AAN Data Show UCB's Neupro Effective and Safe in Late- and Early-stage Parkinson's and RLS

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, 2010 – Extensive new data on rotigotine will be presented at the 62nd American Academy of Neurology annual meeting in Toronto, Canada between April 10th and 17th, 2010.

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).

Oral presentations

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 Högl 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 cognition.
Date: Wednesday, April 14, 2010
Scientific Session #: S23.006: Movement Disorders: Parkinson's Disease/Non-Motor
Authors present: 3:15 PM EDT
Place: Room 718AB
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 group

The presentation will report on the long-term efficacy and tolerability of rotigotine in early stage Parkinson’s disease.
Date: Wednesday, April 14, 2010
Poster #: P04.133: Movement Disorders: Parkinson’s Disease: Treatment
Authors present: 6:00 PM EDT
Place: Room 808
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.

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 as possible.

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 employees.

 

 


Iris D. Shaffer Cooney/Waters Group on behalf of UCB phone: 708.799.6284 mobile: 708.297.1712 ishaffer@cooneywaters.com

 

 

Posted: April 2010

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