US FDA approves AbbVie’s Duopa for Parkinson’s disease

The US Food and Drug Administration has approved US drugmaker AbbVie’s (NYSE: ABBV) Duopa (carbidopa and levodopa) enteral suspension for the treatment of motor fluctuations for people with advanced Parkinson’s disease.

Duopa is administered using a small, portable infusion pump that delivers carbidopa and levodopa directly into the small intestine for 16 continuous hours via a procedurally-placed tube. It was approved by the FDA as an orphan drug, a designation granted to products intended for the treatment of rare diseases or conditions affecting fewer than 200,000 patients in the USA.

Warren Olanow, professor at the Department of Neurology and Department of Neuroscience, Mount Sinai School of Medicine, and lead investigator of the Duopa pivotal trial, said: “There is unmet need for treatment options for patients with advanced Parkinson’s disease. As the disease advances, it can be difficult to control motor features. In clinical trials, Duopa was shown to significantly reduce the amount of off time advanced Parkinson's disease patients experienced.”