Yesterday was my quarterly visit to the Neurologist who monitors my participation in the Phase 4 clinical trial to get the Neupro patch approved by the F.D.A. for distribution in the United States.

I am wearing 6mg of Neupro each day. That means that I wear two patches each day, one 2 mg and one 4 mg. I’m told that I wear the least amount of this drug compared to the rest of the participants in the study from my doctor’s office. That doesn’t matter a bit to me – the patches work and that’s all I care about. There are too many RLS and PWP who need this drug NOW. I just want to get it back on the market in the U.S. I wish the FDA and Schwarz Pharma could read just a few of the letters, emails and comments I receive from people who are desperate for the relief the Neupro patch gives them because they cannot tolerate the alternatives.

During this infernal heat wave in Texas I’ve had problems with the patches staying on my body. It seems that the adhesive isn’t very effective when it’s hot. Of course, the insert warns that one should not wear the patch in the sauna, hot baths or showers, etc. But, I guess Schwarz Pharma in Germany and Minnesota don’t understand that in parts of the Southwestern United States we have 100+ temperatures and 70% humidity daily for months on end.

So, one of the newest developments in the Neupro patch is that Schwarz Pharma has changed the adhesive formulation. I’ll let you (and them) know if this is effective. All of the participants in this trial have complained that the former patch adhesive was crummy and didn’t work. Of course, the temperatures in Texas have since cooled down and we’re having rain and 70 degree temps this week. But, my body temperature always runs hot, so we’ll see how these stick.

Another new development in this Phase 4 clinical trial is that Schwarz Pharma only provided 2 months worth of patches (instead of 3 months) to the participants. The explanation given was that they have so many participants in the trial that they didn’t manufacture enough patches for everyone to have 3 months worth. Hmmmm, sounds a little fishy to me, what do you think?

Because I’m basically a suspicious and not very trusting individual, I think Schwarz Pharma is only providing 2 months worth of patches because they are almost ready to release these Neupro patches back on the market in the United States. We all know that Canadian pharmacies are now prohibited from selling the Neupro patch to Americans. That usually happens when a drug is about to be approved for distribution in the neighboring country. That happens so that the country that is about to get the drug isn’t already a saturated market when the drug is released. I hate the game playing that goes on to get FDA approval of this drug.

People, we already KNOW the Neupro patch works. We already KNOW that the manufacturing and distribution processes needed to be changed to get the crystals to stop forming on the patch. This drug trial has been in Phase 4 for almost 18 months now. It’s past time for the Neupro patch to be approved for use in the United States.

Whatever politics are being played out because Schwarz Pharma is a German company, OR whatever hoops are being put in place at the last minute by the FDA, let’s get all of this resolved. Sure, this is not a “life or death” matter for humans like drugs that are being developed for AIDS or cancer. But, if you had to suffer ONE DAY with your limbs having crawling bug-feeling things, or your legs jerking around uncontrollably for hours, YOU would want your solution immediately too!

So, I’m praying the FDA and Schwarz Pharma get their acts together before the next 2 months and surprise all of us in the Parkinson’s community. I’m praying that the Neupro patch is release before November. Folks with RLS and PWP in the U.S. need a break. Please don’t delay the relief of our misery any longer.