[Webinar Recording] October 2024 Living With Parkinson’s Meetup: Exenatide, Infusion Levodopa, and Advice

VYALEV And Exenatide: overview 

A few days before the meetup, the top-line results of a phase 3 trial of exenatide were released, and just a few hours before the October meetup, the FDA approved VYALEV, a formulation of carbidopa/levodopa that is delivered continuously throughout the day using a pump called Vyafuser. The panelists decided to shift from their planned discussion for the day and instead talk about these important developments.

Background about EXENATIDE

The phase 3 trial of exenatide, which was based in the United Kingdom, was designed to measure whether exenatide slowed progression of Parkinson’s. Despite that previous, earlier phase trials indicated exenatide may slow progression, the phase 3 trial failed to demonstrate that exenatide had this effect.

The panelists expressed both disappointment about this development and gratitude for everything learned about Parkinson’s being a step toward improvement, even when the news–or in this case the results of a trial–seems, on the surface, to be negative. Even when a prospective treatment turns out not to be effective, science advances and new possibilities for deepened understanding open up.

Background about VYALEV

In a blinded-study, people with Parkinson’s who took VYALEV and immediate-release oral carbidopa/levodopa experienced a 1.75 hour greater increase in ON time without dyskinesia compared to people taking just immediate-release oral carbidopa/levodopa and placebo. In the same study, those taking VYALEV experienced a 1.79 hour greater decrease in OFF time. In an open-label study, results related to ON and OFF time were similar to those in the blinded study referenced above, and researchers reported additional benefits, including decrease in morning akinesia (significant mobility impairment upon waking), improvements in sleep outcomes, and improvements in motor experiences of daily living. 

While the panelists observed that continuous infusion carbidopa/levodopa won’t be right for everyone and that there are still several steps that must be taken before it becomes widely available, several expressed optimism about the therapy and what it means for the Parkinson’s community. Kat, who was part of a focus group several years ago that centered around the treatment, said she thinks that for many people it will be a game changer.   

Below are a few benefits of VYALEV that the panelists mentioned:  

• The system administers levodopa through continuous infusion via a pump, similar to an infusion of insulin used by some people with diabetes.  

• The settings allow you and your care team to set a rate of infusion and add more or less at certain times, like before you exercise or go to sleep. 

• Infusion levodopa provides an alternative, non-surgical treatment option for people living with Parkinson’s who have challenges swallowing pills or remembering to take their doses of oral medication. 

• Unlike Duopa, VYALEV doesn’t require surgery. 

As with all treatments, of course, there are possible side effects and challenges that can arise from VYALEV therapy. Infusion site reactions and infections can occur, and people with skin sensitivities and allergies should be especially aware of these possibilities. The system also includes parts that must be changed frequently, which could be challenging depending on your symptoms.  

The panelists also stressed that while the news about continuous infusion carbidopa/levodopa is exciting, it’s important to remember that the system is new and unique, so those who prescribe VYALEV will need time to learn about the details of the system, including the calculations associated with determining a person’s optimal dosing regimen. And, as with any new drug, insurance providers will need time to determine costs and coverage requirements.  

Whether or not this new therapy ends up being a good fit for you, the news is noteworthy. The panelists agreed that having one more “tool in the Parkinson’s toolbox” is a win. More available treatments means more opportunities for customized care. 

What does “Advanced Parkinson’s” actually mean?

The FDA’s approval of VYALEV specifies that the treatment is for people with “advanced Parkinson’s,” a term with no consensus meaning, and one that can lead to intense feelings among those in the Parkinson’s community. The panelists spent some time sharing their thoughts about the phrase and what it means to them. Below are a few of highlights from the conversation 

• I hate the idea of someone being excluded from a treatment option that could help them because of a somewhat ambiguous term like “advanced Parkinson’s.” If you could benefit, you should be able to use it. 

• I think the definition of Parkinson’s is enough: it’s chronic and progressive. Adding the word “advanced” to it isn’t necessary. 

• If we put ourselves in a box, we start living in a box. I like having choices and trying hard to make the best choices in the moment, regardless of how long I’ve been living with Parkinson’s. 

• It seems like including the phrase “advanced Parkinson’s” in the approval is to allow insurance companies to determine who qualifies for coverage. 

• When it comes to chronic illnesses, so much is demanded to be black and white, especially in the insurance space. But there are so many nuances that are part of chronic illnesses. 

• If you think continuous infusion carbidopa/levodopa might be right for you, try not to care about what “advanced Parkinson’s” means. Focus on the experience you have with fluctuating motor symptoms, not the terminology of a stage you are, or are not, in. 

Finding the best treatment for you 

Whether it’s a new therapy or one that has been around for decades, the best treatment for you may take some time to determine. Keep paying attention to how your treatments make you feel, and keep speaking up about your care. If you feel like your needs aren’t being met, it may be worth exploring a different treatment with your care team. 

Advice for living well with Parkinson’s 

To wrap up the meetup, the panelists (and listeners) shared some of the best advice they’ve received about how to live well with Parkinson’s:

• Just like those of us with Parkinson’s, everyone is suffering in ways we cannot necessarily easily see. Show kindness to yourself and others. 

• Be ready for some surprises. You may think that you know what’ll happen with Parkinson’s, but you’re going to be surprised. 

• Learning to tolerate OFF moments is really important. We chase the ON moments, but your quality of life is directly proportional to the times you’re not free from Parkinson’s. You have to make some kind of peace with being OFF. 

• If you can do it safely, “practice” falling. I practiced falling a lot when I was early in my time with Parkinson’s because I figured I’m probably going to fall, and I need to learn how to fall safely. Try to become comfortable with the things you’re dealing with, and try to practice them to be able to deal with them more easily. 

• Meet yourself where you are in any moment. Don’t think about what you should do or should be able to do. Just live where you are in the moment without panicking or being frustrated about things that you think you should be able to do. 

• I got some very sage advice at a family wedding when I asked a 91-year-old with whom I was talking to at the bottom of a staircase for advice about living to 91. He said, “Use the handrails.” Now, that’s a really practical piece, but it speaks to a lot–slowing down, being in the moment, living with your Parkinson’s, practicing the OFF moments. 

• Michael J. Fox talking about vanity going out the window helped me. Vanity is the least of my concerns now. 

• I was riding my bike over the summer completing a 500-kilometer ride, and I had a fear of riding on gravel. I was near the back of the pack and another teammate was behind me and she said, “You’re going very slow.” I said, “Yes, I’ve got this fear of gravel.” She asked if she could give me some advice and I said sure, and she said, “Keep to your lane, go fast, and be confident.” I’ve kept that thought in my head every day since, because I’m equating that and internalizing that in my life with Parkinson’s. “Keep to your lane” means that we all experience Parkinson’s differently, but there’s community in numbers. “Go fast,” well, she meant to get through the gravel but to a certain extent, like we talked about it today, the progressive nature of Parkinson’s can seem fast. And confidence is very important. That is, we’ve got to be in control of our lives and our destiny to the extent that we can. 

• Exercise, exercise, exercise. It helps with motor symptoms and non-motor symptoms alike.  

• Hope for the best; plan for the worst. 

• If you’re dealing with balance problems, seek out a physical therapist who can help. 

• Be the “squeaky wheel” and keep speaking up about what you need. 

• Educate yourself so you can advocate for yourself. 

• Stay connected through programs like these webinars. 

ADDITIONAL RESOURCES 

First Continuous Infusion Levodopa System Approved in the United States: What You Need to Know About VYALEV  

A New Extended-Release Levodopa Formulation 

The Benefits of Duopa for People with Parkinson’s 

Parkinson’s Medication Guide 

Advanced Parkinson’s Resources 

A Conversation about Advanced Parkinson’s 

Insurance for People with Parkinson’s 

Formularies, Insurance, and Parkinson’s 

How to Reduce the Cost of your Parkinson’s Medications