Schwarz Pharma announced that the multinational phase IIb trial with rotigotine for the treatment of Restless Legs Syndrome (RLS) has shown a statistically significant and clinically relevant reduction of RLS symptoms. In addition the patch was well tolerated. Schwarz Pharma is preparing the phase III clinical development programme, which is scheduled to start in spring 2005.
Iris Loew-Friedrich, member of the Executive Board Schwarz Pharma AG said, "We are encouraged by the magnitude of the reduction of RLS symptoms and the good tolerance, which patients experienced during the trial. The improvement has been measured with the accepted IRLSSG scale and a meaningful clinical effect was observed within the first seven days of treatment."
Rotigotine is a novel dopamine receptor-agonist for the treatment of RLS formulated as a continuous delivery system, a patch. This silicone-based patch is applied once a day and administrates for 24 hours rotigotine transdermally to the body.
The multi-centre, double-blind, placebo controlled clinical trial had a treatment duration of six weeks. 310 patients with idiopathic moderate to very severe Restless Legs Syndrome (RLS) completed the trial. The primary parameter was the "International Restless Legs Study Group" (IRLSSG) scale. The most frequent adverse events occurring during the trial were application site disorder, nausea, vomiting and headache.
In addition, it is planned to submit applications for marketing approval for rotigotine for the treatment of Parkinson's disease in the third quarter of 2004.
Up to nine per cent of the population suffer from this neurological disorder, which is characterized by creepy, crawly sensations in the legs and an unpleasant spontaneous leg movement. Symptoms often appear during rest, but primarily occur in the evening and at night preventing restful sleep. This can lead to daytime tiredness. It is suspected that the cause is a disorder of neural metabolism. RLS is a chronic and slowly progressing disease that occurs approximately as frequently as migraines or diabetes. Dopamine agonists are thought to be an efficacious treatment option.
Schwarz Pharma develops innovative drugs with the focus on neurology and urology. There are currently seven projects in clinical development. In the last stage of development, phase III are Harkoseride to treat epilepsy and neuropathic pain and fesoterodine for the treatment of urinary incontinence.