Foslevodopa/Foscarbidopa Injection for Advanced PD Leads to Greater Benefits

Patients with advanced Parkinson disease (PD) experience improved time with symptom control when receiving subcutaneous foslevodopa/foscarbidopa (LDP/CDP) compared with oral levodopa/carbidopa (LD/CD), according to study results presented at the 2024 American Academy of Neurology (AAN) annual meeting, held from April 13 to 18, 2024, in Denver, Colorado.

While oral LD/CD is a treatment option for PD, motor dyskinesias and fluctuations have continued to be difficult to control with disease progression. Researchers developed LDP/CDP, which is a soluble combination of LD/CD prodrugs administered subcutaneously as a continuous 24-hour-a-day infusion.

In the phase 3 study of this medication, when compared with oral LD/CD, LDP/CDP showed a significant increase in “on” time and a decrease in “off” time. “On” time is the time on the medication when patients experience good symptom control; “off” time is when symptoms return between medication doses. 

In the present study, researchers conducted a subgroup analysis of a phase 3, randomized, double-blind, active-controlled study (ClinicalTrials.gov Identifier: NCT04380142). The study population included patients with advanced PD who were administered LDP/CDP or oral LD/CD for 12 weeks.

The analysis was conducted in different patient subgroups, including age groups (<65 or ≥65), sex, race (White or other), country (United States or Australia), duration of PD (<10 or ≥10 years), and dopamine agonist use. In these subgroups, researchers evaluated “on” time without dyskinesia, “on” time without troublesome dyskinesia, and “off time” and compared the changes from baseline to the final follow-up.

A total of 139 patients were included in the study, with 73 patients receiving LDP/CDP and 66 assigned to oral LD/CD. 

The analysis revealed that patients younger than age 65 who received LDP/CDP vs those on oral LD/CD showed significant increases in “on” time without troublesome dyskinesia from baseline to final visit (least squares mean [LSM], 3.5 hours; standard error [SE], 0.7 hours vs LSM, 0.5 hours; SE, 0.7 hours; P =.003). Patients aged 65 and older demonstrated improvements in “on” time without troublesome dyskinesia (LSM, 1.7; SE, 0.5 hours vs LSM, 1.0 hours; SE, 0.5 hours). 

Additionally, all other subgroup analyses showed that patients assigned to the LDP/CDP group vs those on oral LD/CD had increased numerical improvements in “on” time without dyskinesia, “on” time without troublesome dyskinesia, and “off” time. The treatment effect between subgroups showed no significant differences. 

“Patients experienced greater benefits with LDP/CDP vs oral LD/CD across all subgroups,” the researchers concluded.

Disclosure: Some study authors declared affiliations with biotech, pharmaceutical, and/or device companies. Please see the original reference for a full list of authors’ disclosures.