Companies:

UCB and Schwarz Pharma

Dopamine agonist (non-ergot)

Rotigotine 2mg/24 hours, 4mg/24 hours, 6mg/24 hours; transdermal patch; contains sulfites.

Treatment of patients with early-stage idiopathic Parkinson’s disease who are not receiving concomitant L-dopa.

Neupro is a transdermal patch containing rotigotine, a D₃/D₂/D₁ dopamine agonist. The mechanism of action of rotigotine in treating Parkinson’s disease may be due to its ability to stimulate D₂ receptors in the caudate-putamen.

About 45% of the drug is released within 24 hrs after applying the patch. The drug is detectable in plasma about 3 hours after application, and maximum plasma concentrations are usually reached between 15 and 18 hours post-dose. Steady-state levels are achieved within 2–3 days of daily dosing.

Three double-blind placebo-controlled studies were conducted to evaluate the effectiveness of Neupro in treating the signs and symptoms of early-stage idiopathic Parkinson’s disease. Patients were not on other dopamine agonists or L-dopa during the trials. The primary outcome assessment was the change from baseline for the combined scores for part II (activities of daily living) and part III (motor component) of the Unified Parkinson’s Disease Rating Scale (UPDRS).

A dose-response study indicated that statistically significant mean changes reflecting dose-related improvement were seen for the marketed doses of 4mg/24 hrs and 6mg/24 hrs; an 8mg/24 hrs dose had a similar effect as the 6mg/24 hrs dose. In the North American study, patients treated with Neupro had a mean change in the UPDRS from baseline to end of treatment that was statistically significant compared to those treated with placebo.

In a three-arm foreign multinational study that compared Neupro to an active, oral comparator and to placebo, patients treated with Neupro at doses up to 8mg/24 hrs had a mean change in the combined UPDRS from baseline to the end of treatment that was statistically better than those given placebo.

Apply to clean, dry, intact skin on abdomen, thigh, hip, flank, shoulder, or upper arm. Initial: apply one 2mg/24 hrs patch once daily; may increase weekly by 2mg/24 hrs; max one 6mg/24 hrs patch once daily. Rotate application site (allow 14 days before reapplying to same site). Shave site at least 3 days before application if hairy. Do not cut patch. Avoid abrupt cessation; reduce by 2mg/24 hrs every other day.

Not recommended.

Avoid external heat sources. Remove patch before cardioversion, MRI. Consider discontinuing if excessive daytime sleepiness or falling asleep during activities occurs. Cardiovascular disease. Conditions aggravated by fluid retention (eg, CHF). Asthma (sulfite sensitivity). Dyskinesia. Severe hepatic impairment. Monitor for melanoma. Pregnancy (Cat.C). Nursing mothers: not recommended.

Additive CNS depression with alcohol, CNS depressants. May be antagonized by metoclopramide, antipsychotics.

Somnolence (may be sudden), dizziness, GI upset, application site reactions, headache, insomnia, weight change, lab abnormalities; orthostatic hypotension, syncope, hallucinations, intense urges/compulsions, others.

Patches—7, 30

For more information call (800) 477-7877 or visit www.Neupro.com.

6/27/07