The FDA has approved AbbVie's 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, according to a press release.
DUOPA 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 United States.
"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."
"The FDA approval of DUOPA is another significant milestone for AbbVie's pipeline," said Michael Severino, M.D., Executive Vice President, Research and Development and Chief Scientific Officer, 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."
"Due to the progressive nature of Parkinson's disease, it can be difficult to treat over time, especially in the advanced stages," said Joyce Oberdorf, President and CEO, National Parkinson Foundation. "Our organization is encouraged by the introduction of a new therapy that may provide another treatment option for affected patients and families."
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