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Duopa (Carbidopa/Levodopa) Enteral Suspension Wins FDA Nod for Treatment of Motor Fluctuations in Parkinson’s Patients
The FDA has given the green light to Duopa (carbidopa and levodopa, AbbVie) enteral suspension for the treatment of motor fluctuations in patients with advanced Parkinson’s disease (PD).
The treatment 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 had received “orphan drug” status, a designation granted to products intended for the treatment of rare diseases or conditions affecting fewer than 200,000 patients in the U.S.
In the advanced stages of PD, patients may begin to experience “off” time, or periods of poor mobility, slowness, and stiffness. In addition, in PD patients, the spontaneous emptying of the stomach becomes delayed and unpredictable, which can affect the timing of when orally administered medications 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 (IR), but it 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’s approval of Duopa was based on results from a phase III, 12-week, double-blind, double-placebo, active-control, parallel-group trial that compared the efficacy and safety of Duopa with that of oral, IR carbidopa/levodopa tablets in 71 patients with advanced PD. The study showed that Duopa significantly reduced daily (per 16 waking hours) mean “off” time by 4 hours at 12 weeks, 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 (periods when the medication is working and symptoms are controlled) without troublesome dyskinesia by 4 hours at 12 weeks, which resulted in an average of 1.9 hours more “on” time compared with carbidopa/levodopa IR tablets.
The most common adverse events included complications 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.
Duopa was reviewed and approved by the FDA as a combination product administered with the CADD Legacy 1400 pump.
Carbidopa/levodopa enteral suspension is currently approved in 41 countries and is marketed as Duodopa outside the U.S.
PD is classified as a movement disorder resulting from the loss of dopamine-producing brain cells. The motor symptoms of PD begin when approximately 60% to 80% of the dopamine-producing cells in the brain are lost, and symptoms continue to worsen slowly over time. As PD progresses, patients may experience dyskinesias. While there is no known cure for the disease, treatments are available to help reduce symptoms.
In the U.S., an estimated 60,000 new cases of PD are reported each year, adding to as many as 1 million people who currently have the disease.
Sources: AbbVie; January 12, 2015; and Duopa Prescribing Information; January 2015.