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
The primary endpoint was change from baseline to Week 12 in average daily normalised ‘ON’ time without troublesome dyskinesia
Pivotal Phase 3, randomised, double-blind, double-dummy, active-controlled study conducted at 65 academic and community study centres in the USA and Australia, evaluating the efficacy and safety of 24-hour daily continuous subcutaneous infusion of PRODUODOPA compared with oral IR levodopa/carbidopa in patients with advanced PD.
The study included a STABILISATION PERIOD of 14–21 days prior to randomisation
Primary endpoint:
- Change from baseline to Week 12 in average daily normalised ‘ON’ time without troublesome dyskinesia*
*’ON’ time without troublesome dyskinesia is the sum of normalised ‘ON’ time without dyskinesia and normalised ‘ON’ time with non-troublesome dyskinesia. Daily ‘ON’ times were assessed using a 24-hour PD Diary and normalised to a 16-hour waking day.
Key secondary endpoints (tested in hierarchical order):
Hierarchical testing for significance was terminated at the first secondary endpoint, change in MDS-UPDRS Part II, as this did not reach statistical significance. As the secondary endpoints that followed MDSUPDRS Part II weren’t tested for significance, no clinical conclusions can be drawn from them.
- Change from baseline to Week 12 in average daily normalised ‘OFF’ time
- Change from baseline to Week 12 in MDS-UPDRS part II score
- Presence of morning akinesia at Week 12
Other secondary endpoints:
Change from baseline to Week 12 in average daily normalised ‘ON’ time without dyskinesia, change from baseline to Week 12 in PDSS-2 total score, PDQ-39 summary index, EQ-5D-5L summary index, median bradykinesia scores, median dyskinesia scores, IQR PKG bradykinesia scores and IQR PKG dyskinesia scores.
- ≥30 years of age with levodopa-responsive idiopathic PD
- Total daily dose of levodopa equivalents from levodopa-containing medications and COMT inhibitors ≥400 mg/day
- Inadequately controlled motor fluctuations (>2.5 h/day of ‘OFF’ time over three consecutive days)
- Male or female patients over the age of 30
- Recognisable/identifiable ‘OFF’ and ‘ON’ states (motor fluctuations)
- Normal cognitive function (MMSE score ≥24)
- 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
- History of DBS or LCIG
- Other continuous daily infusion of PD medication
- Previous exposure to PRODUODOPA
COMT=catechol-O-methyl transferase; CSCI=continuous subcutaneous infusion; D=day; DBS=deep brain stimulation; EQ-5D-5L=EuroQol 5-Dimension Questionnaire; IQR=interquartile range; IR=immediate release; LCIG=levodopa-carbidopa intestinal gel; LD/CD=levodopa/carbidopa; MDS-UPDRS=Movement Disorder Society-Unified Parkinson’s Disease Rating Scale; MMA=methylmalonic acid; MMSE=Mini-Mental State Examination; PD=Parkinson’s disease; PDSS-2=Parkinson’s Disease Sleep Scale-2; PDQ-39=39-item Parkinson’s Disease Questionnaire; PKG=Parkinson’s KinetiGraph or Personal KinetiGraph; V=visit; W=week.
1. PRODUODOPA (foslevodopa/foscarbidopa solution for infusion) UK Summary of Product Characteristics.
2. Solieau MJ, et al. Lancet Neurol. 2022;21:1099–109.
By clicking the link above you will leave the AbbVie Pro website and be taken to the eMC PI portal website
UK-PRODD-260289. Date of preparation: August 2026
Eligible advanced PD patients may experience more ‘ON’ time (p=0.0083) and less ‘OFF’ time (p=0.0054) vs oral IR LD/CD at 12 weeks2
LS mean change from BL to Week 12 in normalised ‘ON’ time without troublesome dyskinesia
PRODUODOPA treatment resulted in significant increase in ‘ON’ time without troublesome dyskinesia vs oral LD/CD as early as the first week and persisted throughout the 12 weeks of the study (p=0.0083)
’ON’ time without troublesome dyskinesia is the sum of ‘ON’ time without dyskinesia and ‘ON’ time with non-troublesome dyskinesia. Assessed using a 24-hour PD Diary and normalised to a 16-hour waking day. At baseline, the mean daily normalised ‘ON’ time without troublesome dyskinesia for patients on PRODUODOPA was 9.20 hours (SE 2.42) and 9.49 hours (SE 2.62) for patients taking optimised oral IR LD/CD.
Adapted from Soileau MJ, et al. 2022
LS mean change from baseline to Week 12 in normalised ‘OFF’ time2
PRODUODOPA treatment resulted in significant decrease in ‘OFF’ time vs oral LD/CD as early as the first week and persisted until the end of the study (p=0.0054)
At baseline, the mean daily normalised ‘OFF’ time for patients on PRODUODOPA was 6.34 hours (SE 2.27) and 5.91 hours (SE 1.88) for patients taking optimised oral IR LD/CD.
Adapted from Soileau MJ, et al. 2022
Infusion site events
- In the Phase 3 studies, the most common AEs related to PRODUODOPA were infusion site reactions 77.6% (n=294) and infusion site infections 41.4% (n=157)
- Infusion site events including infusion site reactions and infections, commonly seen with subcutaneous infusions were observed with PRODUODOPA in the clinical studies
- The majority of infusion site events were non-serious, were mild or moderate in severity, and resolved spontaneously or with treatment such as antibiotics and/or incision and drainage
- Three subjects with infusion site infections had a complication of sepsis resulting in hospitalisation
- Monitor for any skin changes at the infusion site that could indicate a potential infection, such as redness associated with warmth, swelling, pain, and discolouration when you apply pressure to it
- Aseptic techniques should be followed while using this medication and consider rotating the infusion site more frequently than every 3rd day, using a new infusion set if you see these skin changes. It is recommended that new infusion sites be at least 2.5 cm from sites used within the previous 12 days
BL=baseline; CI=confidence interval; IR=immediate release; LD/CD=levodopa/carbidopa; LS=least squares; PD=Parkinson’s disease; SE=standard error.
1. PRODUODOPA (foslevodopa/foscarbidopa solution for infusion) UK Summary of Product Characteristics.
2. Solieau MJ, et al. Lancet Neurol. 2022;21:1099–109.
By clicking the link above you will leave the AbbVie Pro website and be taken to the eMC PI portal website
UK-PRODD-260289. Date of preparation: August 2026
The safety profile observed in this Phase 3 trial was consistent with other studies of PRODUODOPA and there were no new significant safety concerns2
PRODUODOPA was generally well tolerated with the majority of adverse events including infusion site AEs reported as non-serious and mild or moderate in severity2
Overview of treatment-emergent AEs (safety analysis set)2
| At 12 weeks, n (%) | PRODUODOPA (n=74) | Oral LD/CD (n=67) |
| Adverse events | 63 (85%) | 42 (63%) |
| Deaths | 0 | 1 (1%) |
| Serious adverse events | 6 (8%) | 4 (6%) |
| Severe adverse events | 7 (9%) | 1 (1%) |
| Any adverse event leading to death | 0 | 1 (1%)* |
| Any adverse event leading to premature study drug discontinuation† | 16 (22%) | 1 (1%) |
| Any adverse event considered related to study drug | 52 (70%) | 15 (22%) |
Figure adapted from Soileau MJ, et al. 2022.
Preferred terms classified according to the Medical Dictionary for Regulatory Activities version 24.0.
*Considered by the investigator to have no reasonable possibility of being related to study drug.
†Adverse events were one of the reasons for discontinuation, irrespective of whether it was the primary reason.
Primary reasons for drug discontinuation in both groups were adverse events, withdrawn consent, and difficulty with the drug delivery system. The incidence of adverse events leading to study drug discontinuation was higher in the PRODUODOPA group with infusion site adverse events (cellulitis 4/74 [5%]), pain (3/75 [4%]), bruising, haemorrhage and oedema (2/74 [3%]) being most common.
AEs of special interest2
- AEs of special interest were as expected given the patient population, drug class and route of administration2
- The incidence of AEs leading to study drug discontinuation was higher in the PRODUODOPA group with infusion site adverse events (cellulitis four [5%] of 74), pain (three [4%] of 74), bruising (two [3%] of 74), haemorrhage (two [3%] of 74), and oedema (two [3%] of 74) being most common2*
| At 12 weeks, n (%) | PRODUODOPA (n=74) | Oral LD/CD (n=67) |
| Infusion site events | 53 (72%) | 8 (12%) |
| Hallucinations or psychosis | 11 (15%) | 2 (3%) |
| Falls and associated injuries | 13 (18%) | 17 (25%) |
| Somnolence | 1 (1%) | 1 (1%) |
| Polyneuropathy | 2 (3%) | 2 (3%) |
| Weight loss | 1 (1%) | 1 (1%) |
*Most discontinuations occurred within the first four weeks following treatment initiation. These early discontinuations probably coincide with a period of familiarisation with the drug-delivery system, reinforcing the importance for HCPs and patients to be well trained on the proper administration of PRODUODOPA. Figure adapted from
Soileau MJ, et al. 2022.
Most frequent (≥5%) AEs2
| At 12 weeks, n (%) | PRODUODOPA (n=74) | Oral LD/CD (n=67) |
| Infusion site erythema | 20 (27%) | 1 (1%) |
| Infusion site pain | 19 (26%) | 1 (1%) |
| Infusion site cellulitis | 14 (19%) | 0 |
| Infusion site oedema | 9 (12%) | 0 |
| Dyskinesia | 8 (11%) | 4 (6%) |
| Fall | 6 (8%) | 12 (18%) |
| Infusion site bruising | 6 (8%) | 2 (3%) |
| Infusion site haemorrhage | 6 (8%) | 0 |
| Infusion site nodule | 6 (8%) | 0 |
| ‘ON’ and ‘OFF’ phenomena | 6 (8%) | 0 |
| Hallucination | 5 (7%) | 1 (1%) |
| Balance disorder | 4 (5%) | 0 |
| Constipation | 4 (5%) | 0 |
| Hallucination visual | 4 (5%) | 0 |
| Infusion site induration | 4 (5%) | 0 |
| Infusion site infection | 4 (5%) | 0 |
| Infusion site pruritus | 4 (5%) | 0 |
| Peripheral swelling | 4 (5%) | 0 |
Figure adapted from Soileau MJ, et al. 2022.
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. Solieau MJ, et al. Lancet Neurol. 2022;21:1099–109.
By clicking the link above you will leave the AbbVie Pro website and be taken to the eMC PI portal website
UK-PRODD-260289. Date of preparation: August 2026
