Continuous Subcutaneous Infusion of Levodopa/Carbidopa Has Long-Term Safety in Parkinson Disease

The phase 2b BeyoND study demonstrates the infusion of levodopa/carbidopa (ND0612; Neuroderm, Israel) was safe and well tolerated over a year long period in individuals with Parkinson disease (PD) with motor fluctuations. As reported in 2021, treatment with continuous subcutaneous infusion of levodopa/carbidopa improved good ON time by an adjusted mean of 2.3 hours at month 3 in a24-hour dosing regimen (n = 44) and 2.6 hours in a 16-hour dosing regimen (n = 83). The improvements were maintained over the 12-month study period.

Most participants who completed 1 year of treatment (95%) enrolled in the open-label extension study, and some continued treatment for up to 6 years. This subcutaneous infusion is minimally invasive.

"At this time, ND0612 is the only investigational subcutaneous, continuous levodopa/carbidopa treatment with safety data extending beyond one year," said Stuart Isaacson, MD, author of the BeyoND study long-term safety poster and associate professor of Neurology, FIU and director, PD and Movement Disorders Center of Boca Raton, Fla. "This latest data reinforces a positive long-term safety and tolerability profile of ND0612, indicating it has the potential to become a convenient and safe treatment option for those struggling with motor fluctuations in PD."

Treatment-emergent adverse events (TEAEs) observed in the study were generally mild to moderate, with infusion site reactions and nausea being most common. In the first year of treatment, 17.5% of participants discontinued use due an adverse event, 3.5% of which (n=4) were because of infusion site reactions.

"Motor fluctuations can greatly impact the quality of life of those living with PD, often driving patients to seek treatment beyond oral medications," said Dr. Laurence Salin, senior medical director of NeuroDerm. "For people with PD not adequately controlled by oral levodopa/carbidopa, we hope ND0612 can potentially offer a more reliable, sustained relief of motor fluctuations."

These data were presented at the American Academy of Neurology Annual Meeting held in Seattle, WA April 2-7 and virtually April 24-26.