FDA approves AbbVie's Duopa

NORTH CHICAGO, Ill. — AbbVie earlier this week announced that the Food and Drug Administration approved its Duopa (carbidopa and levodopa) enteral suspension, which is used to treat motor fluctuations for people with advanced Parkinson's disease. 

 

The drug is administered through a small, portable infusion pump. The pump delivers carbidopa and levodopa directly into the small intestine for 16 continuous hours by way of a procedurally placed tube. Duopa was given an orphan drug designation by the FDA. 

 

“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,” said C. Warren Olanow, M.D., professor, department of neurology and department of neuroscience, Mount Sinai School of Medicine, and lead investigator of the Duopa pivotal trial. “In clinical trials, Duopa was shown to significantly reduce the amount of off time advanced Parkinson’s disease patients experienced.”

 

In the advanced stages of Parkinson's disease, patients may experience bouts of poor mobility, slowness and stiffness. The spontaneous emptying of the stomach becomes delayed and unpredictable for patients with the disease, which can affect the timing of when orally administered medicines leave the stomach and are absorbed in the small intestine, the company stated. Duopa delivers the same active ingredients as orally administered arbidopa and levodopa, but is delivered in a suspension that goes directly into the small intestine. 

 

“The FDA approval of DUOPA is another significant milestone for AbbVie’s pipeline,” said Michael Severino, M.D., EVP, research and development and chief scientific officer at AbbVie. “This advancement is important for patients with advanced Parkinson’s disease and their care teams, as it provides a new therapeutic option to help manage motor symptoms.”