This promotional material is intended for UK Healthcare Professionals (HCPs) experienced in the diagnosis and management of Parkinson’s disease only. Adverse event reporting can be found below
PRODUODOPA is indicated for the treatment of advanced levodopa-responsive Parkinson’s disease with severe motor fluctuations and hyperkinesia or dyskinesia when available combinations of Parkinson’s medicinal products have not given satisfactory results.1
In the 52-week safety study the primary endpoint was to establish safety and tolerability across 52 weeks
Phase 3, single-arm, open-label study conducted at 60 sites across 13 countries, evaluating the safety, tolerability, and efficacy of 24-hour daily exposure with a continuous subcutaneous infusion of PRODUODOPA in patients with advanced PD.
*The 6-day monitoring period can occur at any time during the screening period. During the monitoring period, PD diaries are collected for a minimum of two consecutive days.
Adapted from Aldred J, et al. 2023.
*The 6-day monitoring period can occur at any time during the screening period. During the monitoring period, PD diaries are collected for a minimum of two consecutive days.
Adapted from Aldred J, et al. 2023.
Following a monitoring phase of 6 days*,
244 patients began treatment with PRODUODOPA:
The primary endpoints were safety and tolerability:
The proportion of patients reporting adverse events, changes in laboratory parameters, vital sign measurements, and electrocardiogram values from baseline. Local skin tolerability was additionally assessed by the Infusion Site evaluation scale.
Secondary endpoints:
Change from baseline in the average daily normalised ‘OFF’ time and ‘ON’ time as assessed by the PD diary and normalised to a 16-hour waking day, MDSUPDRS Parts I–IV (with Part III measured in the patient’s best ‘ON’ state), PDSS-2, PDQ-39, EQ-5D-5L and the proportion of patients with morning akinesia.
- ≥30 years of age with levodopa-responsive idiopathic PD
- Symptoms inadequately controlled by current stable therapy
- Recognisable ‘ON’ and ‘OFF’ states
- Minimum daily average of ≥2.5 hours of ‘OFF’ time
- Low vitamin B12 level (<200 pg/mL) or low-normal vitamin B12 level (<300 pg/mL) with elevated MMA (>0.41 μmol/L) at V1
- History of significant skin conditions or disorders
CSCI=continuous subcutaneous infusion; D=day; EQ-5D-5L=EuroQol 5-Dimension Questionnaire; MDSUPDRS=Movement Disorder Society-Unified Parkinson’s Disease Rating Scale; MMA=methylmalonic acid; PD=Parkinson’s disease; PDSS-2=Parkinson’s Disease Sleep Scale-2; PDQ-39=39-item Parkinson’s Disease Questionnaire; V=visit; W=week.
1. PRODUODOPA (foslevodopa/foscarbidopa solution for infusion) UK Summary of Product Characteristics.
2. Aldred J, et al. Neurol Ther. 2023;12:1937–58.
By clicking the link above you will leave the AbbVie Pro website and be taken to the eMC PI portal website
UK-PRODD-260291. Date of preparation: August 2026
PRODUODOPA was generally well-tolerated up to 52 weeks in the long-term, Phase 3 open-label study2
94% of patients experienced at least one AE. Most were non-serious, mild and moderate in severity, and typically resolved with or without treatment12
Overview of treatment-emergent AEs (safety analysis set)2
| Adverse events, n (%) | PRODUODOPA (N=244) |
| AEs | 230 (94.3%) |
| AEs associated with study drug | 224 (91.8%) |
| Severe AEs* | 63 (25.8%) |
| SAEs* | 63 (25.8%) |
| AEs leading to discontinuation of study drug | 64 (26.2%) |
| Deaths†‡ | 3 (1.2%) |
Figure adapted from Aldred J, et al. 2023.
Preferred terms classified using the Medical Dictionary for Regulatory Activities, version 24.0.
*While the values for severe AEs and SAEs were the same, the patients reporting these events were not the same for each event.
†There were a total of five deaths in the safety population; two were non-treatment-emergent (did not occur during study treatment or within 30 days of the last PRODUODOPA infusion); all were determined by investigators to be unrelated to the study drug.
‡Treatment-emergent deaths include subdural hematoma (most likely related to traumatic injury from an accidental fall) and cerebral mass effect, cardiorespiratory arrest, and cerebrovascular accident.
AEs of special interest (safety analysis set)2
- Median time to onset for ISRs was 8.0 days and most resolved with a median duration of 12.0 days2
- Median time to onset for IS-related infections was 43.5 days, and most resolved with a median duration of 15.5 days2
| Safety events, n (%) | PRODUODOPA (N=244) |
| Infusion site reactions | 200 (82.0%) |
| Infusion site–related infections | 86 (35.2%) |
| Falls and associated injuries | 74 (30.3%) |
| Hallucinations/psychosis | 61 (25.0%) |
| Weight loss | 27 (11.1%) |
| Somnolence | 12 (4.9%) |
| Polyneuropathy (narrow SMQ) | 8 (3.3%) |
Figure adapted from Aldred J, et al. 2023.
Preferred terms classified using the SMQ.
Most frequent (≥10%) AEs2
The most common AEs were infusion site AEs (erythema [52.0%], nodule [28.7%], cellulitis [23.0%], edema [19.3%], pain [15.6%], reaction [12.3%], and abscess [11.1%]), followed by hallucination (17.2%), and fall (16.8%).2
| Adverse events, n (%) | PRODUODOPA (N=244) |
| Infusion site erythema | 127 (52.0%) |
| Infusion site nodule | 70 (28.7%) |
| Infusion site cellulitis | 56 (23.0%) |
| Infusion site oedema | 47 (19.3%) |
| Hallucination | 42 (17.2%) |
| Fall | 41 (16.8%) |
| Infusion site pain | 38 (15.6%) |
| Infusion site reaction | 30 (12.3%) |
| Anxiety | 29 (11.9%) |
| Infusion site abscess | 27 (11.1%) |
| Dizziness | 25 (10.2%) |
Figure adapted from Aldred J, et al. 2023.
SAEs occurring in >2 patients2
Infusion site cellulitis (n=10, 4.1%) and infusion site abscess (n=8, 3.3%) were the most common SAEs2
| Adverse events, n (%) | PRODUODOPA (N=244) |
| Infusion site cellulitis | 10 (4.1%) |
| Infusion site abscess | 8 (3.3%) |
| Hallucination | 7 (2.9%) |
| Parkinson’s disease | 6 (2.5%) |
| Psychotic disorder | 6 (2.5%) |
| Urinary tract infection | 4 (1.6%) |
| Sepsis | 3 (1.2%) |
| Pneumonia | 3 (1.2%) |
Figure adapted from Aldred J, et al. 2023.
AE=adverse event; HCP=healthcare professional; LD/CD=levodopa/carbidopa; SC=subcutaneous.
1. PRODUODOPA (foslevodopa/foscarbidopa solution for infusion) UK Summary of Product Characteristics.
2. Aldred J, et al. Neurol Ther. 2023;12:1937–58.
By clicking the link above you will leave the AbbVie Pro website and be taken to the eMC PI portal website
UK-PRODD-260291. Date of preparation: August 2026
Mean change from baseline to Week 52 in daily normalised ‘Off’ and ‘On’ time
Efficacy endpoints were summarised using descriptive statistics. P values throughout this study are nominal and therefore no clinical conclusions can be drawn from this data.2
Average daily normalised ‘Off’ time and ‘On’ time
*p<0.05, **p<0.01, ***p≤0.001, calculated using a two-sided paired-sample t test
Adapted from Aldred J, et al. 2023
Average daily normalised ‘Off’ time and ‘On’ time
*p<0.05, **p<0.01, ***p≤0.001, calculated using a two-sided paired-sample t test
Adapted from Aldred J, et al. 2023
The mean daily normalised ‘Off’ time for patients on PRODUODOPA was 5.9 hours (SD 2.2) at baseline.
The mean daily normalised ‘On’ time without dyskinesia was 6.5 hours (SD 3.4) at baseline.
The mean daily normalised ‘On’ time with non-troublesome dyskinesia was 2.6 hours (SD 2.6) at baseline.
The mean daily normalised ‘On’ time with troublesome dyskinesia was 1.0 hours (SD 1.7) at baseline.
The mean daily normalised ‘On’ time without troublesome dyskinesia was 9.1 hours (SD 2.5) at baseline.
CI=confidence interval; EQ-5D-5L=EuroQol 5-Dimension Questionnaire; IR=immediate release; LD/CD=levodopa/carbidopa; LS=least squares; MDS-UPDRS=Movement Disorder Society-Unified Parkinson’s Disease Rating Scale; PDQ-39=39-Item Parkinson’s Disease Questionnaire; PD=Parkinson’s disease; PDSS-2=Parkinson’s Disease Sleep Scale-2; SD=standard deviation; SE=standard error; SMQ=Standardized Medical Dictionary for Regulatory Activities query.
1. PRODUODOPA (foslevodopa/foscarbidopa solution for infusion) UK Summary of Product Characteristics.
2. Aldred J, et al. Neurol Ther. 2023;12:1937–58.
By clicking the link above you will leave the AbbVie Pro website and be taken to the eMC PI portal website
UK-PRODD-260291. Date of preparation: August 2026
