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news.The US Food and Drug Administration (FDA) has approved AbbVie's DUOPA (carbidopa and levodopa) enteral suspension for the treatment of motor fluctuations for people with advanced Parkinson's disease.
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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.
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 U.S.
"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 begin to experience "off" time, or periods of poor mobility, slowness and stiffness. Additionally, in Parkinson’s disease patients, the spontaneous emptying of the stomach becomes delayed and unpredictable, which can affect the timing of when orally administered medicines leave the stomach and are absorbed in the small intestine.
DUOPA provides patients with the same active ingredients as orally-administered carbidopa and levodopa immediate release, but is delivered 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). This type of administration is intended to bypass the stomach.
"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."
The DUOPA approval is based on a Phase 3, 12-week, double-blind, double-placebo, active control, parallel group, multi-center trial (N=71) that compared the efficacy and safety of DUOPA to oral, immediate-release (IR) carbidopa-levodopa tablets in advanced Parkinson’s disease patients.
The study showed that DUOPA significantly reduced daily (per 16 waking hours) mean "off" time at 12 weeks by four hours, which resulted in an average of 1.9 fewer hours of "off time" when compared to carbidopa-levodopa IR tablets.
Treatment with DUOPA was also associated with an improved mean "on" time (periods when the medication is working and symptoms are controlled) without troublesome dyskinesia (uncontrolled movement that does not interfere with normal daily activities) by four hours at 12 weeks, which resulted in an average of 1.9 hours more "on" time when compared to carbidopa-levodopa IR tablets.
The most common adverse events (>7% and greater than carbidopa and levodopa immediate release) 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.