FDA approves rotigotine patches for
Parkinson’s disease
Dopamine agonist provides additional
option in patients with early disease.
Rotigotine (Neupro—Schwarz Pharma), a dopamine agonist
formulated in a transdermal patch, has been approved by FDA for
treatment of the signs and symptoms of early-stage idiopathic
Parkinson’s disease. Applied once daily, the patch will be
available in the United States in three strengths, 2, 4, and 6 mg. The
drug was approved in Europe in March 2006 and is currently available in
14 countries there.
The effectiveness of rotigotine was demonstrated in one fixed-dose
response study and two flexible-dose studies. The parallel group studies
were randomized, double-blinded, and placebo-controlled, and involved
1,154 patients with early Parkinson’s disease who were not taking
other antiparkinsonian medications. The trials demonstrated safety and
efficacy of the drug and indicated a low potential for drug
interactions.
The most common adverse effects in rotigotine clinical trials included
skin reactions at the patch site, dizziness, nausea, vomiting,
drowsiness, and insomnia, most of which are typical of this class of
drugs. Other potential safety concerns include sleep attacks (sudden
onset of sleep while engaged in routine activities, including driving or
operating machinery), hallucinations, and postural hypotension.
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Contact the writer: L. Michael Posey, BPharm, Pharmacy
Today
Posted May 10, 2007, 5:10pm EDT
| Dopamine agonist provides additional option in patients with early disease. |
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