FDA Approves DUOPA™ for Treatment of Motor Fluctuations in Advanced Parkinson’s Disease

The Parkinson’s Disease Foundation (PDF) alerts the community that DUOPA™, a gel formulation of the drug carbidopa/levodopa that is delivered directly to the small intestine through a surgically-placed tube, has been approved by the US Food and Drug Administration (FDA) for the treatment of motor fluctuations in advanced Parkinson's disease.  The drug’s manufacturer, AbbVie, Inc., announced the approval today. 

Carbidopa/levodopa is the gold-standard medication for the treatment of motor symptoms in Parkinson’s disease, and is most often taken orally as Sinemet(R). But as Parkinson’s disease advances, carbidopa/levodopa becomes effective for shorter time periods, making it necessary for people to take the drug four or more times a day. Even then, people taking carbidopa/levodopa experience periods in which the drug “wears off," meaning levodopa levels in the blood may drop and motor symptoms worsen before the next dose.  
These “off” times are particularly problematic in advanced Parkinson’s disease because gastrointestinal issues delay the medication’s ability to reach the small intestine, where the drug is absorbed.

The manufacturer of DUOPA™ states that the drug uses the same active ingredients as orally-administered carbidopa/levodopa, but is designed to improve absorption and reduce off-times by delivering the drug directly into the small intestine.  DUOPA™ is delivered for 16 continuous hours every day by a pump through a tube that requires a small surgically-placed hole in the stomach. 

DUOPA™ is currently approved and available in 41 countries. It is not known when it will be available to people with Parkinson’s disease in the US. According to the manufacturer, for people living with advanced Parkinson’s disease who face financial difficulties, patient assistance may be available.

According to Kathleen M. Shannon, M.D., Chair of PDF’s Medical Policy Committee and Professor of Neurological Sciences at Rush Medical College, this is a welcome advance for a subset of people living with advanced disease. “For people with advanced Parkinson’s disease who have significant difficulty with fluctuations in control of symptoms throughout the day that have not responded to changes in the dose of oral medications, DUOPA™ may provide better control of movement and improved quality of life,” says Dr. Shannon.  “This is especially true for people who are not candidates for deep brain stimulation surgery due to age, cognitive impairment or increased surgical risk. Most of the side effects are related to the delivery tube or the abdominal wall surgical site, including movement, knotting or clogging of the tube, and infections at the surgical site.  People living with advanced PD who think they might be candidates for this therapy should discuss their risk to benefit profile with their treating neurologists.”

PDF welcomes the addition of this new tool for clinicians and people with advanced Parkinson’s disease. People with advanced Parkinson’s disease should discuss the surgical procedure and potential side effects with their healthcare providers.

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