The patch is baaaack ... Neupro is FDA-approved for PD!!!!

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. COMEBACK

An 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Developed by pharmaceutical company UCB and initially approved by the FDA in 2007, Neupro patches were withdrawn from the U.S. market in April 2008 when a manufacturing problem made it impossible for UCB to guarantee proper dosing.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.

http://www.ucb.presscentre.com/News/Neupro-approved-by-U-S-FDA-for-Parkinson-s-Disease-and-Restless-Legs-Syndrome-2d6.aspx


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®.

lizzy4451

You know my mom was on it the year it was recalled. She was only using it for a week before I told her doctor that didn't work for my mom because it was causing nights sweat. I wonder if that's the issue for the recall - being that it was absorbed too quickly? I don't remember how well it stayed on after a bath or if it will lose some of its potency when it's wet. I would love all her meds to come in patches so I won't have to deal with constant dosing of all her drugs throughout the day.

Someone please make a patch for Stalevo and I will be eternally grateful!

Why are you talking about a vibrator??!!????!!!!!Wierd

Post Edited (Leeson) : 4/26/2012 2:16:18 PM (GMT-6)