Neupro- Early-stage Parkinson’s treatment

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Companies:

UCB and Schwarz Pharma

Pharmacologic class:

Dopamine agonist (non-ergot)

Active ingredient:

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

Indication:

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

Pharmacology:

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 hours of patch application. The drug is detectable in plasma about three 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.

Clinical trials:

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 4 mg/24 hours and 6 mg/24 hours; an 8-mg/24 hours dose had a similar effect as the 6-mg/24 hours 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 with those treated with placebo.

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

Adults:

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

Children:

Not recommended.

Precautions:

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. Asthma (sulfite sensitivity). Dyskinesia. Severe hepatic impairment. Monitor for melanoma. Pregnancy (Cat. C). Nursing mothers: not recommended.

Interactions:

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

Adverse reactions:

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

How supplied:

Patches—7, 30

For more information, call 800.477.7877 or visit www.Neupro.com

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