The addition of investigational Requip extended-release tablets to Parkinson's patients existing therapy delayed time a well-known phenomenon in which symptoms return as patients' medication wears off by an average of more than two hours per day when compared to placebo, according to new data presented at the annual European Federation of Neurological Societies Congress.
The 24-week study, called the EASE-PD (Efficacy And Safety Evaluation in Parkinson's Disease) Adjunct study, involved patients with Parkinson's disease not adequately controlled with levodopa. The extended-release form of Requip used in the study was a 24-hour dosage formulation not yet approved by the US Food and Drug Administration.
"Patients have indicated that the return of Parkinson's disease symptoms as their L-dopa dose wears off can be problematic for them," said Rajesh Pahwa, M.D., Professor of Neurology, Director, Parkinson Disease and Movement Disorder Centre, University of Kansas Medical Centre, Kansas City, Kan., and lead investigator of the EASE-PD Adjunct study. "We are excited about the results of this study, which showed that patients benefited from an average reduction of 2.1 hours in awake time spent 'off.' In other words, many patients were able to manage their Parkinson's disease symptoms for a longer period of time when adding Requip 24-hour extended-release to their treatment regimen."
Requip, in its immediate-release (IR) formulation, is dosed three times daily and has been shown to be effective in treating the motor symptoms of Parkinson's disease as monotherapy or adjunct to L-dopa. GlaxoSmithKline conducted this study as part of the clinical development program for the investigational 24-hour extended-release tablet dosage formulation of Requip. The new formulation has been developed in collaboration with SkyePharma Plc and is based on SkyePharma oral controlled release proprietary technology.
EASE-PD Adjunct was a multi-centre, double blind, parallel-group, placebo-controlled pivotal study, and was conducted in patients with idiopathic Parkinson's disease not adequately controlled with L-dopa. Subjects were randomized (1:1) to adjunctive Requip 24-hour extended-release tablets (n=202) or placebo (n=191), once daily for 24 weeks.
Parkinson's disease is a chronic, debilitating and progressive degenerative neurological condition that affects movement and balance in the body. Patients with Parkinson's disease experience a reduction in dopamine, a key chemical messenger in the brain that communicates messages about movement in the body. This reduction in dopamine causes a patient's movements to become more uncontrolled, with either too much movement (tremor or gait instability) or too little movement (slowness or rigidity). It affects more than one million people in the US typically Parkinson's disease starts around age 60. However, one in seven Parkinson's disease patients is diagnosed before the age of 40.