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PDF Update on Neuproģ Recall: FDA Issues Complete Response Letter
- Dec 19 2008
Earlier this year, the Parkinson’s Disease Foundation (PDF), issued a statement regarding UCB Inc.'s recall of Neupro® (rotigotine transdermal system), a treatment formerly used to ease the symptoms of Parkinson’s disease (PD) in its early stages.
Today, PDF learned that UCB has received a ‘Complete Response Letter’ from the US Food and Drug Administration (FDA) for Neupro to treat the signs and symptoms of advanced PD. A ‘Complete Response Letter’ demonstrates that the FDA has completed its review of a drug application, but believes it is not ready for approval
According to UCB, the FDA stated that although there is evidence to show the medication is effective in treating people with advanced Parkinson’s disease, it will not approve the medication for the treatment of advanced Parkinson’s until the ‘crystallization’ problem that led to its recall (caused by distribution and storage procedures) is corrected.
Neupro is a dopamine agonist, a dopamine-like drug that shows the same effectiveness as other available agonists, such as pramipexole and ropinirole. The novel aspect of Neupro is its once-a-day application in the form of a skin patch. It was first approved for use in the United States by the FDA in May 2007 for people with early stage PD.
It was recalled in April 2008, neither for safety concerns, like contamination or toxicity of the medication, nor for problems with the efficacy of the medication in its true form. Rather, regular monitoring of the patch revealed a problem in its manufacturing that deviated from the approved process. In some cases, this caused the medication to crystallize. Crystallization reduced the amount of the medication that was available to be absorbed through the skin, lowering its efficacy.
In Europe, the European Medicines Agency (EMEA) has approved use of the medication for people with Parkinson’s who were using the medication prior to the recall. This is because new manufacturing and distribution procedures have been implemented in Europe that are not yet being used in the US. The EMEA has not yet approved the medication for people with Parkinson’s who are new to the medication.
UCB says it will discuss the contents of the Complete Response Letter and the next steps with the FDA.
At this time unfortunately, we do not know when and if the treatment for people living with Parkinson’s in the US. We will keep you updated as we learn more information. If you have any additional questions, please call our helpline at (800) 457-6676 or Ask the Expert, using our online service.
Parkinson’s Disease Foundation
Source Date: Dec 19 2008