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Irish Reimbursement Granted to PRODUODOPA® (foslevodopa/foscarbidopa) for People Living with Advanced Parkinson’s Disease

AbbVie has announced that the Irish health authorities have approved reimbursement of PRODUODOPA® (foslevodopa/foscarbidopa) for the treatment of advanced levodopa-responsive Parkinson’s disease with severe motor fluctuations and hyperkinesia (excessive movement) or dyskinesia (involuntary movement) when available combinations of Parkinson medicinal products have not given satisfactory results.[i]

This follows granting of the product authorisation for PRODUODOPA® (foslevodopa/foscarbidopa) in Ireland on 23 September 2022. 1 It is a subcutaneous 24-hour infusion of levodopa-based therapy for the treatment of severe motor fluctuations in people living with advanced Parkinson’s disease whose symptoms are inadequately controlled by other therapies.1 The continuous delivery of foslevodopa/foscarbidopa provides levodopa 24-hours a day which may help patients by extending the period when symptoms are well-controlled, often referred to as “On” time.[ii] The VYAFUSER™ pump for the subcutaneous delivery of PRODUODOPA® received Conformité Européenne (CE) Mark in November 2023.

Parkinson’s disease is a chronic, progressive neurodegenerative disorder affecting approximately 6.1 million people globally[iii]. Parkinson’s disease is characterised by tremor, muscle rigidity, slowness of movement and difficulty with balance.[iv] As the disease progresses, the severity of symptoms increases[v], and patients tend to experience greater disability and an impaired ability to perform activities of daily living[vi], as well as the reemergence of symptoms as standard treatment wears off.[vii] Characteristics of advanced Parkinson’s disease may include needing help with performing daily activities, increased motor fluctuations (changes in the ability to move referred to as “On-Off” times), difficulty swallowing, recurrent falls, dementia, dyskinesia (involuntary movements) and other symptoms.5

“People living with Parkinson’s disease experience daily challenges and uncertainty, especially as their disease progresses and symptoms are no longer adequately controlled” said Andres Rodrigo, General Manager of AbbVie in Ireland.7,[viii],[ix],[x] “I welcome the availability of foslevodopa/foscarbidopa for the therapeutic management of Parkinson’s disease in indicated patients.”

Three Studies

The authorisation was supported by three studies: the Phase 3, 12-month open label study (M15-741 study) which evaluated the long-term safety, tolerability, and efficacy of continuous subcutaneous infusion of foslevodopa/foscarbidopa [xi], the Phase 3, 12-week study (M15-736 study) which compared the efficacy and safety of foslevodopa/foscarbidopa to oral levodopa/carbidopa2, and a Phase 1 pharmacokinetic comparability study.[xii]

The most frequent adverse reactions (greater than or equal to 10 percent) were infusion site events (infusion site erythema, infusion site cellulitis, infusion site nodule, infusion site pain, infusion site oedema, infusion site reaction, and infusion site infection), hallucination, fall, and anxiety. The majority of infusion site events were non-serious, mild or moderate in severity and resolved spontaneously or with treatment.1

About the Phase 3 M15-741 Study11

The Phase 3, single arm, open-label study evaluated the safety and tolerability, and efficacy of 24-hour daily exposure of continuous subcutaneous infusion of foslevodopa/foscarbidopa in people with advanced Parkinson’s disease whose motor symptoms were inadequately controlled by their current treatment. The primary endpoint was to evaluate the safety and tolerability of foslevodopa/foscarbidopa. Secondary endpoints included changes from baseline in normalised “Off” and “On” time, percentage of patients reporting morning akinesia, and total scores from quality-of-life surveys. The study was conducted at 58 sites across 13 countries (Australia, Belgium, Canada, Denmark, Germany, Italy, Japan, Netherlands, Russia, Spain, Sweden, United Kingdom, and United States). Eligible patients included adults 30 years or older diagnosed with levodopa-responsive idiopathic Parkinson’s disease experiencing an average of greater than or equal to 2.5 hours of “Off” time per day, as assessed by patient’s Parkinson’s disease diaries. Infusion site events were the most common adverse events (AEs). AEs were mostly nonserious (25.8% of patients reported serious AEs) and mild/moderate in severity. Reduction in motor fluctuations was observed as early as one week and persisted through week 52. The percentage of patients experiencing morning akinesia dropped from 77.7 percent at baseline to 27.8 percent at week 52. Indicators of sleep and quality of life were assessed from baseline through week 52 as published in the Journal of Neurology & Therapy ( More information on the study can be found on (NCT03781167).

About the Phase 3 M15-736 Study2

The Phase 3 randomised, double-blind, double-dummy, active-controlled study compared the efficacy, safety, and tolerability of foslevodopa/foscarbidopa to oral immediate-release levodopa/carbidopa (LD/CD) in patients with advanced Parkinson’s disease. Participants were provided with a home diary (the PD Diary) to assess their motor state during the day. The primary endpoint was “On” time without troublesome dyskinesia. The study included 141 participants who were randomly assigned and received treatment at 65 centers in the U.S. and Australia. Participants were randomized one to one to receive either the foslevodopa/foscarbidopa solution as a continuous delivery under the skin (subcutaneous) plus oral placebo capsules for LD/CD or oral capsules containing immediate-release LD/CD plus continuous subcutaneous delivery of placebo solution for foslevodopa/foscarbidopa. The treatment duration was 12 weeks. The increase in “On” time without troublesome dyskinesia at week 12 was an average of 2.72 hours for foslevodopa/foscarbidopa versus 0.97 hours for oral LD/CD (p= 0.0083). Improvements in “On” time were observed as early as the first week and persisted throughout the 12 weeks. This study also assessed changes from baseline to week 12 in motor experiences of daily living, morning akinesia, sleep, and quality of life indicators, however results did not achieve statistical significance. More information on the study can be found on (NCT04380142) and in The Lancet Neurology (

About the Phase 1 Pharmacokinetic study12

A Phase 1, open label, randomized, two period cross over study was conducted to compare the pharmacokinetics (PK) of levodopa from 24-hour continuous subcutaneous infusion of foslevodopa/foscarbidopa to the PK of levodopa from 16-hour levodopa-carbidopa intestinal gel (LCIG), followed by two night-time oral levodopa/carbidopa (LD/CD) doses. The levodopa exposures following subcutaneous infusion of foslevodopa/foscarbidopa over 24 hours were similar (less than 8 percent difference) to those of LCIG administered over 16 hours, followed by two oral doses at 18 and 21 hours after the start of LCIG delivery. The study concluded that 24-hour continuous subcutaneous infusion of foslevodopa/foscarbidopa provides levodopa exposures comparable to LCIG throughout the day. More information on the study can be found in Parkinsonism & Related Disorders


The full Summary of Product Characteristics (SmPC) for Produodopa® is available at

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