KNI Physician Helps Patients with Parkinson's Using Newly-Approved Drug

LEXINGTON, Ky. (March 9, 2015) -- To date, a cure for Parkinson's disease remains elusive for the more than 50,000 Americans diagnosed yearly, despite decades of intensive study.  But a newly approved treatment that might help ease the symptoms of Parkinson's has shown remarkable promise.

Parkinson’s is a progressive disease caused by the death of dopamine-producing cells in the brain. While most people recognize a Parkinson's patient by their motor skill difficulties such as tremor, slowness and stiffness, the disease also gives rise to several non-motor types of symptoms such as sensory deficits, cognitive difficulties or sleep problems.

While doctors have a number of treatments available to help manage the symptoms of Parkinson's disease, the motor deficits that are the hallmarks of PD are also the nemesis of effective treatment, since the muscles that control digestion are also affected, making dosing -- both in terms of amount and timing -- challenging.

Compounding this challenge is the fact that medications lose effectiveness over time as cell death progresses. Although levodopa remains the “gold standard” to control motor deficits in the treatment of early stage PD, after four to six years of treatment with oral medications for Parkinson’s disease, about 40 percent of patients find those medications less effective overall, inconsistent in controlling muscle function, and accompanied by a bothersome side-effect called dyskinesia, or involuntary muscle movement. By nine years of treatment, about 90% will suffer these effects.

Dr. John Slevin, professor of Neurology and Vice Chair of Research at UK's Kentucky Neuroscience Institute, worked with an international team of investigators to explore the efficacy of continuous levodopa dosing using a specially developed gel called CLES (Duopa®) that is delivered directly into the small intestine by a portable infusion pump.  

"We were extremely pleased with the results," Slevin said.  “Patients with advanced PD treated via this new method demonstrated marked improvement in symptom fluctuations with reduced dyskinesia.“

According to Slevin, CLES's effectiveness is due in part to the fact that it results in more stable plasma concentrations of levodopa by delivering it directly to the small intestine, which bypasses issues of erratic gastric emptying and absorption caused by reduced muscular function inherent to PD.

"CLES has the potential to address a significant unmet need in this patient population with limited therapeutic options," Slevin added. 

The FDA approved CLES in January 2015. Because the safety and efficacy of levodopa is already established, this treatment has the potential to be fast-tracked for widespread use within the next 4-6 months.

"In fact, my first research patient is scheduled to switch to ongoing treatment with CLES this month," Slevin said. 

Results from the study were published in the current issue of the Journal of Parkinson’s Disease. The article is available at http://iospress.metapress.com/content/04427r3701341251/fulltext.pdf.