The news for US Parkinson's Disease patients waiting for an early FDA clearance of the Neurpro patch formulation is not good. On April 23, 2010 UCB announced the receipt of the FDA response letter. The FDA informed UCB Pharma that it will have to resolve all crystallization issues with the Neupro® patch. Apparently the policy is zero tolerance despite the fact that the patch was returned to the European market about 10 months ago.
We already knew that if the patch received approval (again) from the FDA that there would be a delay while the new patches were produced. In all likelihood, the news would not have been officially released until the patches were on their way throughout the US to pharmacies for cold storage. This delay would have put the availability back to the end of 2010.
From the 4/23/10 announcement: "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 good news for PD patients around the world with the exception of the USA are the results of the RECOVER study were presented in at the American Academy of Neurology annual meeting in Toronto, Canada in April, 2010. The data demonstrated the rotigotine improved both early morning motor function and improved non-motor symptoms in Parkinson's patients. Symptoms such as sleep, mood, cognition and pain were measured and found to be improved. Nocturia, night time excessive urination remained unchanged and there were some adverse events such as site reactions, nausea and dizziness in both the rotigotine group and the placebo group. Rotigotine was shown to be effective up to 6 years and provided improvement in movement symptoms for up to 6 years.
In another study the Neupro® Rotigotine Transdermal Patch was shown to provide sustained benefit for Restless Leg Syndrome.
One thing to remember is that rotigotine is a dopamine agonist and as such there are also side effects. It is unlikely that reformulation will alter those side effects because of the class of the medication. For the people who have been helped by this medication, its loss was quality of life altering.
We wonder why the the FDA did not allow for a provisional approval for, say 2-3 years, while UCB worked to meet the present requirements. Based upon the fact that the medication is on most of the world market already, it would be the humane thing to do.
Addendum: On April 3, 2012 UCB announced that the FDA has approved the revised patch. UCB has targeted July 2012 as for the return to the US market.