Yesterday,April 3, the FDA announced it has again approved the Neupro patch for use for Parkinson's disease. The press release and excerpt is below.
You may recall that the Neupro patch was previously approved by the FDA for PD. However, there was an issue with the delivery mechanism - the patch itself. The patch sometimes caused the medication to crystalize on the patch leading to an uneven and unpredictable delivery of the medication. Therefore, the FDA withdrew their approval.
Neupro is a dopamine agonist. Other dopamine agonists are Requip and Mirapex. The advantage of the Neupro patch is that it provides an even distribution of the medication. The patch, which comes in multiple sizes based on dosage, is replaced daily. It was well-tolerated by a lot of people before it was pulled from the US market.
Read what others are saying:
The Michael J Fox Foundation ...
NEUPRO PATCH READY FOR LONG-AWAITED U.S. COMEBACKAn important development today for Americans with Parkinson’s disease (PD): Neupro, the only extended-release dopamine agonist in the form of a skin patch, has been approved by the U.S. Food and Drug Administration (FDA) to treat the symptoms associated with both early and advanced stage PD, and is expected to return to pharmacy shelves this July.
Developed by pharmaceutical company UCB and initially approved by the FDA in 2007, Neupro patches were withdrawn from the U.S. market in April 2008 when a manufacturing problem made it impossible for UCB to guarantee proper dosing. Now, it appears, those concerns have been addressed.
“The specific benefit of Neupro, like other extended-release dopamine agonists, is that it maintains as constant a level of drug as possible throughout the day, which could translate into longer ‘on’ periods for people with Parkinson’s,” says MJFF associate director of research programs Maurizio Facheris, MD.
The National Parkinson Foundation ...
NPF Statement on the FDA Approval of the Neupro® Patch"It is terrific news for the Parkinson's disease community that the Rotigotine patch has been
re-approved. Because Parkinson's disease patients typically have to take many doses of medications each day, the re-approval of the patch will hopefully help a lot of sufferers."
— Dr. Michael S. Okun, National Medical Director of the National Parkinson Foundation
Click on the link below for the press release.
Excerpt from the UCB press release:
Neupro® approved by U.S. FDA for Parkinson's Disease and Restless Legs Syndrome
April 3, 2012 — UCB announced today that the U.S. Food and Drug Administration (FDA) approved Neupro® (rotigotine transdermal system) for the treatment of the signs and symptoms of advanced stage idiopathic Parkinson's disease (PD) and as a treatment for moderate-to-severe primary Restless Legs Syndrome (RLS). Neupro® was previously approved by the FDA for the signs and symptoms of early stage idiopathic PD. Neupro® is a dopamine agonist patch that provides continuous drug delivery for patients with PD and RLS. The FDA has also approved UCB's new formulation of Neupro®.
Life is a dance. Don't sit it out. ---- Jackson H. Brown