Neupro (rotigotine transdermal system) Showed Significant Benefit on Early Morning Motor Control, Sleep and Nocturnal Symptoms in Patients With Parkinson's Disease
- Detailed RECOVER trial analysis presented at major international congress
BRUSSELS, June 17 /PRNewswire-FirstCall/ -- 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 transdermal system)
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.
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)
greater than or equal to 20% and b) greater than or equal to 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
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
-- 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 (greater than or equal to 20% improvement: rotigotine 52%,
placebo 33%; greater than or equal to 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%).
Abstract: Effect of rotigotine on control of early morning motor
function in Parkinson's Disease: RECOVER study
Trenkwalder C, Kies B, Rudzinska M, Fine J, Nikl J, Hill DL,
Anderson T, Surmann E, Whitesides J, Boroojerdi B, and Chaudhuri KR
on behalf of the RECOVER study group
Poster Session II, June 15th 2010, 0900-1800
Abstract: Effect of rotigotine on sleep and nocturnal symptoms
in Parkinson's Disease: RECOVER study
Trenkwalder C, Kies B, Rudzinska M, Fine J, Nikl J, Hill DL,
Anderson T, Surmann E, Whitesides J, Boroojerdi B, and Chaudhuri KR
on behalf of the RECOVER study group
Poster Session III, June 16th 2010, 0900-1800 For further information Eimear O Brien, Associate Director, Global CNS Communications T +32 2 559 9271, 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 About Neupro® in Europe
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
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 15th 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.
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
This press release contains forward-looking statements based on
current plans, 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.
Source: UCB
CONTACT: Eimear O Brien, Associate Director, Global CNS
Communications,
+32-2-559-9271, eimear.obrien@ucb.com, or Andrea
Levin / Public Relations
Manager, CNS, UCB, Inc., Office: +1-770-970-8352, or Mobile:
+1-404-483-7329,
andrea.levin@ucb.com
Web Site: http://www.ucb.com/
Posted: June 2010
