Investigational Patch for Parkinson's Eliminates Morning "Down Time"

From the First World Parkinson’s Congress

WASHINGTON, DC—The first investigational drug delivered via a transdermal patch that is currently under FDA review could be the answer to a major problem for patients with Parkinson’s disease (PD)—getting a good start in the morning—researchers reported at the first World Parkinson’s Congress.

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“A great problem with treating Parkinson’s patients is that at night they do not get their drugs,” lead investigator Nir Giladi, MD, director of movement disorders, Tel Aviv Medical Center, Israel, told . “So they wake up in an ‘off’ state and are often unable to move or get out of bed. This creates major problems for patients and caregivers, when bathroom and other morning needs are pressing.”

The study examined the effects of adding the rotigotine (Schwarz) patch to standard levodopa treatment on patients’ “off” time (ie, when a medication’s effects wear off and symptoms reappear).

A total of 506 patients with advanced-stage PD that was inadequately controlled with levodopa were randomly assigned to add-on rotigotine (n = 204), pramipexole (Mirapex; n = 201), or placebo (n = 101).

Patients in the rotigotine group received a once-daily patch treatment with a dose ranging from 2 to 16 mg. Those in the pramipexole group received up to 4.5 mg orally 3 times daily.

The average reported decrease in “off” time over a 24-hour period was 2.44 hours for rotigotine, 2.82 hours for pramipexole, and 0.88 hours for placebo. Average increase in time spent without troublesome motor-related side effects was 2.9 hours for rotigotine, 2.6 hours for pramipexole, and 1.2 hours for placebo.

"We applied the patch the day before, and?patients were much better than usual the next morning. We have never seen this before with drugs that are given orally."

?Nir Giladi, MD

The overnight and steady delivery of rotigotine could be its greatest asset. “We applied the patch the day before, and there was a steady delivery of the drug. Patients were much better than usual the next morning,” said Dr Giladi. “We have never seen this before with drugs that are given orally. It gives a big therapeutic advantage to this patch-delivered treatment.”

The gold standard for the treatment of PD is levodopa, which is found in several drugs, but the dopamine neurotransmitter that the brain requires for the proper motor functioning of muscles fluctuates during levodopa treatment. As a result, motor control is eventually lost, producing the characteristic symptoms of the disease.

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“Rotigotine transdermal patch administered once daily reduces the frequency and severity of Parkinson’s disease symptoms, and it has a high tolerability. This is good news for patients,” Warren Olanow, MD, professor and chairman of the Department of Neurology and professor of neuroscience at the Mount Sinai School of Medicine, New York City, told .

Rotigotine mimics the action of dopamine and effectively makes the brain “think” it is receiving dopamine; it is designed as an adjunctive therapy to levodopa. Rotigotine has been approved by the European Agency for the Evaluation of Medicinal Products.