Evaluating the effectiveness and safety of continuous subcutaneous foslevodopa-foscarbidopa for the treatment of motor fluctuations in patients with Parkinson’s disease.

This study evaluated the effectiveness and safety of continuous subcutaneous foslevodopa-foscarbidopa (ABBV-951) for the treatment of motor fluctuations in patients with Parkinson’s disease (PD). The data showed that continuous subcutaneous foslevodopa-foscarbidopa significantly improved motor fluctuations in these patients.

Parkinson’s disease (PD) is a chronic disorder that affects certain brain cells. This disease can cause movement symptoms such as tremors, muscle rigidity, and decreased balance. The standard treatment is levodopa alone or in combination with carbidopa. However, long-term levodopa-carbidopa is associated with negative side effects such as off-times and dyskinesia (abnormal body movements) impacting quality of life. Off-times consist of the period between levodopa doses when the PD symptoms come back, sometimes worse. Dyskinesia is the name used for involuntary movements of the body such as jerks and spasms and it can have a big impact on patients' quality of life.

Foslevodopa-foscarbidopa is a solution of levodopa and carbidopa prodrugs that is delivered as a 24-h/day continuous subcutaneous (under the skin) infusion. However, the effectiveness and safety of foslevodopa-foscarbidopa for the treatment of motor fluctuations in patients with PD are still unknown.

This study involved 141 patients with advanced PD. Patients were randomly assigned into two groups. Group 1 included 74 patients who received a continuous subcutaneous infusion of foslevodopa-foscarbidopa plus oral placebo capsules. Group 2 included 67 patients who received oral encapsulated immediate-release levodopa-carbidopa plus a continuous subcutaneous infusion of a placebo solution. The patients were followed up for 12 weeks.

Patients in group 1 showed a significantly greater increase in on-time without troublesome dyskinesia (2.72 hours) compared to patients in group 2 (0.97 hours). Patients in group 1 showed a significantly greater decrease in off-time (2.75 hours) compared to patients in group 2 (0.96 hours).

The rate of serious side effects was similar between the two groups (8% in group 1 vs. 6% in group 2). The most common side effects in group 1 were redness, swelling, pain in the infected area of the skin, and excess fluid retention.

This study concluded that continuous subcutaneous foslevodopa-foscarbidopa significantly improved motor fluctuations in patients with benefits in both on-time without troublesome dyskinesia and off-time in patients with advanced PD.

This study was funded by Abbvie, the manufacturer of foslevodopa-foscarbidopa.