Rotigotine transdermal system approved for Parkinson's disease in US
May 17, 2007 - 1:36:06 AM
, Reviewed by: Dr. Himanshu Tyagi
|
|
|
Neupro is the first transdermal patch approved for the treatment of symptoms of Parkinson's disease.
|
|
Key Points of this article
|
|
Rotigotine is a drug not previously approved in the United States.
|
|
|
|
|
Main results
|
|
The effectiveness of Neupro 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 Parkinson's medications.
|
|
|
Rotigotine
|
|
Rotigotine, a member of the dopamine agonist class of drugs, is delivered continuously through the skin (transdermal) using a silicone-based patch that is replaced every 24 hours. A dopamine agonist works by activating dopamine receptors in the body, mimicking the effect of the neurotransmitter dopamine.
|
|
|
Epidemiology
|
|
According to the Parkinson's Action Network, more than 1 million Americans live with Parkinson's disease and 60,000 new cases are diagnosed each year. The four primary symptoms of Parkinson's are trembling in hands, arms, legs, jaw, and face (tremor); stiffness of the limbs and trunk (rigidity); slowness of movement (bradykinesia,); and impaired balance and coordination (postural instability). As these symptoms become more pronounced, patients may have difficulty walking, talking, or completing other simple tasks.
|
|
By FDA,
[RxPG] The U.S. Food and Drug Administration (FDA) today announced the approval of Neupro (rotigotine transdermal system), a skin patch designed to treat symptoms of early Parkinson's disease. Rotigotine is a drug not previously approved in the United States. Neupro is the first transdermal patch approved for the treatment of symptoms of Parkinson's disease.
Parkinson's disease, which belongs to a group of conditions called motor system disorders, results from the loss of dopamine-producing brain cells. Rotigotine, a member of the dopamine agonist class of drugs, is delivered continuously through the skin (transdermal) using a silicone-based patch that is replaced every 24 hours. A dopamine agonist works by activating dopamine receptors in the body, mimicking the effect of the neurotransmitter dopamine.
The effectiveness of Neupro 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 Parkinson's medications.
The most common side effects for Neupro 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 sudden onset of sleep while engaged in routine activities such as driving or operating machinery (sleep attacks), hallucinations, and decreased blood pressure on standing up (postural hypotension).
Advertise in this space for $10 per month.
Contact us today.
|
 |
|
Subscribe to Parkinson's Newsletter
|
|
|
|
About Dr. Himanshu Tyagi
|
This news story has been reviewed by Dr. Himanshu Tyagi before its publication on RxPG News website. Dr. Himanshu Tyagi, MBBS is the founder editor and manager for RxPG News. In this position he is responsible for content development and overall website and editorial management functions. His areas of special interest are psychological therapies and evidence based journalism.
RxPG News is committed to promotion and implementation of Evidence Based Medical Journalism in all channels of mass media including internet.
|
|
Additional information about the news article
|
Neupro Patch is manufactured by Schwarz Bioscience of Research Triangle Park, N.C.
|
|
Feedback
|
For any corrections of factual information, to contact the editors or to send
any medical news or health news press releases, use
feedback form
|
Top of Page
|
