Continuing Clinical Development Improvement in Treatment of Parkinson's/SCHWARZ PHARMA Is Running Phase III Clinical Trials For Rotigotine CDS
17.04.2002, 08:23
Denver, Colorado 17.04.2002 (PROTEXT/ots) - Today, 16th April2002, at the 54th annual meeting of the American Academy ofNeurology (AAN) in Denver, USA, results from a study of patientswith early Parkinson's Disease, administered rotigotine CDS -the Parkinson's Patch - were presented. Rotigotine CDS deliversa novel selective non-ergolinic dopamine agonist transdermallyover 24 hours. The Parkinson's Patch was developed by SCHWARZPHARMA to test the hypothesis that delivery of the dopamineagonist in a non-pulsatile way is beneficial in patients withearly and advanced Parkinson's Disease patients.
This parallel dose study of 316 patients in a multi-centerrandomized placebo controlled trial showed a dose dependentimprovement in the Unified Parkinson's Disease Rating Scale(UPDRS) Parts II and III (defined as an improvement in patientsymptoms including the ability to undertake activities associatedwith daily life). The study showed that rotigotine CDSsignificantly improved patients' motor function and was welltolerated in early Parkinson's Disease patients.
SCHWARZ PHARMA has now initiated Phase III clinical trialsfor this novel selective non-ergolinic dopamine (DA) agonisttreatment. This development comes at a time when the latest 2001AAN guidelines support the use of dopamine agonists as a firstline treatment in early Parkinson's Disease. In addition,scientific evidence suggest that continuous stimulation of DAreceptors is preferable to pulsatile stimulation.
Phase III multi-center, randomized placebo controlledclinical trials with rotigotine CDS for the treatment of theearly and advanced stages of Parkinson's Disease in almost 1,000patients were initiated in November 2001.
The unique rotigotine Constant Delivery System (CDS) is aninnovative approach which combines the advantages of a non-ergoline, dopamine agonist on D3 /D2 receptors with transdermaldelivery over 24 hours. The Parkinson's Patch is applied once aday to the skin and is replaced by a new patch after 24 hours,therefore potentially improving patient compliance. Unlike oralmedications, rotigotine CDS has the potential to deliver thedopamine agonist in a non- pulsatile way which may be beneficialin treating Parkinson's Disease patients.
Parkinson's Disease currently affects at least 4 millionpeople throughout the world, with a prevalence of approximately20 in 100,000 people, rising dramatically to 120 per 100,000people in patients aged 70 plus per year. This progressiveneurological disease results in motor function impairment leadingto a range of symptoms from tremor and postural instability tospeech disorder, dementia and loss of bladder and sphinctercontrol. In today's aging society the improved long termmanagement of Parkinson's Disease is vital.
SCHWARZ PHARMA AG (headquartered in Monheim, Germany)develops and markets innovative drugs for unmet medical needswith focus on CNS, urology and cardiovascular diseases. Thecompany is investing in development projects targeting diseasessuch as Parkinson's, epilepsy, neuropathic pain andincontinence. The company has a strong international presencewith subsidiaries in Europe, USA and Asia. Shares of SCHWARZPHARMA AG are traded on the Frankfurt and Duesseldorf stockexchanges. (www.schwarzpharma.com, e-mail:info@schwarzpharma.com, phone: +49(0)2173/48- 1866)
For further information please contact:- Julie Dean or LesleyScott at hsdcommunications, Gable House, 40 High Street,Rickmansworth, Herts, UK, WD3 1ER. Telephone: + 44 1923 777277Fax: +44 1923 777275 email: jdean@hsdcommunications.comlscott@hsdcommunications.com
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