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 primary aims of the study, to show bioequivalence of Infudopa SubC™ and Duodopa®/Duopa® with respect to levodopa levels in plasma, and non-inferiority with respect to plasma level fluctuations, were all met. A comparison of levodopa levels following Infudopa SubC™ and Infudopa IntraV™, respectively, shows levodopa bioavailability for Infudopa SubC™ to be close to 100%. Effects on motor symptoms were the same for the three treatment groups. Local side effects of Infudopa SubC™ at the infusion site were mild or moderate.
* 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 2022. 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.
For more information, please see the poster Rapid uptake and stable serum levodopa levels with continuous s.c. Infudopa (levodopa/carbidopa) administration.