FDA Approves New Enteral Treatment for Parkinson's Disease

The US Food and Drug Administration (FDA) approved AbbVie’s DUOPA (carbidopa and levodopa) enteral suspension for treating motor fluctuation in individuals afflicted with advanced Parkinson’s disease. 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 under its orphan drug program, which expedites approval for treatments for rare diseases or conditions that affect fewer than 200,000 patients in the US. DUOPA has been approved in 41 countries and marketed by AbbVie as DUODOPA outside the United States.

The FDA approved DUOPA based on efficacy and safety data from a 12-week, double-blind, double-placebo, active control, parallel group, multi-center trial (N=71) that showed DUOPA significantly reduced daily (per 16 waking hours) mean "off" time at 12 weeks by 4 hours, which resulted in an average of 1.9 fewer hours of "off time" when compared to carbidopa-levodopa IR tablets.

C. Warren Olanow, MD, Professor in the Department of Neurology and Department of Neuroscience, Mount Sinai School of Medicine, and lead investigator of the DUOPA pivotal trial, said in a news release, “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. In clinical trials, DUOPA was shown to significantly reduce the amount of off time advanced Parkinson’s disease patients experienced.”

The news release also notes that spontaneous emptying of the stomach can be delayed and unpredictable in patients with Parkinson’s disease, which can “affect the timing of when orally administered medicines leave the stomach and are absorbed in the small intestine.” DUOPA is delivered directly into the small intestine via a tube placed by a percutaneous endoscopic gastrostomy procedure with jejunal extension, bypassing the stomach.

The most common adverse events reported during the clinical trial 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.

According to Michael Severino, MD, Executive Vice President, Research and Development and Chief Scientific Officer, AbbVie, the approval of DUOPA “is important for patients with advances Parkinson’s disease and their care teams, as it provides a new therapeutic option to help manage motor symptoms.”