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Produodopa® and Duodopa® (levodopa/carbidopa intestinal gel) were shown to have comparable levodopa Cmax, AUC, and degree of fluctuation, supporting a comparable efficacy profile1*
*In the PK Comparability Study, Produodopa® is administered as a continuous subcutaneous infusion, 24 hours per day. In healthy volunteers, steady state was achieved within 2 hours when Produodopa® was delivered as a loading dose followed by continuous infusion. Steady state was maintained during the infusion period.1
AUC=area under the curve; Cmax=peak concentration; LD/CD=levodopa/carbidopa; PK=pharmacokinetics.
Produodopa® provides stable levodopa plasma levels compared to oral IR levodopa/carbidopa dosing4
*To assess PK fluctuation differences, the average levodopa and carbidopa exposures following Produodopa® infusion were compared to simulated exposure of daily doses of 400/100 mg LD/CD TID.
IR=immediate release; LD/CD=levodopa/carbidopa; PD= Parkinson’s disease; PK= Pharmacokinetics; TID=three times a day.
What Does 24-Hour Continuous Delivery Without Surgery Mean for Your Patients?
Reduction in morning "Off" time (morning akinesia)2*
Fewer interruptions over 24 hours morning, day, and night2†
More "On" time and less "Off" time over 24 hours means patients can do more1‡
*As demonstrated by a reduction in the number of patients reporting morning “Off” (morning akinesia) in their PD Diaries from baseline to Week 12.2 Morning akinesia was defined as reporting “Off” status as the first morning symptom upon awakening.2
†In the clinical trials, patients recorded their PD symptoms in a PD Diary, which was completed for a full 24-hour period. Patients made an entry upon waking and every 30 minutes during their normal waking time. Patients recorded whether they were “On,” “Off,” or “Asleep” and what the severity of their dyskinesia (troublesome or not troublesome) was.2
‡More refers to “On” time compared to oral IR levodopa/carbidopa. Patients in the Produodopa® study experienced significant improvements compared with oral IR levodopa/carbidopa at Week 12, including “On” time without troublesome dyskinesia and “Off” time.1,2
IR=immediate-release; PD=Parkinson's disease.
WHY PRODUODOPA?
CLINICAL PROFILE
SAFETY
INITIATION & CUSTOMISATION
- Produodopa® (foslevodopa/foscarbidopa solution for infusion) Summary of Product Characteristics, available on www.medicines.ie.
- Soileau MJ, et al. Lancet Neurol. 2022; 21:1099–1109 (incl. suppl.).
- Rosebraugh M, Stodtmann S, Liu W, Facheris M. Parkinsonism Relat Disord. 2022;97:68–72
- Rosebraugh M, Liu W, Neenan M, Facheris MF. J Parkinsons Dis. 2021;11(4):1695–1702.
IE-PRODD-240012 Date of preparation: August 2024.
