A new soluble formulation of levodopa-cardiopa delivered via a continuous subcutaneous infusion (CSCI) and portable pump is showing promise as a treatment for advanced Parkinson’s disease.
A phase 3 RCT compared the safety and efficacy of 24-h/day foslevodopa-foscarbidopa with the oral immediate-release levodopa-carbidopa for the treatment of motor fluctuations in 145 patients with advanced Parkinson’s disease.
Patients were aged ≥30 years, on a minimum of 400 mg/day levodopa equivalents, and with inadequately controlled motor fluctuations with an average off time of at least 2·5 h/day over 3 consecutive days.
The study, conducted across 65 centres in the US and Australia, found foslevodopa-foscarbidopa provided a significant increase in on time without troublesome dyskinesia at week 12 compared with the oral levodopa–carbidopa (p=0·0083).
Similarly, in a key secondary outcome, treatment with foslevodopa-foscarbidopa showed a significant decrease in off time at week 12 compared with oral levodopa-carbidopa (p=0.0054).
“The improvements in on and off times were observed as early as the first post-baseline assessment and continued to the end of the double-blind treatment period at week 12,” the study said.
“On time without dyskinesia showed a 25% (3·96 [3·77] h) increase from baseline in the foslevodopa-foscarbidopa group compared with a 7% (1·15 [3·63] h) increase in the oral levodopa–carbidopa group as a percentage of the waking day.”
The study, published in The Lancet Neurology [link here], did not find a significant difference between groups in another key secondary endpoint of the Movement Disorder Society-Unified PD Rating Scale (MDS-UPDRS) part II score.
Regarding safety, the study found adverse events were more common with the continuous infusion (85% v 63%) but most were mild or moderate in severity. They included infusion site reactions (72% v 12%) which were typically erythema, pain, cellulitis and oedema.
Hallucinations or psychosis were more common with foslevodopa-foscarbidopa (15% v 3%) while falls and associated injuries were less common (18% v 25%).