The October Living with Parkinson’s Webinar Meetup focuses on discussion of two news items: an update about the phase 3 trial of exenatide and the United States Food and Drug Administration’s approval of the first continuous infusion carbidopa/levodopa system for treatment of motor fluctuations associated with advanced Parkinson’s. 

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 car