A pharmacokinetic* (PK) study aimed to serve as basis for an application for marketing authorization for Infudopa IntraV™ and Infudopa SubC™ was completed in April 2020.
Eighteen patients with Parkinson´s disease normally treated with Duodopa®/Duopa® were studied at three separate occasions – on one day with a continuous intravenous infusion of Infudopa IntraV™, on another day with a continuous subcutaneous infusion of Infudopa SubC™ and on a third day with continuous duodenal administration of Duodopa®/Duopa®. Each administration lasted for 16 hours.
The patients varied with respect to their regular Duodopa®/Duopa™ dose requirements, those at highest dosage receiving 2019 mg/day. Doses of Infudopa IntraV™ and Infudopa SubC™ were adjusted to be equivalent to the regular Duodopa®/Duopa® dose for the patient in question.
The aim of the study was to show non-inferiority of Infudopa SubC™ and Infudopa IntraV™ versus Duodopa®/Duopa® with respect to serum concentrations of levodopa, including absence of major fluctuations.
A preliminary analysis of the data reveals rapid uptake and stable serum levels of levodopa in patients administered Infudopa SubC™ and Infudopa IntraV™, the bioavailability of levodopa following Infudopa SubC™ being higher than after duodonal administration and on par with that observed when Infudopa™ was administered intravenously. In patients with high levodopa requirements, serum levels above 3500 ng/ml were swiftly achieved.
The tolerability of the given treatments was excellent, mild initial pain or discomfort upon subcutaneous administration and occasional transient hematomas being the most common side effect.
Final results will be presented in H2 2020
* Pharmacokinetics defines what the body does to the drug. Pharmacokinetics is the study of a drug´s absorption, distribution, metabolism and elimination from the body. The pharmacokinetic properties determine the onset, intensity, and the duration of drug action.
Clinical tolerability study*
A clinical outpatient tolerability study is scheduled to start in H1 2021. The duration, size and design of this study is pending consultations with relevant authorities.
* A clinical study is a research trial involving human subjects. Tolerability refers to the occurrence of adverse effects of a drug and how these are tolerated by the patient.