FDA Approves DUOPA(TM) Enteral Suspension for the Treatment of Advanced Parkinson's Disease

Newport Beach Man and Study Participant Notices Vast Improvement in Quality of Life

FOUNTAIN VALLEY, Calif. – The U.S. Food and Drug Administration (FDA) has approved DUOPA™ (carbidopa and levodopa) enteral suspension for the treatment of motor fluctuations in patients with advanced Parkinson’s disease (PD).

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.

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. Daniel Truong, M.D., medical director and founder of The Parkinson’s and Movement Disorder Institute at Orange Coast Memorial Medical Center in Fountain Valley, CA, was a clinical investigator in the study. Dr. Truong had enrolled 8 patients in the study.

“I am extremely proud to have participated in and collaborated with my esteemed colleagues on this landmark study,” said Dr. Truong. “With limited treatment options for patients with advanced Parkinson’s disease, DUOPA provides a clinically effective treatment that helps regulate the motor fluctuations which can cause periods of poor mobility and excessive movements. With DUOPA, we can nearly normalize patient mobility and improve their quality of life.”

In the advanced stages of PD, patients may begin to have fluctuation with “off” time, or periods of poor mobility, slowness and “dyskinesia,” a period of excessive involuntary movements. Additionally, in PD patients the spontaneous emptying of the stomach becomes delayed and unpredictable which can affect the timing of when orally administered medicines 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.

For study participant and retired orthopedist James Moore, M.D., 70, of Newport Beach, CA, DUOPA has significantly enhanced his quality of life since he participated in this study in 2012. Diagnosed with Parkinson’s in 2000, Dr. Moore experienced the common symptoms associated with the disease such as shaking, shuffling, and slowness.

“For me, it was beautiful. I have even begun playing golf again,” explained Dr. Moore. “My quality of life has increased immensely, and I honestly think that my back pain now limits me more than Parkinson’s.”

To learn more about DUOPA, please call The Parkinson’s and Movement Disorder Institute at Orange Coast Memorial Medical Center at (714) 378-5062.