FDA Approves Enteral Suspension Medication for the Treatment of Parkinson's Disease
The FDA today approved AbbVie's Duopa (carbidopa and levodopa) enteral suspension for the treatment of motor fluctuations in patients with advanced Parkinson's disease.
The FDA today approved AbbVie’s Duopa (carbidopa and levodopa) enteral suspension for the treatment of motor fluctuations in patients with advanced Parkinson's disease.
Parkinson’s disease is a progressive and chronic movement disorder resulting from the loss of dopamine-producing brain cells. In addition to experiencing dyskinesia (uncontrolled movement that does not interfere with normal activities), patients with advanced Parkinson’s disease may fluctuate between “on time” and “off time,” in which they experience poor mobility, slowness, and stiffness.
“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, MD, 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 Parkinson’s disease patients, the spontaneous emptying of the stomach becomes delayed and unpredictable, which can affect the timing of when oral medications are absorbed in the small intestine. Duopa avoids this problem by delivering the same active ingredients as carbidopa-levodopa immediate-release (IR) oral tablets in a suspension that goes directly into the small intestine via a tube placed by a percutaneous endoscopic gastrostomy procedure with jejunal extension (PEG-J).
“The FDA approval of Duopa is another significant milestone for AbbVie’s pipeline,” said Michael Severino, MD, Abbvie Executive Vice President, Research and Development and Chief Scientific Officer, in a press release. “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.”
The FDA based its approval on a phase 3, 12-week, double-blind, double-placebo, active control, parallel group, multicenter trial in which the efficacy and safety of Duopa were compared with those of oral carbidopa-levodopa IR tablets in patients with advanced Parkinson’s disease. The research team found that Duopa significantly reduced daily mean “off time” at 12 weeks by 4 hours, which resulted in an average of 1.9 fewer hours of “off time” compared with carbidopa-levodopa IR tablets. Treatment with DUOPA was also associated with an improved mean “on” time without dyskinesia by 4 hours at 12 weeks, which resulted in an average of 1.9 more hours of “on” time compared with carbidopa-levodopa IR tablets.
“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, in a press release. “Our organization is encouraged by the introduction of a new therapy that may provide another treatment option for affected patients and families.”
The most common adverse events experienced by patients treated with Duopa (>7% and greater than carbidopa and levodopa IR tablets) were complication of device insertion, nausea, constipation, incision site erythema, dyskinesia, depression, post procedural discharge, peripheral edema, hypertension, upper respiratory tract infection, oropharyngeal pain, atelectasis, confusional state, anxiety, dizziness, and hiatal hernia.