Parkinson’s disease is a progressive neurodegenerative illness characterized by reduced dopamine levels in the brain, resulting in a debilitating decrease in the patient’s motor and non-motor functions. Its symptoms, such as trembling in the extremities and face, slowness of movement and impaired balance and coordination, worsen over time and gravely impact the patient’s quality of life. As the disease progresses, these symptoms become more severe, resulting in debilitating periods of decreased motor and non-motor functions, also referred to as “off” time. In addition, mainly as a result of excessive oral doses of levodopa aimed at treating the “off” time, some patients experience involuntary movements, or dyskinesia. The “off” time and dyskinesia affect the majority of Parkinson’s disease patients and interfere with day-to-day functions, causing patients to become severely disabled.
Two to five years from disease diagnosis, patients can go from “on” to “off” in a rapid and sometimes erratic manner and experience an average of six hours of “off” time at various and unpredictable times throughout the day.
Over five million people worldwide, including at least one million in the United States, representing an estimated one in one hundred people over age 60, suffer from Parkinson’s disease. According to the International Parkinson and Movement Disorder Society, the prevalence of diagnosed patients with the disease will likely double from 2010 to 2040 due to increased life expectancy.
There are three main stages of Parkinson’s disease: mild, moderate and severe. Patients suffering from moderate to severe Parkinson’s disease constituted 60% of all Parkinson’s disease patients in 2011.
For over 30 years, oral administration of Levodopa/Carbidopa (LD/CD) has been the gold standard for treating Parkinson’s disease. Levodopa crosses into the brain and converts into dopamine to complement the reduced brain-dopamine levels. Virtually all patients diagnosed with Parkinson’s disease will require levodopa at some point over the course of their treatment for the disease, and 70% to 80% of patients receive the drug at any given point in time. However, despite its widespread acceptance, oral LD/CD has significant limitations, primarily a short duration in the blood, or short half-life, as well as low absorption and availability in the body. As a result, plasma levodopa concentrations fluctuate sharply, contributing to patients’ motor complications which include erratic “off” and “on” periods as well as to the narrowing of the therapeutic window over time, i.e. higher doses are required to turn a patient “on” but this may also result in dyskinesia. In the advanced stages of the disease, patients do not respond to oral administration of LD/CD, motor complications are exacerbated, and patients are left with limited treatment options that are highly invasive and/or burdensome.
NeuroDerm has developed patented liquid formulations that, for the first time, enable 24-hour, day and night, continuous subcutaneous administration of LD/CD to overcome these limitations, maintain steady therapeutic levodopa levels and offer patients an improved quality of life. NeuroDerm’s LD/CD portfolio includes three product candidates, for moderate, moderate to severe and very severe PD patients, all aimed at overcoming the most significant limitations of current LD/CD therapy.