FDA Approves New Drug for Parkinson's: Duopa

One more drug in the treatment toolbox...

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A new way to deliver dopamine replacement. SCIEPRO / Science Photo Library / Getty Images

Parkinson’s disease is a progressive neurodegenerative illness. With time, symptoms become more difficult to manage resulting in patients needing to take more medication more frequently. Eventually even with frequent dosing, patients may begin to experience motor fluctuations and more “off” times (experienced as slowness, stiffness and poor mobility) as the medications wear off between dosages. This phenomenon is one of the challenges in managing advanced Parkinson’s disease.

Hoping to address this issue and improve quality of life for patients farther along in their illness, a new medication was recently approved by the FDA although it has already been available in 41 countries outside of the U.S. (including Canada) – Duopa.

A type of dopamine replacement, Duopa is a gel formulation of levodopa/carbidopa that is delivered directly into a patient’s small intestine to improve absorption. It is delivered by a surgically placed tube which is then attached to a small pump that delivers the medication 16 hours per day, thereby bypassing the stomach and improving absorption.

Immediate release carbidopa / levodopa (commonly known as Sinemet) has been around for over 50 years and is still considered the gold standard when it comes to Parkinson’s treatment. For this reason, during the recent clinical study that showed its efficacy, Duopa was compared to this standard in treatment.

The multicenter study, was lead by C. Warren Olanow M.D., Professor, Department of Neurology and Department of Neuroscience, Mount Sinai School of Medicine. They enrolled 71 patients with advanced Parkinson’s and divided them into two groups, one receiving levodopa / carbidopa orally and the other receiving it through the pump.

By the end of the 12 week research trial, those in the group receiving Duopa had a reduction in their “off” times by 4 hours, an average of 1.9 hours less off time compared to the immediate release group. This translated to a mean of 1.9 hours more “on” time in the Duopa group. The most common adverse events seen were related to the device such as infection or the tube bending, knotting or moving out of place.

Prime candidates for Duopa are patients with advanced Parkinson’s disease that normally respond to levodopa but who despite available medications, continue to suffer from severe motor fluctuations or dyskinesias. This may be particularly useful in patients that do not qualify for deep brain stimulation (DBS) due to age, cognitive issues or are at increased risk for surgical complications. A study comparing DBS to Duodopa (as it is known outside the U.S.) showed an improvement in Parkinson’s measures in both the group that underwent DBS as well as those that received Duodopa. Essentially they both had a reduction in waking “off” times.

Although a cure is the ultimate goal, more and more medical research is being directed towards improving quality of life for patients while the search for a Parkinson’s cure continues. This includes methods to deliver a compound that for decades, has proven to help control the motor symptoms of Parkinson’s disease. Duopa has been shown to work and may be one more option for patients with advanced disease to maintain or improve their quality of life.

References Used:

Merola, Aristide, Maurizio Zibetti, Serena Angrisano, Laura Rizzi, Michele Lanotte, and Leonardo Lopiano. "Comparison of Subthalamic Nucleus Deep Brain Stimulation and Duodopa in the Treatment of Advanced Parkinson's Disease." Movement Disorders 26.4 (2011): 664-70. Web.

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