More than 5o,ooo Americans are diagnosed with Parkinson’s disease each year. Although a cure for the progressive neurological disorder remains elusive, a newly approved treatment shows significant promise in easing the often debilitating symptoms associated with the condition.
The new approach uses a specially developed gel of the medication levodopa delivered into the small intestine by a portable infusion pump.
John Slevin, M.D., M.B.A., Professor of Neurology and Vice Chair of Research at the Kentucky Neuroscience Institute of the University of Kentucky, worked with a team of international investigators to determine if providing a continuous flow of the specially developed gel called CLES (Duopa®) provided symptom relief.
“We were extremely pleased with the results,” Slevin said. “Patients with advanced Parkinson Disease (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.
Marion Cox knows this all too well. The 70-year old Georgetown farmer and former real estate developer has suffered from Parkinson’s for 16 years. “I could tell I was going the wrong way,” Cox says as he described his decline in spite of frequent medication adjustments. Even with his medications, he began to “stagger around” and struggled to speak and swallow.
He was frustrated that he couldn’t spend more quality time with his two daughters and two granddaughters. So when Slevin mentioned the Duopa clinical trial, Cox leapt at the chance.
“I felt different right away,” he says of his experience in the three-year trial. Cox said he can get around better, get dressed more easily, be gone all day farming his 800 acres.
“I’m getting more done. I’m not as good as I once was [before I had Parkinson’s] but I’m pretty darn well off,” he adds.
Parkinson’s is a progressive disease caused by the death of dopamine-producing cells in the brain. Parkinson’s is often identified by a slow shuffling gait, tremors 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 a challenge, both in terms of amount and timing.
Another issue is 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, its efficacy may dwindle with time.
In fact, for about 40 percent of patients the oral medications become inconsistent in controlling muscle function, and are accompanied by a bothersome side effect called dyskinesia, or involuntary muscle movement. By nine years of treatment, about 90 percent of PD patients will suffer these effects.
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 four to six months.