Rotigotine Appeared to Be a Safe Treatment for Early-Stage Parkinson's Disease in Clinical Studies


10/10/06 -- SCHWARZ PHARMA today announced at the 131st Annual Meeting of the American Neurological Association (ANA) that rotigotine transdermal patch demonstrated a favorable safety and tolerability profile during both the titration and maintenance phases of three clinical studies.

Additional data in a subset of 79 patients included an encouraging tolerability profile in patients over the age of 75. Use of dopamine agonists in the over 75 population is often limited because of the potential for increased adverse reactions.

The combined analysis presented included early-stage Parkinson's disease (PD) patients up to 86 years of age. This data showed that the transdermal dopamine agonist, rotigotine, may be a useful treatment option in both relatively younger and older PD patients.


Rotigotine is currently under review with the U.S. Food and Drug Administration (FDA) for its efficacy and safety as treatment for early-stage PD.

It is marketed in Europe as monotherapy for early-stage PD. An application for rotigotine for the treatment of advanced-stage PD as combination therapy with levodopa was submitted in Europe at the end of June.

"These data demonstrate that rotigotine appeared to be a tolerable and safe therapeutic option for a variety of Parkinson's disease patients, including those over the age of 75," said Michele Tagliati, MD, associate professor of neurology at Mount Sinai School of Medicine and Director of the Parkinson's Disease Center.

"Formulated as a once-daily transdermal patch, rotigotine has the potential to provide Parkinson's patients with a safe and effective treatment option in an innovative delivery system."

About the Pooled Analysis

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 placebo and rotigotine groups were similar in baseline with respect to age, gender and PD severity.

Safety Results

The overall incidence of adverse events (AEs) during the titration phase was 74 percent rotigotine versus 64 percent placebo. In the maintenance phase, the overall incidence of AEs was slightly higher in the placebo groups than in the rotigotine groups (64 percent versus 62 percent, respectively).

AEs that are typically seen with dopamine agonists (including nausea, somnolence [drowsiness], dizziness and vomiting) decreased as the patient stayed on medication. In the analysis, the most commonly observed AEs with the use of rotigotine were application site reactions (ASRs). ASRs are a common side effect with transdermal patches and, in the case of rotigotine, reactions were generally mild or moderate.

Other than ASRs, there were no AEs in the rotigotine group during the maintenance phase that occurred at an incidence of greater than 10 percent. Rate of study discontinuation due to AEs was similar in patients taking rotigotine and patients on placebo therapy (13 percent versus 6 percent, respectively).

Age-Related Results

A sub-analysis examined the incidence of AEs in early-stage PD patients in two age populations: those under the age of 75 (602 rotigotine patients and 257 placebo-treated) and those over 75 (47 rotigotine patients and 32 placebo- treated). These results suggest that rotigotine treatment may be safe in patients over the age of 75.

Patients over the age of 75 reported lower rates of nausea (26 percent versus 39 percent, respectively) and vomiting (6 percent versus 13 percent, respectively) compared to patients under the age of 75.

In these three trials, the older patient group of rotigotine-treated patients did not experience hallucinations, as compared to 2 percent of patients less than 75 years of age. This analysis is limited due to the small number of patients in the older subgroup.

About Rotigotine Transdermal Patch

Rotigotine is a non-ergolinic dopamine receptor-agonist formulated as a transdermal delivery system, a 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.

SCHWARZ PHARMA filed a New Drug Application (NDA) for rotigotine with the FDA in January 2005 and with the European Agency for the Evaluation of Medicinal Products (EMEA) in September 2004 for the treatment of early-stage Parkinson's disease. SCHWARZ PHARMA received an approvable letter from the FDA on February 28, 2006. Rotigotine was approved by the EMEA on February 20, 2006.