Neupro Availability Update for a Happy PD Thanksgiving

A Neupro Patch and Parkinson's Disease Discovery

Wishing everyone a Happy USA Thanksgiving.  We're trying to get ready for the family festivities but wanted to take a moment to share some information with you.

We found something for which people in the US who had been using the Rotigotine patch, also known as the Neupro Transdermal Patch, might be able to give thanks.

Because it is Thanksgiving day in the US, I won't be able to contact iBenefitRX to verify their statements of 6/30/09, but it appears that there is a way for those with a prescription might be able to order this medication without waiting for months and months for it to complete its second FDA process.

We are posting a link to their website article about being able to obtain Neupro through an affiliate.  The rest of the work is up to you.

Here's the iBenefitRX link to Neupro and the direct link to Customer Service email.

We last wrote about Neupro in August 2009 when the prospects looked dismal but it turns out that we didn't ask the right questions.  Thanks to Anonymous whose comments in the August article are worth a read, we've taken another look and that is how we found the information above.  Let us know what happens.

And don't forget, if you like the turkey breast meat, play the PD card and explain that it is better for you...because it is. Let's hope the wishbone does its magic.

Happy Thanksgiving

2010 Addendum:  There are other, longer established online pharmacies online.  We found the site in the article quickly and set up a link but did not do more research.  We have done some of it now but are not too happy with the results.

You might be interested in a few more and ways to verify the company you are considering. 

Check company trail through a domain search   This will tell you how long the site has been in use. You are looking for a legitimate existing business.   

You can use the following links at the Canadian International Pharmacy Association (CIPA) to verify accreditation of the pharmacy you are considering.

to verify membership
or similar link to consumer safety  

It is important to note that even fraudulent sites are sporting the CIBA seal and credentials, so do not take those at face value.

Note: TheCanadianPharmacy.com which is a legitimate site, does NOT carry the patch so the seal issue is very confusing. 

Another site to check is The International British Colombia Pharmacy Association also has a list of requirements legitimate Canadian Internet Pharmacy must follow.  
Also make sure that there is a legitimate street address as well as phone numbers.  We did find 2 sites with exactly the same address. Of course many mailing stores offer mailboxes which come with a street and suite address. While prices were pretty similar at the two Toronto sites, one offered free shipping while the other did not.
One serious problem with ordering from a non-local store is that your credit card will be charged and you may never see the product. There are plenty of scam sites out there.  At lease one purports to operate in Canada but are actually in Mexico.  Others...who knows!

What's Happening with the Neupro Patch for Parkinson's disease

August 2009: Neurpro Update from UCB

Last week we mentioned that we were checking the status of the Neupro® rotigotine transdermal patch. Although the patch has been available in Canada and in Europe to Parkinson's disease patients, it is still not available in the US. Originally it was hoped that the patch might return to the US market by the end of 2009 but it now looks as if that will not happen until 2010.

At the end of July, UCB submitted extensive information on Neupro® and the cold-chain distribution system to the FDA. UCB is in dialogue with the FDA and is hoping to make Neupro® available to U.S. patients during 2010, subject to FDA approval of the cold-chain distribution system. The importance of the delivery system of the product is to prevent the crystalization issue which caused its removal from the market.

Neupro is currently being introduced in Europe as a treatment for people with moderate to severe restless leg syndrome (RLS).

Many people had wonderful treatment success with the Neupro® patch delivery system only to find their lives turned upside down when it was removed from the market. They and especially PwP families have told their stories at many internet sites. It is not too late to send your stories to UCB as we mentioned in May 2009. The FDA is not without heart but they have a heavy responsibility to the public safety.

To send your story you can use this email address.

Please put "Share Neupro - Parkinson's disease stories/experiences with UCB" in the subject line.

The email body should begin: Attn: Joanne C, Medical Information.

We've written about about Neupro® in these articles. There is no question but that it became an effective treatment for many Parkinson's disease patients worldwide.

Addendum April 16, 2012
Look for the patch to be back at your pharmacy in July, 2012.  The FDA finally approved the new version of the Neupro Rotigotine Transdermal Patch.

Rotigotine Transdermal Patch for Parkinson's Disease

When will the Neupro transdermal patch return to the US market?

The rotigotine patch was intended for patients in advanced stage PD per Schwarz Pharma's early press release in 2004. However, when it was approved for release by the European Commission and launched by Schwarz Pharma as Neupro in 2006 in Europe it was for treatment of the early stages of Parkinson's disease. By 2008 it was approved for both early and late stages of PD.

The Neupro patch was intended as an adjunct therapy to reduce the "off" time without the dyskinesias typically associated with levadopa meds, dopamine antagonists. It is a 24 hour continuous release patch to maintain a steady level of rotigotine, the active ingredient. In trials it was found that "off" time was decreased by 30%. Side effects were site reactions to the patch as well as sleepiness, insomnia, dizziness and nausea which are not unusual in dopamine agonists.

By 2007 it had been learned that the patch was effective for YOPD in controlling symptoms. Motor scores evaluated using UPDRS were quite improved. It was approved by the FDA for US release in May, 2007. In 2008 it was approved for use in Restless Leg Syndrome (RLS) by the European Commission.

For many patients the patch meant a reduction in other medications and less "off" time as described. As with any medication, some people could not cope with side effects which appeared to include a change in blood pressure. For many people the patch was a wonder in reducing meds and maintaining "on" time.

And then in March 2008 the nightmare began for many PD patients when the patch was recalled. Out of stock was anticipated for April of 2008 in the US with limited out of stock in Europe as only certain batches were being recalled. One problem was that although the switch to Neupro could take place overnight, the withdrawal from it needs to be gradual.

By June of 2008 the European Medicines Agency issued a press release recommending changes in the storage information on the package. Because there had been some crystallization of the rotigotione in the packages, refrigeration was recommended to reduce the formation of crystals. Patients were also advised to not stop using the patch despite the presence of snowflake patterns on the patch. If the lack of supply dictated that they must stop using it, they were provided gradual withdrawal instructions or down-titration which we list below.

It is interesting to note that patients who did find the crystalline snowflake pattern indicated that the patch was just as effective as patches without the formation.

The patch was put back on the market in various European countries but in the US the FDA requested that the product be resubmitted completely free of the crystallization issues. The when it will return to the US market remains to be seen. There are several sites for clinical trials listed below. Oh yes, Neupro is also available in Canada.

At this time UCB, a Belgian company owns about 87% of the Schwarz Pharma stock which it began acquiring in 2006.

* * * * * * * * * * * * * * * * * * * * * * * * * * * * * * *
An informative article about rotigotine - a non-ergot derived dopamine agonist
http://www.modernmedicine.com/modernmedicine/Focus+On/Rotigotine-The-first-transdermal-nonergot-derived-/ArticleStandard/Article/detail/476083

The letter to providers:
http://www.fda.gov/cder/drug/shortages/Neupro_US_Physicians.pdf The letter to patients from Neupro from UCB SA, the drug-maker:
http://www.neupro.com/Home/Home.asp As reported on Bloomberg:
http://www.bloomberg.com/apps/news?pid=20601085&sid=aezT4INwTTB0&refer=europe
As reported on Global Insight on 12/19/08
http://www.globalinsight.com/SDA/SDADetail15366.htm

Clinical trial for Rotigotine transdermal patch - phase III
now recruiting: ages 30 and up
both genders
Study locations: 61 locationshttp://clinicaltrials.gov/ct2/show/NCT00522379
this link includes all locations:http://clinicaltrials.gov/ct2/show/NCT00522379?show_locs=Y#locn
One Year open-label safety and efficacy trial for severe idiopatic RLS
http://www.sciencedirect.com/science?_ob=ArticleURL&_udi=B6W6N-4T9BXR3-8&_user=10&_rdoc=1&_fmt=&_orig=search&_sort=d&view=c&_acct=C000050221&_version=1&_urlVersion=0&_userid=10&md5=1d86da0b9084fbd50c91f8b5d2bed3eb

We will post the response from UCB-Schwarz Pharma when it is received
We did send a communication of inquiry concerning the timetable to UCB R&D
The web site makes it clear that they prefer no patient contact about treatment for diseases other than inquiries about product.
4/15/09 Update: our correspondence is moving from desk to desk at UCB-Schwarz-Pharma - we'll keep you posted.
We've been posing UPDATES regularly. For the most recent see: December 23, 2009.

Addendum

The April 2010 news about the USA return of the Neupro Transdermal Patch is not good.