FDA Clears Enteral Suspension (Duopa) for Parkinson's

Megan Brooks

Disclosures

January 12, 2015

The US Food and Drug Administration (FDA) has approved carbidopa/levodopa enteral suspension (Duopa, AbbVie) for the treatment of motor fluctuations in patients with advanced Parkinson's disease, according to a company news release.

"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)," the company explains.

The approval was based on a 12-week, phase 3, double-blind, multicenter trial that compared the efficacy and safety of the enteral suspension with those of oral, immediate-release (IR) carbidopa-levodopa tablets in 71 patients with advanced PD. The trial was led by C. Warren Olanow, MD, professor, Department of Neurology and Department of Neuroscience, Mount Sinai School of Medicine, New York, New York.

"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," Dr Olanow said in the company statement. "In clinical trials, Duopa was shown to significantly reduce the amount of off time advanced Parkinson's disease patients experienced."

Patients receiving the suspension had significantly reduced daily (per 16 waking hours) mean "off" time at 12 weeks by 4 hours, which led to an average of 1.9 fewer hours of "off" time compared with carbidopa-levodopa IR tablets.

The suspension also improved mean "on" time (periods when the medication is working and symptoms are controlled) without troublesome dyskinesia by 4 hours at 12 weeks, which led to an average of 1.9 hours more "on" time when compared with carbidopa-levodopa IR tablets.

The most common adverse events (>7% and greater than carbidopa and levodopa IR) were complication of device insertion, nausea, constipation, incision site erythema, dyskinesia, depression, postprocedural discharge, peripheral edema, hypertension, upper respiratory tract infection, oropharyngeal pain, atelectasis, confusional state, anxiety, dizziness and hiatal hernia.

"Due to the progressive nature of Parkinson's disease, it can be difficult to treat over time, especially in the advanced stages," Joyce Oberdorf, president and CEO of the National Parkinson Foundation, said in the release. "Our organization is encouraged by the introduction of a new therapy that may provide another treatment option for affected patients and families."

The FDA approved Duopa as an orphan drug, a designation granted to products intended to treat rare diseases or conditions affecting fewer than 200,000 patients in the United States.

Last week, the FDA approved a capsule formulation of carbidopa-levodopa (Rytary, IPX066, Impax Pharmaceuticals) for the treatment of PD, postencephalitic parkinsonism, and parkinsonism that may follow carbon monoxide intoxication or manganese intoxication.

Rytary contains IR and extended-release beads, with a specific amount of carbidopa and levodopa in a 1:4 ratio, and provides both initial and extended levodopa plasma concentrations after a single dose.

Full prescribing information, including the medication guide, can be found at www.rxabbvie.com.

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