Extensive Neupro (Rotigotine Transdermal System) Data to be Presented at the 62nd American Academy of Neurology Meeting in Toronto, Canada
New data from RECOVER study on effects of rotigotine on both motor and non-motor symptoms of Parkinson's disease - New 5-year safety and efficacy data on rotigotine in Restless Legs Syndrome
ATLANTA, April 8 /PRNewswire/ -- Extensive new data on
rotigotine will be presented at the 62nd American Academy of
Neurology annual meeting in Toronto, Canada between April 10th and
At a series of oral and poster presentations, leading
international investigators will report the latest data on
rotigotine in all stages of Parkinson's disease and in moderate to
severe Restless Legs Syndrome (RLS).
SP710 (5 year) Long-term Safety and Efficacy of Rotigotine in
Patients with Idiopathic RLS: 5-year Results from a Prospective
Multinational Open-label Follow-up Study
Hogl B, Trenkwalder C, Garcia-Borreguero D, Kohnen R, Poewe W,
Stiasny-Kolster K, Bauer L, Fichtner A, Schollmayer E, Oertel W for
the SP710 study group
The presentation will report on the final 5-year analysis from a
prospective follow-up of a placebo-controlled phase II trial with
rotigotine in patients with moderate to severe RLS.
Date: Tuesday, April 13, 2010 Scientific Session #: S04.006: Sleep Disorders Authors present: 3:00 PM EDT Place: Constitution Hall 107
RECOVER: Effect of Rotigotine on Non-motor Symptoms in Subjects
with Idiopathic Parkinson's Disease
Chaudhuri KR, Rudzinska M, Kies B, Fine J, Hill DL, Anderson T,
Surmann E, Whitesides J, Boroojerdi B and Trenkwalder C, on behalf
of the RECOVER study group
The presentation will report on the effect of rotigotine on
non-motor symptoms of Parkinson's disease, such as sleep, mood and
Date: Wednesday, April 14, 2010 S23.006: Movement Disorders: Parkinson's Disease/ Scientific Session #: Non-Motor Authors present: 3:15 PM EDT Place: Room 718AB Poster presentations
RECOVER: Effect of Rotigotine on Sleep Quality and Control of
Early Morning Motor Function in Subjects with Idiopathic
The presentation will report on the effects of rotigotine on
movement and sleep problems in people with Parkinson's
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
Date: Tuesday, April 13, 2010 P01.240: Movement Disorders: Parkinson's Disease/ Poster #: Non-Motor Symptoms Authors present: 7:30 AM EDT Place: Room 808 Long-Term Treatment of Advanced Parkinson's Disease With Rotigotine
LeWitt P, Boroojerdi B, Poewe W, on behalf of the SP516 and
SP715 study groups
The presentation will report on the long-term efficacy (over 4-6
years) of rotigotine in people with advanced Parkinson's
Date: Wednesday, April 14, 2010 P04.131: Movement Disorders: Parkinson's Disease: Poster #: Treatment Authors present: 6:00 PM EDT Place: Room 808
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
Watts R, Boroojerdi B, Jankovic J, on behalf of the SP702 study
The presentation will report on the long-term efficacy and
tolerability of rotigotine in early stage Parkinson's
Date: Wednesday, April 14, 2010 P04.133: Movement Disorders: Parkinson's Disease: Poster #: Treatment Authors present: 6:00 PM EDT Place: Room 808 For further information Andrea Levin / Public Relations Manager, CNS, UCB, Inc. Office: 770.970.8352 /Mobile: 404.483.7329 /Email: firstname.lastname@example.org Will be available on site at the meeting 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
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
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
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
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
Please refer to the European Summary of Product Characteristics
for full prescribing information (Approved 15th March 2010):
About Neupro® in the U.S.
In May 2007 Neupro® (rotigotine transdermal system) was
approved by the U.S. Food and Drug Administration (FDA) 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
Neupro® is a registered trademark of the UCB Group of companies. About UCB
UCB, Brussels, Belgium 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
CONTACT: Andrea Levin, Public Relations Manager, CNS, UCB,
+1-770-970-8352, mobile +1-404-483-7329, email@example.com
Web Site: http://www.ucb.com/
Posted: April 2010