* Detailed RECOVER trial analysis presented at major international congress
Brussels (Belgium), 17th June 2010, 1430 CET - New data presented this week at
the 14th International Congress of Parkinson's Disease and Movement Disorders in
Buenos Aires, Argentina (June 13-17, 2010) showed that Neupro(®) (rotigotine)
provided significantly greater improvement in early morning motor symptoms and
sleep quality, compared with placebo, and as measured by the Unified Parkinson's
Disease Rating Scale and the Parkinson's Disease Sleep Scale. [1],[2]
The latest data come from an analysis from the RECOVER study - 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.
"Sleeping without being restless, uncomfortable or immobile during the night may
be just as important to people with Parkinson's disease, as being able to move
around during the day" said Professor Claudia Trenkwalder from the
Paracelsus-Elena Hospital, Kassel, Germany. "Findings from the RECOVER study
showed that rotigotine was an effective treatment option for patients with
Parkinson's disease having beneficial effects on both motor and non-motor
symptoms."
About the RECOVER trial analysis
Of the 287 patients with idiopathic Parkinson's disease and unsatisfactory early
morning motor control 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. Patients were hospitalized for two
nights before assessment at baseline and again at the end of the maintenance
period.
Early morning motor function was assessed from baseline to the end of
maintenance using the Unified Parkinson's Disease Rating Scale (UPDRS) Part III
(Motor Examination), a comprehensive, widely used evaluation of motor symptoms.
Additional exploratory endpoints were the UPDRS Part II (Activities of Daily
Living) and Part II+III scores, assessed from baseline to end of treatment.
Responder rates were also assessed, with responders defined as people with a) ≥
20% and b) ≥ 30% improvements in UPDRS Part III score from baseline to end of
maintenance.
Sleep quality was assessed using the modified Parkinson's Disease Sleep Scale
(PDSS-2) from baseline to end of maintenance. The PDSS-2 assesses sleep
disturbance, nocturnal motor and non-motor symptoms. Mean changes in PDSS-2
domain and individual item scores were additional exploratory endpoints.
The co-primary efficacy endpoints were the mean change from baseline to end of
maintenance in PDSS-2 and UPDRS Part III scores.
Primary efficacy endpoints [1],[2]
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). Rotigotine also
provided significantly greater improvement than placebo in sleep quality scores
as measured by the PDSS-2 total score (-6.08 vs -2.45 points; treatment
difference -4.26; p<0.0001).( )
Additional exploratory endpoints [1],[2]
()
* Improvement in PDSS-2 score for disturbed sleep was significantly better
with rotigotine than placebo (treatment difference -1.4 points;
p=0.0009),and within this domain, scores were better for difficulty falling
asleep (treatment difference -0.46 points; p=0.0008) and feeling tired and
sleepy in the morning (treatment difference -0.4 points; p=0.0036). No
significant differences were seen for poor sleep quality, difficulty staying
asleep or need to get up and pass urine.
* PDSS-2 scores for motor symptoms at night were significantly better with
rotigotine than placebo (treatment difference -1.54 points; p<0.0001), and
within this domain, scores were better for restlessness of legs or arms
(treatment difference-0.36 points; p=0.0025), urge to move legs or arms
(treatment difference -4.3 points;p=0.0003), painful posturing in the
morning (treatment difference -0.34 points); p=0.0027) and tremor on waking
(treatment difference -0.33 points; p=0.0153). The only item not to show a
significantly greater improvement with rotigotine was distressing dreams.
* Patients had fewer PD symptoms at night with rotigotine than placebo,
according to PDSS-2 domain scores (-1.41 points; p<0.0001), and within this
domain, scores were better for feeling uncomfortable and immobile (-0.49
points; p<0.0001), pain in arms or legs (-0.36; p=0.001), muscle cramps in
arms or legs (-0.31; p=0.0067), and breathing difficulties or snoring
(-0.24; p=0.0064). Only scores for distressing hallucinations showed no
difference between the two groups.
* Patients experienced significantly greater improvements in UPDRS Part II
(Activities of Daily Living) with rotigotine than placebo (-2.6 vs -1.3
points; treatment difference -1.49; p=0.0005), and significantly greater
improvements in Part II+III scores (-9.6 vs -5.2 points; treatment
difference -4.95; p<0.0001).
* UPDRS Part III responder rates were higher with rotigotine than placebo (≥
20% improvement: rotigotine 52%, placebo 33%; ≥ 30% improvement: rotigotine
38%, placebo 19%).
In the RECOVER study, 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%). [3]
For further information
Eimear O Brien, Associate Director, Global CNS Communications
T +32 2 559 9271, eimear.obrien@ucb.com <mailto:eimear.obrien@ucb.com>
Andrea Levin / Public Relations Manager, CNS, UCB, Inc.
Office: 770.970.8352 / Mobile: 404.483.7329 / Email:andrea.levin@ucb.com
<mailto:andrea.levin@ucb.com>
About Neupro(®) in Europe [4]
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(4)()
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) 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.
Recently the U.S. Food and Drug Administration (FDA) has recommended that UCB
reformulate Neupro(®) patches and UCB is working on the development of a new
formulation. Patients and physicians with questions about the status of
Neupro(®), or about UCB's Patient Access program for Neupro(®), may contact UCB
Medical Information at 1-866-822-0068 (option 9).
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 a registered trademark of the UCB Group of companies.
Neupro(®) is not available in Argentina for the treatment of Parkinson's
disease.
References
1. Trenkwalder( )C, Kies( )B, Rudzinska( )M, Fine( )J, Niki J, Hill( )DL,
Anderson( )T, Surmann( )E, Whitesides( )J, Boroojerdi( )B, Chaudhuri( )KR,
on behalf of the RECOVER study group. Effect of rotigotine on control of
early morning motor function in Parkinson's disease. RECOVER study. Poster
session II, June 15(th) 2010, 0900-1800. Presented at the 14th International
Congress of Parkinson's Disease and Movement Disorders, Buenos Aires,
Argentina .
2. Trenkwalder( )C, Kies( )B, Rudzinska( )M, Fine( )J, Niki J, Hill( )DL,
Anderson( )T, Surmann( )E, Whitesides( )J, Boroojerdi( )B, Chaudhuri( )KR,
on behalf of the RECOVER study group. Effect of rotigotine on sleep and
nocturnal symptoms in Parkinson's disease. RECOVER study. Poster session
III, June 16(th) 2010, 0900-1800. Presented at the 14th International
Congress of Parkinson's Disease and Movement Disorders, Buenos Aires,
Argentina .
3. 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).
4. Neupro(®) European Summary of Product Characteristics (Approved March
15(th) 2010)
http://www.emea.europa.eu/humandocs/PDFs/EPAR/neupro/emea-combined-h626en.pd
f
About UCB
UCB, Brussels, Belgium (www.ucb.com <
http://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).
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[HUG#1424719]
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