ANA: 24-Hour Patch for Parkinson's Exhibits Staying Power

CHICAGO -- Parkinson's patients were able to control symptoms of early-stage disease for at least 85 weeks using a once-daily transdermal patch delivering investigational rotigotine, investigators reported here.

The patients were part of an open-label extension trial of the patch, which contains 2 mg to 6 mg of the rotigotine, a dopamine agonist.

Before the extension trial, the patch was compared with placebo in a six-month test of efficacy, reported Ray Watts, M.D., chairman of neurology at the University of Alabama at Birmingham, at the American Neurological Association meeting.

The 137 patients on the active medication showed an immediate reduction in scores on the Unified Parkinson's Disease Rating Scale of about seven points, he said, and after six months that score remained four points below baseline.

However, among the 79 patients who were administered placebo patches, the immediate reduction of four points slowly increased until at six months they were two points above baseline.

The six-point difference at six months, Dr. Watts said, reached statistical significance at the P<0.0001 level.

At the end of the trial, patients were invited to continue in an open-label extension. The patients who had been on placebo showed an immediate drop in the Unified Parkinson's Disease Rating Scale scores, but as with the patients who continued on rotigotine, the scores slowly rose during the 85 week total length of the study.

After 85 weeks, the patients who had been on rotigotine continuously were still two points below their Unified Parkinson's Disease Rating Scale baseline; the former placebo patients were two points above baseline.

Because the extension part of the study involved open-label bias, no P-values were calculated for the differences between the groups.

"We think that the patch can give patients at least two to three years of control of their Parkinson's disease symptoms," said Dr. Watts.

In addition to its efficacy versus placebo, Dr. Watts said the patch was generally safe and well tolerated with a low rate of discontinuance due to adverse effects.

"What makes the patch so good is that it delivers medicine continuously," commented Jeanne Rosner, director of the Parkinson's Information Service in Chicago, a division of the Parkinson's Disease Foundation. "Patients don't have to worry about when they have to take their drugs or whether they have taken their drugs."

She suggested that because the patches deliver medicine smoothly, they may protect patients by eliminating the stress on the body of going on and off medication. "We don't know that for a fact yet," she said, "but it is something we think may be happening to patients, and why after a while some of these medications lose potency in controlling the disease."

She said that the only down side to the patches are application side reactions and side effects that occur with any drug. She was not involved in the studies.

Overall, however, patients tended to tolerate the medicine very well, commented James Patton, M.D., a neurologist with Asheville (N.C.) Neurology Specialists, a private practice that also conducts pharmaceutical research. He reported studies of tolerance and safety of the patch in another presentation at the meeting which pooled data from three clinical trials.

The most common adverse events in the titration phase versus placebo were: nausea (35% vs. 12%), application site reaction (23% vs. 9%), dizziness (14% vs. 6%), vomiting (10% vs. 1%) and insomnia (6% vs. 3%). In the maintenance phase, the incidences of these adverse events were reduced: nausea (8% vs. 4%), application site reaction (19% vs. 6%), dizziness (6% vs. 5%), vomiting (4% vs. <1%) and insomnia (4% vs. 2%). Application site reactions were mostly mild or moderate in severity.

A total of 13% of rotigotine-treated patients discontinued due to an adverse event versus 6% of placebo patients.

Both presentations were funded by Schwarz Pharma of Monheim, Germany, the developer of the patch, and one of the authors of both abstracts is an employee of Schwarz Pharma.

"This is an exciting drug," Dr. Patton said. "Patients tolerate it very well. It's very safe. The patients' laboratory tests didn't change from using it." He said it can be worn through a shower, but most patients figure out that they should shower before putting on a new patch.