New Enteral Suspension OK'd for Parkinson's Disease
AbbVie announced that the Food and Drug Administration (FDA) has approved Duopa (carbidopa and levodopa) enteral suspension for the treatment of motor fluctuations for people with advanced Parkinson's disease.
Duopa enteral suspension is given via a small, portable infusion pump that delivers carbidopa and levodopa into the small intestine for 16 hours through a procedurally-placed tube.
The FDA approval was based on a Phase 3, 12-week, double-blind, double-placebo, active control, parallel group, multi-center trial that evaluated Duopa vs. oral, immediate-release (IR) carbidopa-levodopa tablets in 71 advanced Parkinson's disease patients. In the study, treatment with Duopa significantly reduced daily mean "off" time at 12 weeks by 4 hours, which led to an average of 1.9 fewer hours of "off" time vs. carbidopa-levodopa IR tablets. Also, Duopa improved mean "on" time without troublesome dyskinesia by 4 hours at 12 weeks, which led to an average of 1.9 hours more "on" time vs. carbidopa-levodopa IR tablets.
Duopa will be available as 100mL single-use cassettes containing 4.63mg carbidopa and 20mg levodopa per 1mL of enteral suspension in 7-count cartons.
For more information call (800) 633-9110 or visit AbbVie.com.