Neupro Rotigotine Transdermal Patch Ordered Back to the Drawing Board

Parkinson's disease and Restless Leg Patients Will Have to Wait - FDA Has Ruled

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.
  

With the decision to order UCB to find a definitive solution to the crystallization issue which did not appear to negatively affect users, UCB will be back to redesign.  The FDA acknowledged that the new refrigeration conditions - the cold storage distribution would "significantly inhibit the degree of crystallization on the batches but" the order is to reformulate the product to definitively resolve the issue.

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.

Based upon the fact that reformulation could take at least a year or two and FDA approval would probably take as long as their denial, it may be 3 years before it is seen again in US pharmacies.  After approval, there would probably be a significant period of time to begin manufacturing and distributing.

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.   

On a personal note, we'd like to apologize for the delay in posting the Neupro-FDA information.  I found it so upsetting, that although Steve gave me the information immediately, I couldn't find the words to express my disappointment.

Previous Neupro posts:

March 14, 2010

On 3/11/2010, 12/23/2009, 12/11/2009

November 26, 2009 in a Thanksgiving hope

August 16,2009

April 10, 2009 in which we included many links about the patch.

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.

FDA Okays Embryonic Stem Cell Clinical Trials

According to a Geron Corp press release, the FDA is allowing Geron Corp to begin human clinical tests of embryonic stem cells (ESC) for the treatment of acute spinal injuries. Geron will use ESC to try to regrow nerve tissue in patients.

Although the FDA had received the request to begin clinical trials since May 2008, they remained silent until now - possibly still reading the 21,000 page document.

The FDA action coming just a few days after Obama became President is heartening to patients who have chronic diseases such as Parkinson's, juvenile diabetes, MS. ALS and many other illnesses. It holds great promise for new treatments and transplants.

Geron Corp (GERN) is a San Francisco, California based biotech company developing biopharmaceuticals for treatments of cancer and degenerative diseases. Shares are trading up as of the announcement.

addenda 1/24/09
for additional information refer to: http://www.medicalnewstoday.com/articles/136413.php
Commentary about action and use of adult vs embryonic stem cells:
http://www.medicalnewstoday.com/articles/136553.php

Parkinson's and the Global Financial Crisis

Since we appear to be in a recession in the US and around the world, we can expect it to effect private and publicly funded research into the causes and cure of Parkinson's Disease.

In the private sector there will be lower stock market and real estate profits which in turn could offset the ability to make large contributions. Major Parkinson's foundations, other medical foundations and universities will face the same increased costs and lower income problems as private companies. They will all need to cut costs by reducing services and cutting payrolls. Universities will probably have lower enrollments during the next few years because fewer prospective students will be able to get loans for tuition.

Parkinson's lobbying groups are trying to get an increase in the fiscal 2009 budget for NIH that will equal biomedical inflation. Whoever is President is going to need to make large cuts in the US budget. The climate will become colder for getting the needed increases.

Pharmaceutical companies often borrow money to fund research and development costs from one phase to the next. Their ability to do that is going to be difficult because of the credit freeze.

There is research in final stages and medications awaiting FDA approval. While some of these are adjuncts to existing treatments there may still be good news around the corner.