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BY OUR PHARMA CORRESPONDENT
20 September,2005: Schwarz Pharma will present clinical data on a new transdermal system for the treatment of patients with advanced-stage Parkinson’s disease at the 9th European Federation of Neurological Societies (EFNS) congress September in Athens, Greece.
The company, for the first time, will share a broad spectrum of clinical and pre-clinical data, most importantly, the results of a phase III trial conducted in the U.S. with
rotigotine transdermal system, a Schwarz release said.
In this trial with rotigotine, as adjunctive therapy, there was a statistically significant and clinically relevant reduction in ‘off’ time as well as an increase in ‘on’ time without troublesome dyskinesia. 99% of Parkinson's disease patients who completed the trial continued on rotigotine in an open-label extension trial.
In this double-blind, multicenter U.S. phase III trial, 351 Parkinson's Disease patients with advanced stage idiopathic Parkinson’s disease were randomized. A five-week titration phase was followed by a 24-week maintenance phase. Rotigotine transdermal system was added to stable levodopa treatment. The primary efficacy variable was change from baseline in the absolute `off´ time.
As compared to baseline, ‘off’ time was on average reduced by 2.1 hours and by 2.7 hours in the rotigotine 60 cm2 (27mg/day) and 40cm2 (18mg/day) groups, respectively, compared to a 0.9 hour decrease in the placebo group. The differences between both rotigotine dose arms and placebo were significant with p-values of 0.003 and <0.0001, respectively. The most common adverse events with rotigotine were application site reactions, somnolence, nausea, and dizziness.
The results from a European double-blind, placebo and active comparator controlled phase III trial with rotigotine as
adjunctive therapy in patients with advanced stage Parkinson's disease are expected in the fourth quarter 2005.
The application rotigotine transdermal system for the treatment of Parkinson's disease as monotherapy has been submitted to the EMEA in Europe and the FDA in the US.
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, parkinson's Disease patients are no longer able to control their movements reliably. Dopamine agonists attempt to compensate for this lack of dopamine.
At the EFNS, Schwarz Pharma will present a number of scientific poster presentations and abstracts on clinical and pre-clinical results of rotigotine to treat Parkinson’s disease and restless legs syndrome as well as of lacosamide in epilepsy.
Schwarz Pharma AG is headquartered in Monheim, Germany. The company develops and markets drugs for neurology, urology and cardiovascular diseases. The company is investing in development projects targeting diseases such as Parkinson's disease, restless legs syndrome, epilepsy, neuropathic pain and overactive bladder syndrome. The company has in Europe, USA and Asia. Shares of Schwarz Pharma AG are traded on the Frankfurt and Duesseldorf stock exchanges.
BY OUR PHARMA CORRESPONDENT |
