Duodopa (Levodopa/Carbidopa Suspension for Intraduodenal Infusion)
Chemical Name and Structure
The chemical name for levodopa is (-)-3-(3,4-dihydroxyphenyl)-L-alanine.
The chemical name for carbidopa is (-)-L-µ-hydrazino-3,4-dihydroxy-µ-methylhydrocinnamic acid monohydrate.
Dosage Form/Device Description
Duodopa drug product is an aqueous suspension formulation containing levodopa (20 mg/g) and carbidopa (5 mg/g) as the active ingredients. The suspension is dispensed into cassettes which are designed to be connected to an ambulatory pump and their contents delivered via continuous intraduodenal infusion. Duodopa is stable in cassettes for 24 hours at room temperature.
For the clinical trial, Duodopa suspension is filled into 100-ml capacity, PVC bags housed in polycarbonate medication cassettes. The cassettes are supplied by SIMS Deltec, Inc., St. Paul, Minnesota. The CADD-PCA Ambulatory Infusion Pump Model 5800 is used for delivery of the Duodopa suspension, also supplied by SIMS Deltec.
Proposed Indication
NeoPharma plans to propose the following indication for Duodopa:
Treatment of patients with advanced Parkinson’s disease who are experiencing motor complications (wearing-off, dyskinesia) with functional disability and who can no longer be adequately controlled by oral levodopa/carbidopa alone or in combination with dopamine agonists or other adjunctive treatments.
