NPF Update on Neupro Patch
Release date: 4/26/2010
A message from Michael S. Okun, M.D., National Medical Director of NPF:
We at NPF are committed to continuing to update the Parkinson’s disease community on the Neupro (Rotigotine) dopamine agonist patch. The issue that precipitated removal from the market was a “crystalization” of the medication into what appeared to many as “snowflakes” on the surface of the patch. After scientific review, it was discovered that storage by refrigeration was a potential solution. The patch underwent review by the FDA, and they determined that to be re-approved for the United States market, the drug would need to be completely reformulated. This reformulation process could take as long as a year or two. In the meantime for those patients with Parkinson’s disease who continue to wait for the patch, please see your doctors to discuss alternative strategies with the many available medications that can be given by tablets.
We received an important update on the drug Neupro (Rotigotine patch) for Parkinson’s disease, which is currently available in Europe. As many Parkinson’s disease sufferers and family members are aware, the drug was removed from the market because of issues with crystal formation on the surface of the patch. Unfortunately, after much discussion and review, the FDA has recommended that the drug be reformulated--and it is estimated it will not reach the US market until 2012. In the meantime, if this product was useful for you or for a family member, we recommend speaking to your doctor about adjustments in dose and/or frequency of your Parkinson’s disease medications, and also looking into the extended release pill formulations for the dopamine agonists. We will keep you up to date with information as we receive it.
The UCB Press Release follows:
UCB Receives Complete Response Letter from U.S. FDA Regarding Neupro® (Rotigotine).
Brussels (Belgium) - April 23, 2010 - regulated information - UCB announced today that the U.S. Food and Drug Administration (FDA) has provided a complete response letter recommending reformulation of Neupro® (Rotigotine Transdermal System) before making it available in the U.S. market for the treatment of Parkinson's disease (PD) and restless legs syndrome (RLS). FDA's response is to an NDA Supplement that UCB submitted in June 2009, with a proposal for new refrigerated storage conditions to alleviate crystallization on the patches.
"FDA agrees that the proposed new refrigeration conditions significantly inhibit the degree of crystallization on the patches, but has recommended that the definitive resolution of the crystallization is to reformulate the drug product," said Prof. Dr. Iris Loew-Friedrich, Executive Vice President and Chief Medical Officer of UCB. "This FDA decision does not impact product supply and availability in Europe and the rest of the world. It does not change previous assessments made by the European and other international authorities regarding the cold chain storage process."
More than 50 000 patients are being treated by Neupro® in Europe. In the U.S., a Patient Access Program is ongoing and UCB will continue this program.
"We have already been working on a room-temperature stable, improved formulation of Neupro® and have made significant progress in this area," the Chief Medical Officer of UCB added. "Neupro® has made a meaningful difference for many people with Parkinson's disease and Restless Legs Syndrome. We are committed to obtaining FDA approval so that people in the U.S. who live with these diseases can benefit from Neupro."
The complete release can be viewed here.