Friday, April 10, 2009

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.

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An informative article about rotigotine - a non-ergot derived dopamine agonist

The letter to providers: The letter to patients from Neupro from UCB SA, the drug-maker: As reported on Bloomberg:
As reported on Global Insight on 12/19/08

Clinical trial for Rotigotine transdermal patch - phase III
now recruiting: ages 30 and up
both genders
Study locations: 61 locations
this link includes all locations:
One Year open-label safety and efficacy trial for severe idiopatic RLS

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.

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

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