SCHWARZ RELEASES SAFETY DATA FROM TRIAL OF PARKINSON'S PATCH

Schwarz Pharma has announced that its rotigotine transdermal patch demonstrated a favorable safety and tolerability profile during both the titration and maintenance phases of three clinical studies, including two Phase III trials. Additional data in a subset of 79 patients included an encouraging tolerability profile in patients over the age of 75. The combined analysis included early-stage Parkinson's disease patients up to 86 years of age. This data showed that the transdermal dopamine agonist may be a useful treatment option in both younger and older Parkinson's patients.

The combined analysis included results from three randomized, double-blind, placebo-controlled studies (one Phase II and two Phase III studies) with a total of 938 patients (649 received rotigotine therapy, 289 received placebo).

The overall incidence of adverse events during the titration phase was 74 percent on rotigotine versus 64 percent on placebo. In the maintenance phase, the overall incidence of adverse events was slightly higher in the placebo groups than in the rotigotine groups (64 percent versus 62 percent). The most commonly observed adverse events with the use of rotigotine were application site reactions.

Rotigotine is a non-ergolinic dopamine receptor agonist formulated as a transdermal patch designed for once-a-day application. Rotigotine is designed to mimic the action of dopamine, a naturally produced neurotransmitter crucial for proper motor functioning. The patch is currently under review with the FDA for its efficacy and safety as treatment for early-stage Parkinson's disease. It is marketed in Europe as monotherapy for early-stage Parkinson's.