My Experience in the Clinical Trial for the New FDA Approved Subcutaneous Levodopa Pump

 It took quite a while but the FDA has finally approved a new way for people with Parkinson's to get levodopa. It is a subcutaneous pump designed by AbbVie. The medication is Foslevodopa/Foscarbodopa and they have named the new pump Vyalev.  

Back in 2021, I joined the clinical trial. It was time intensive and I had to drive almost an hour and a half to and from the trial site once a week but I was excited to be part of a trial that I thought might make a difference for people with Parkinson's.  

In a nutshell, I only got to wear the pump for about a month. The doctor overseeing the trial recommended that I stop because I was having a lot of bruising and swelling at the injection site and the meds were sometimes pooling under my skin instead of going into my system. I was disappointed to have to stop but I was hoping that my experience in the trial gave the researchers some info that would be helpful. Now that it is on the market, I want to try it again.

So what was it like?

First off, I knew that I did not have the placebo when I woke up the first morning with no tremor. That was not normal for me. Something was very different.  

Almost from the beginning, I had issues at the point of insertion. The medication goes into your system through a small cannula that goes under your skin and is held in place with an adhesive patch. You wear the pump 24 hours and only detach it for bathing and swimming. For the trial, I was only allowed to insert the cannula on my abdomen. I am very active and exercise a lot. I'm not a doctor but my thought is that the cannula was moving around a lot under my skin causing the bruising and swelling and pooling of meds subdermally. We tried different methods to hold the cannula in place and rotated the insertion site often but after a month, it was recommended that I discontinue use and end my participation in the trial. I had friends in a trial for a similar pump made by Neuroderm and they were using different insertion sites and doing well with it. I asked if I could try a different insertion place like my flank, leg or arm but because it was a clinical trial, they had to stick to a certain protocol. I was disappointed because when the pump worked, it was a smooth ride. There was one day when I had no tremors for over 12 hours. It was the first time in years that I went that long with no tremors.

Would I recommend it?

Absolutely! I even want to try it again. Now that it is FDA approved, they are allowing different insertion points. I would like to see if that helps. I am a few years further into my Parkinson's than I was at the time of my trial and my days are full of ups and downs with my meds.  I think this could be a game changer for some.

I am not looking forward to having the pump attached to me again as it is large and bulky and they have not minimized it at all that I can tell. I can only hope and pray that the scientists are working on getting the technology into a smaller device. For now, I have to put up with Parkinson's, so I can put up with wearing a big, bulky medical device if it makes my quality of life better.  As I understand it, Medicare approval of the device will take some time so I may not get a chance to try the new device until mid-2025.  

The pros:

When it works, my off times were very minimal.

I could eat when I wanted. The medication bypasses the gut, so food was not an issue.

I didn't have to schedule my day around my medications.

The cons:

The pump is bulky and large and sometimes got in the way of activities.

If you disconnect the pump, you need to supplement with oral meds.

The medication has to be refrigerated so traveling with it will take some planning.

There are a lot of supplies to keep on hand: syringes, tubing, alcohol pads, insertion devices. These all take up space. I am anticipating that they will not inexpensive and again traveling with all this will be inconvenient.

There is some prep time needed. The medication has to be taken out of the fridge for a certain amount of time before using. The process of getting it all ready and inserting the cannula takes a little bit of time but I got used to it quickly and could complete it pretty fast.

The medication is carbidopa/levodopa so may have the same side effects as taking it orally. I am hoping that because the meds bypass the gut, I may not need as much, and maybe dyskinesias will not be as bad. Only time will tell and that time won't be until at least July so I will wait and keep my eye on the research for the next new development.

Let me know if you try this new device and how it is going!