Rotigotine Study To Investigate 24-hour Action And Sleep Benefits In Parkinson's Patients

Main Category: Parkinson's Disease
Also Included In: Sleep / Sleep Disorders / Insomnia
Article Date: 14 Apr 2007 - 15:00 PDT

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Symptoms occurring early in the morning or during the night are problems that are common in Parkinson's disease but are often inadequately treated or understood. SCHWARZ PHARMA will address this problem in a new large-scale international study RECOVER.

In the development program performed to date results indicate that Neupro® (rotigotine transdermal patch) with its 24-hour drug release may improve sleep problems and early morning motor symptoms in Parkinson's patients. These data are now to be corroborated in a double-blind, placebo-controlled study.

Parkinson's disease is often regarded as just a motor disease although increasingly it is being recognised that patients also suffer from a number of non-motor symptoms. Among these symptoms are sleep related disturbances such as difficulty getting to sleep and reduced quantity of sleep which can have a significant impact on a patient's quality of life.

The frequency and severity of non-motor symptoms has so far been greatly underestimated. Dr. Ray Chaudhuri, a Parkinson's expert from the King's College and University Hospital Lewisham in London, estimates that between 50 and 60 % of Parkinson's patients are affected by sleep problems.

Patients may also experience motor problems early in the morning which can have an impact on their ability to start their daily activities.

Treating these symptoms with conventional, oral therapies may be difficult since oral therapies require dosing multiple times a day. Neupro®, approved in Europe for the treatment of idiopathic Parkinson's disease, offers a therapeutic option that delivers the active substance over a 24-hour period - thus covering the whole of the day and night with a once-daily application.

Neupro® with its active substance rotigotine is a non-ergoline dopamine agonist formulated as a transdermal patch. The first transdermal patch to treat

Parkinson's disease is available in many European markets, including Germany, United Kingdom, Republic of Ireland, Austria, Spain, Switzerland, Greece, Poland and the Scandinavian countries. Further market introductions are planned.

The drug is approved both as monotherapy for patients with early-stage Parkinson's disease and in combination with levodopa for the treatment of patients with advanced-stage Parkinson's disease.

Studies performed to date indicate that Neupro may be effective at night and in the early morning. "We have conducted rotigotine trials, and the results are very impressive,"said Dr. Chaudhuri.

These results are now to be corroborated in RECOVER (Randomized Evaluation of the 24-hour-COVerage: Efficacy of Rotigotine), a placebocontrolled, double-blind, multi-centre, multinational study. This is the first time that "Sleep and early morning symptoms in Parkinson's patients" have been investigated in a large-scale study. It is also the first time that other, non-motor Parkinson's symptoms are being examined by using a new state-of-the-art diagnostic instrument assessing the full range of non-motor symptoms. The study, which is scheduled to start in April, will enrol more than 330 patients at a ratio of two to one to the rotigotine and the placebo arm, respectively. The principal investigator, Professor Claudia Trenkwalder from the University of Göttingen and Paracelsus-Elena Hospital, Kassel, says that the RECOVER study will include centres in the USA, Europe and Australia.

Parkinson's disease is a functional disorder of the central nervous system. The four million patients worldwide suffer from a deficiency of dopamine, a transmitter in the central nervous system that controls the coordination of movements. Because of this deficiency, the patients are unable to reliably control their flow of movement. Dopamine agonists are used to compensate for the dopamine deficiency.

SCHWARZ PHARMA (headquartered in Monheim, Germany) is a research driven pharmaceutical company with approximately 4,400 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.

This press release contains forward-looking statements based on current plans, estimates and beliefs of the management of SCHWARZ PHARMA AG. 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 affecting SCHWARZ PHARMA AG, exchange rate fluctuations and hiring and retention of its employees.

www.schwarzpharma.com

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