Continuous subcutaneous foslevodopa/foscarbidopa improved PD symptoms at 1 year
Click Here to Manage Email Alerts
Key takeaways:
- The phase 3 study included 244 patients with Parkinson’s disease given 24-hour subcutaneous infusion of foslevodopa/foscarbidopa.
- At 52 weeks, treatment significantly improved ‘on’ time and reduced ‘off’ time.
Continuous subcutaneous infusion of foslevodopa/foscarbidopa improved “on” time and reduced “off” time in those with Parkinson’s disease at 52 weeks, with a favorable safety and tolerability profile, per research from Neurology and Therapy.
“We were able to look at people with Parkinson’s disease who were taking oral levodopa with bothersome ‘off’ time and needed to consider some other option,” Jason Aldred, MD, FAAN, a neurologist at Selkirk Neurology PLLC, told Healio in an email. “This is the longest study to date of this formulation and we learned a great deal about how to make this potential treatment successful.”
The efficacy and safety of foslevodopa/foscarbidopa compared with oral immediate-release levodopa/carbidopa was previously demonstrated in PD through a 12-week, randomized, double-blind, phase 3 trial. Aldred and colleagues carried out a separate 52-week, open-label, phase 3 registrational trial evaluating the safety, tolerability and efficacy of 24-hour continuous subcutaneous infusion of foslevodopa/foscarbidopa in those with advanced PD.
Their trial was conducted at 60 sites across 13 countries and initially enrolled 244 individuals aged 30 years and older with levodopa-responsive PD andat least 2.5 hours of “off” time per day. Patients received their infusions at individually optimized therapeutic doses (approximately 700 mg to 4,250 mg) for 1 year. A total of 137 enrollees continued treatment and 107 discontinued. Dosing was initiated on day 1 with follow-up visits scheduled for day 2 and weeks 1 to 4, 6, 13, 26, 39 and 52.
Secondary endpoints included changes from baseline in normalized “off” and “on” time, percentage of patients reporting morning akinesia and changes in scores on the Movement Disorder Society Unified Parkinson’s Disease Rating Scale (MDS-UPDRS), Parkinson’s Disease Sleep Scale–2 (PDSS-2), 39-item Parkinson’s Disease Questionnaire (PDQ-39) and EuroQol 5-dimension questionnaire (EQ-5D-5L).
According to results, at week 52, “on” time without troublesome dyskinesia and “off” time were improved from baseline (mean change in normalized “on” time without troublesome dyskinesia, 3.8 [3.3] hours; normalized ‘off’ time, 3.5 [3.1] hours).
The percentage of patients experiencing morning akinesia dropped from 77.7% at baseline to 27.8% at week 52, with measurable improvements in both sleep quality (PDSS-2) and quality of life (PDQ-39 and EQ-5D-5L).
Data additionally showed infusion site events were the most common adverse events, with 25.8% of patients reporting serious AEs.
“We found that most patients successfully received 24 hours of subcutaneous infusion of foslevodopa at a single site anywhere from 1 to three days and that this was well tolerated,” Aldred told Healio. “Infusion site reactions did occur but most of these patients went on to continue with the study for the full 52 weeks.”
Editor’s note: This story was changed on Sept. 3, 2023, to update Dr. Aldred’s affiliation.