Schwarz Pharma's Neupro (rotigotine Transdermal Patch) Offers Additional Benefits For Parkinson's Disease

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Main Category: Parkinson's Disease
Article Date: 06 Sep 2006 - 8:00 PDT

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At the 10th Congress of the European Federation of Neurological Societies (EFNS) Schwarz Pharma presented new data on Neupro from clinical trials for patients with early and advanced stage Parkinson's disease, the results indicated that:

-- Patients switched easily overnight to Neupro from other oral dopamine agonist treatments

-- Neupro can improve quality of sleep

-- Patients showed continuous improvement in long-term treatment

Neupro, with the active ingredient rotigotine, is a dopamine receptor-agonist delivered via a transdermal delivery system i.e. a patch. The patch is applied once a day to the skin and releases rotigotine continuously through the skin into the body over 24 hours. This delivery method helps maintain a stable rotigotine plasma concentration level over 24 hours. Most currently available oral dopamine agonists are multiple dose - i.e. patients need to take pills several times a day.

In February 2006, Neupro was approved for the treatment of early stage Parkinson's disease by the European Commission. The Parkinson's patch has been launched in Europe: in Germany, the UK and Austria with additional European countries to follow.

An overview of Neupro clinical studies at the EFNS

Early stage Parkinson's disease clinical trials

Open-label clinical trial results presented at the EFNS showed that patients treated with a dopamine agonist (e.g. ropinirole, pramipexole) were able to easily switch overnight to an effective regimen of rotigotine transdermal patch.

A report from two open-label trials showed that transdermal rotigotine improved sleep quality in Parkinson's disease patients to a clinically significant extent. In particular, a decrease in the number of sleep-related motor disturbances and a reduction in the frequency of nocturia were observed.

Long-term experience with rotigotine transdermal patch was also presented and discussed at the EFNS. More than 200 patients with early stage Parkinson's disease were observed in an open-label follow-up over a period of 85 weeks after a 24 week double-blind treatment. The interim results indicate that rotigotine treated patients experienced the same side effects seen in other trials with rotigotine and a continued improvement in symptoms.

Advanced stage Parkinson's disease clinical trials

In a phase III trial, also presented at the EFNS, which was conducted in Europe and other regions, 506 patients with advanced stage idiopathic Parkinson's disease were randomized. This double-blind, placebo- and active-comparator (pramipexole) controlled trial had an up to 7-week titration phase and a 16-week maintenance phase. Rotigotine transdermal patch was added to stable levodopa treatment. The primary parameters were the change from baseline in the absolute 'off' time and the response rate. Response was defined as a decrease in absolute 'off' time from baseline by at least 30%. Also, non-inferiority to pramipexole was shown and a favorable increase in 'on' time without troublesome dyskinesia was observed.

The variation application for rotigotine transdermal patch for the treatment of patients with advanced stage Parkinson's disease was submitted to the European Medicines Agency (EMEA) in the second quarter 2006.

The most common adverse events associated with the use of rotigotine transdermal system were application site reactions (consistent with the use of a transdermal delivery system) as well as nausea, headache, somnolence and vomiting.

About Parkinson's disease:

Parkinson's disease is a disorder of the central nervous system. The patients - roughly four million worldwide - suffer from a lack of dopamine, a messenger substance in the central nervous system, which is responsible for the coordination of movement. As a result of this shortage, patients are no longer able to control their movements reliably. Dopamine agonists attempt to compensate for this lack of dopamine.

About Schwarz Pharma:

Schwarz Pharma (headquartered in Monheim, Germany) is a stock listed company with approximately 4,200 employees worldwide. The company develops novel medicines in the therapeutic areas of the central nervous system. Furthermore it markets innovative drugs focused to treat cardiovascular and gastro-intestinal diseases. In 2005 the SCHWARZ PHARMA group achieved global sales of nearly 1 billion. The company has a strong international presence with subsidiaries in Europe, USA and Asia.

www.schwarzpharma.com


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