Over 50% of PD patients experience motor complications (OFF, dyskinesia or both) within five years of starting levodopa and up to 100% by ten years. This creates a significant burden because OFF and dyskinesia affect patients’ function and ability to perform basic tasks such as walking, dressing, eating, balance, participating in hobbies, and communicating. OFF and dyskinesia can be socially isolating, affecting social interactions and emotional well-being. In fact, motor complications were cited as the top symptoms affecting quality of life in a survey of patients who have had Parkinson’s disease for at least six years. At American Academy of Neurology 2021 Meeting, Jill Farmer, D.O., M.P.H., Assistant Professor of Neurology at Drexel College of Medicine and Director of Parkinson’s Disease and Movement Disorder Program at Global Neuroscience Institute, presented the results of a telling survey: The survey, co-sponsored by PMD Alliance and Adamas, was based on 775 respondents, including 527 people with Parkinson’s and 248 care partners. It showed that PD motor complications are common with 76% (n=591) of respondents reporting OFF and 51% (n=398) reporting dyskinesia; 48% (n=368) of respondents reported experiencing both OFF and dyskinesia. For respondents who experience motor complications, they happen often. Between 86% and 90% reported the presence of these problems daily and over 60% of respondents changed plans and activities due to these PD motor complications. Ultimately, for many respondents, PD motor complications were found to be unpredictable, make social interactions difficult, and lead to feelings of embarrassment, loneliness and isolation.
Approximately 80% of people with dyskinesia also experience OFF, and it can be a delicate balance to address the symptoms of Parkinson’s OFF time with enough levodopa without triggering dyskinesia that happens as a result of high levels of levodopa medication. Traditionally, treating OFF or dyskinesia required addressing one or the other in isolation. The only option for the treatment of both combined until now had been deep brain stimulation, an invasive surgical procedure involving implantation of electrodes in the brain. Now, however, patients and physicians have another option with GOCOVRI, as the first medication approved to reduce both – in a once –a-day pill taken at bedtime, which provides all day coverage upon waking up the next morning. GOCOVRI is an example of an innovative approach to provide clinically meaningful benefits to patients.
GOCOVRI’s dual FDA approvals were based on data from two pivotal, placebo-controlled Phase 3 clinical studies that showed treatment with GOCOVRI more than doubled the daily time patients spent in good ON time (ON time without any dyskinesia) from 3.9 hours a day at baseline to 8.4 hours at Week 12. Compared to placebo, those treated with GOCOVRI experienced an additional 2.9 hours ON time (good movement control) without dyskinesia, an increase driven by a reduction in both OFF time and dyskinesia. Additionally, sustained efficacy of GOCOVRI for at least two years was observed in the Phase 3, open-label EASE LID-2 study.
In addition to the physical, social and emotional impacts of OFF and dyskinesia, there are economic burdens associated with the progression of these PD motor complications, including time lost, decreased patient utility during episodes of OFF and dyskinesia, and additional healthcare costs. Motor complications also increase the burden placed on caregivers as well. GOCOVRI, as the first and only FDA approved treatment for OFF and dyskinesia, can play an important role in the reduction of these burdens. Now, patients don’t have to “trade-off”, treating one motor complication at the expense of having to live with the other. In studies GOCOVRI has been shown to increase Good ON time, which is the primary goal for the treatment of PD motor complications, by 2.4 hours a day. This may enable people with Parkinsons to continue in their careers or remain independent for longer.