Onsite at meeting
Andrea Levin / Public Relations Manager, CNS, UCB, Inc.
Office: 770.970.8352 / Mobile: 404.483.7329 / Email:andrea.levin(at)ucb.com
Eimear O Brien, Associate Director, Global CNS Communications
T +32 2 559 9271,eimear.obrien(at)ucb.com
Antje Witte, Investor Relations UCB
T +32.2.559.9414,antje.witte(at)ucb.com
About Neupro(®) in Europe(5
)Neupro(®) (rotigotine) is approved in the European Union for the treatment of
the signs and symptoms of early-stage idiopathic Parkinson's disease, as
monotherapy (i.e. without levodopa) or in combination with levodopa, i.e. over
the course of the disease, through to late stages when the effect of levodopa
wears off or becomes inconsistent and fluctuations of the therapeutic effect
occurs. Neupro(®) is also approved in the European Union for the symptomatic
treatment of moderate to severe idiopathic restless legs syndrome in adults.
Neupro(®) in Europe Important Safety Information(5
)Neupro(®) is contraindicated in case of hypersensitivity to the active
substance or to any of its excipients, and in case of magnetic resonance imaging
(MRI) or cardioversion. Neupro(®) should be removed if the patient has to
undergo MRI or cardioversion.
It is recommended to monitor blood pressure, especially at the beginning of
treatment, due to the general risk of orthostatic hypotension associated with
dopaminergic therapy.
Neupro(®) has been associated with somnolence episodes of sudden sleep onset
episodes. Patients treated with dopamine agonists including Neupro(®), have been
reported as exhibiting signs of pathological gambling, increased libido and
hypersexuality.
Symptoms suggestive of neuroleptic malignant syndrome have been reported with
abrupt withdrawal of dopaminergic therapy. Therefore it is recommended to taper
treatment.
Neupro(®) contains sodium metabisulphite, a sulphite that may cause
allergic-type reactions including anaphylactic symptoms and life threatening or
less severe asthmatic episodes in certain susceptible people.
Hallucinations have been reported, and patients should be informed that
hallucinations can occur.
Cases of cardiopulmonary fibrotic complications have been reported in some
patients treated with ergot-derived dopaminergic agents. Neuroleptics given as
antiemetic should not be given to patients taking dopamine agonists.
Ophthalmologic monitoring is recommended at regular intervals or if vision
abnormalities occur.
External heat, from any source should not be applied to the area of the patch.
Exposure of a skin rash or irritation to direct sunlight could lead to changes
in the skin color. If a generalized skin reaction (e.g. allergic rash)
associated with the use of Neupro(®) is observed, Neupro(®) should be
discontinued.
Caution is advised when treating patients with severe hepatic impairment or
acute worsening of renal function, a dose reduction might be needed.
The incidence of some dopaminergic adverse events, such as hallucinations,
dyskinesia, and peripheral oedema generally is higher when given in combination
with L-dopa. This should be considered when prescribing Neupro(®).
Neupro(® )should not be used during pregnancy. Breast-feeding should be
discontinued.
Augmentation may occur in Restless Legs Syndrome patients. Augmentation refers
to the earlier onset of symptoms in the evening (or early afternoon), increase
in severity of symptoms, and spread of symptoms to involve other body parts.
Adverse drug reactions reported in more than 10% of Parkinson's patients treated
with Neupro(®) are nausea, vomiting, application site reactions, somnolence,
dizziness and headache.
Adverse drug reactions reported in more than 10% of RLS patients treated with
Neupro(®) are nausea, application site reactions, asthenic conditions and
headache.
All Neupro(®) supply should be stored in a refrigerator. There is no need for
patients to transport Neupro(®) patches in special containers and they must not
be stored in a freezer compartment.
Please refer to the European Summary of Product Characteristics for full
prescribing information (Approved 15(th) March 2010):
http://www.emea.europa.eu/humandocs/PDFs/EPAR/neupro/emea-combined-h626en.pdf
About Neupro(®) in the U.S.
Neupro(® )(Rotigotine Transdermal System) is indicated in the U.S. for the
treatment of the signs and symptoms of early-stage idiopathic Parkinson's
disease.
In April 2008, UCB recalled Neupro(®) from the U.S. market after ongoing
monitoring revealed that specific batches of Neupro(®) had deviated from their
approved specification. Neupro(®) is currently not available in the U.S. UCB is
working with the U.S. FDA so that Neupro(®) can be available to patients with
early-stage Parkinson's disease as soon as possible.
Important Safety Information - U.S.
Some patients treated with Neupro(®) reported falling asleep while engaged in
activities of daily living, including operation of motor vehicles, which
sometimes resulted in accidents. Some patients perceived no warning signs, such
as excessive drowsiness. Hallucinations were reported in 2.0% of patients
treated with Neupro(®) compared to 0.7% of patients on placebo. Neupro(®)
contains metabisulfite. Neupro(®) should be used with caution in patients,
especially those at risk for cardiovascular disease, because of the potential
for symptomatic hypotension, syncope, elevated heart rate, elevated blood
pressure, fluid retention, and/or weight gain. All Parkinson's disease patients
are at a higher risk for melanoma and should be monitored regularly. The most
commonly reported side effects in clinical trials were nausea, application site
reactions, somnolence, dizziness, headache, vomiting, and insomnia. Some
subjects who received Neupro(®) experienced a decline in blood hemoglobin levels
(about 2% relative to subjects who received placebo). It is not known whether
this change is readily reversible with discontinuation of Neupro(®).
Neupro(®) is not approved or available in Canada for the treatment of idiopathic
Parkinson's disease or for the treatment of Restless Legs Syndrome
Neupro(®) is a registered trademark of the UCB Group of companies.
References
1. Chaudhuri( )KR, Rudzinska( )M, Kies( )B, Fine( )J, Hill( )DL, Anderson(
)T, Surmann( )E, Whitesides( )J, Boroojerdi( )B, Trenkwalder( )C, on behalf of
the RECOVER study group. Effect of rotigotine on non-motor symptoms in subjects
with idiopathic Parkinson's disease. Presented at the 62(nd) American Academy of
Neurology annual meeting, Toronto, Canada (April 10-17 2010)
2. Kies( )B, Chaudhuri( )KR, Anderson( )T, Fine( )J, Hill( )DL, Rudzinska
M, Surmann( )E, Whitesides( )J, Boroojerdi( )B, Trenkwalder( )C, on behalf of
the RECOVER study group. Effect of rotigotine on sleep quality and control of
early morning motor function in subjects with idiopathic Parkinson's disease.
Presented at the 62(nd) American Academy of Neurology annual meeting, Toronto,
Canada (April 10-17 2010)
3. Watts( )RL, Boroojerdi( )B, Jankovic( )J. Open-label extension to the
double-blind SP512 trial to assess the safety of long-term treatment of
rotigotine in subjects with early-stage idiopathic Parkinson's disease.
Presented at the 62(nd) American Academy of Neurology annual meeting, Toronto,
Canada (April 10-17 2010)
4. LeWitt( )PA, Boroojerdi( )B, Poewe( )W. ( )Long-term treatment of
advanced Parkinson's disease with rotigotine. Presented at the 62(nd) American
Academy of Neurology annual meeting, Toronto, Canada (April 10-17 2010)
5. Neupro(®) European Summary of Product Characteristics (Approved March
15(th) 2010)
http://www.emea.europa.eu/humandocs/PDFs/EPAR/neupro/emea-combined-h626en.pdf
About UCB
UCB, Brussels, Belgium (www.ucb.com) is a biopharmaceutical company dedicated to
the research, development and commercialization of innovative medicines with a
focus on the fields of central nervous system and immunology disorders.
Employing more than 9 000 people in over 40 countries, UCB produced revenue of
EUR 3.1 billion in 2009. UCB is listed on Euronext Brussels (symbol: UCB).
Forward looking statement
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estimates and beliefs of management. Such statements are subject to risks and
uncertainties that may cause actual results to be materially different from
those that may be implied by such forward-looking statements contained in this
press release. Important factors that could result in such differences include:
changes in general economic, business and competitive conditions, effects of
future judicial decisions, changes in regulation, exchange rate fluctuations and
hiring and retention of its employees.
For the pdf-version of this press release, please click on the link below:
[HUG#1403319]
Press release (PDF): http://hugin.info/133973/R/1403319/357616.pdf
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