The response of patients with advanced stage of Parkinson's disease treated with the rotigotine transdermal system as adjunctive therapy showed statistically significant and clinically relevant reduction in 'off' time when compared to placebo treated patients.
Results of the study conducted by Schwarz Pharma showed that both primary endpoints for the US and Europe were achieved and the product appeared to be well tolerated. Also a favourable increase in 'on' time without troublesome dyskinesia was observed. Over 90% of patients who completed the trial continued in an open-label extension trial, claims a company release.
In this phase III trial performed in Europe and other regions, 506 patients with advanced stage idiopathic Parkinson's disease were randomised. 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 system was added to stable levodopa treatment. The primary parameters were changed from baseline in the absolute 'off' time (US) and response rate (Europe). Response was defined as a decrease in absolute 'off' time from baseline by at least 30%. Non-inferiority to pramipexole was also shown. The most common adverse events associated with the use of rotigotine transdermal system were application site reactions as well as nausea and vomiting.
"In this trial, rotigotine transdermal system as adjunctive therapy in patients with advanced stage Parkinson's disease showed good efficacy, tolerability and safety. We are especially encouraged by the noticeable increase in 'on' time without troublesome dyskinesia, an important parameter for patients," said Iris Loew-Friedrich, member of the executive board Schwarz Pharma AG.
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.
Schwarz Pharma AG develops and markets innovative drugs for unmet medical needs with focus on 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.