Continuous subcutaneous foslevodopa/foscarbidopa infusion shows promise in phase 3 study

Continuous subcutaneous infusion of foslevodopa/foscarbidopa was safe and improved motor complications in patients with advanced Parkinson’s disease, according to data presented at the European Academy of Neurology Congress 2022.

“ABBV-951 (foslevodopa/foscarbidopa) is a solution of levodopa and carbidopa prodrugs for continuous subcutaneous infusion being investigated for the treatment of advanced Parkinson's disease in patients whose motor symptoms are not controlled by oral medications,” Jason Aldred, MD, FAAN, of Selkirk Neurology & Inland Northwest Research in Spokane, Wash., and principal study investigator, said in a statement provided to Healio.

Aldred and fellow researchers sought to determine whether ABBV-951, delivered as a 24-hour subcutaneous infusion to control motor fluctuations in patients with advanced PD, was safe and effective for up to 1 year in an outpatient setting.

The phase 3 open-label, single-arm study included 244 levodopa-responsive PD patients (59.8% men; 84.8% white; mean age, 64 years) with a minimum of 2.5 hours of “off” time per day. Assessments of efficacy included change from baseline in hours of both “on” and “off” time, along with presence of morning akinesia upon waking (reported through diary entries), activities of daily living (MDS-Unified Parkinson’s Disease Rating Scale Part II), sleep (Parkinson’s Disease Sleep Scale-2) and quality of life (Parkinson’s Disease Questionnaire-39, EQ-5D-5L).

Researchers observed improvements in motor complications as early as week 1, which persisted through week 52. In addition, at week 52, the mean increase in “on” time without troublesome dyskinesia was 3.58 hours, and the decrease in “off” time was 3.39 hours, suggesting ABBV-951 is a “potentially efficacious and a therapeutic option for advanced PD that doesn’t require surgery,” according to Aldred. Data further revealed the percentage of patients with morning akinesia decreased from 77.7% to 19.4%.

The most frequent adverse events included infusion site skin events, the majority of which were non-serious, mild to moderate in severity and resolved.

“Patients with advanced Parkinson’s disease need more therapeutic options to control their symptoms and troublesome dyskinesia for this debilitating disease,” Aldred said. “The data presented is promising.”