Once Daily, Extended-Release Ropinirole Improves Parkinson's Symptoms in Patients not Optimally Controlled With Levodopa

RESEARCH TRIANGLE PARK, N.C., April 02, 2007 /PRNewswire/ -- Adding the once daily, investigational medication REQUIP(R) (ropinirole HCl) XL 24-Hour(TM) Extended-Release Tablets to Parkinson's patients' existing levodopa (L-dopa) therapy significantly reduced 'off' time, allowing patients to continue their daily activities for a longer period of time. 'Off time' describes the return of Parkinson's symptoms as a patient's medication wears off. The Ropinirole 24-Hour Prolonged Release Randomized, Controlled Study in Advanced Parkinson Disease (EASE-PD Adjunct Study) results, published in the April 3 issue of Neurology, show that adjunct treatment with REQUIP XL 24-Hour significantly reduced 'off' time by an average of more than two hours per day when compared to baseline prior to treatment.

"'Off' time is a common phenomenon for Parkinson's patients. When symptoms like slowness of movement, tremor and rigidity return due to wearing off of the patient's medication, it can be problematic, causing difficulty with simple activities and movement in patients with Parkinson's disease," said Rajesh Pahwa, M.D., Professor of Neurology, Director, Parkinson Disease and Movement Disorder Center, University of Kansas Medical Center, Kansas City, Kan., and lead investigator of the EASE-PD Adjunct study. "These study results are significant, and show that with the investigational REQUIP XL 24- Hour added to L-dopa, patients can have more than two additional hours per day, on average, without experiencing the disabling symptom of 'off ' time."

REQUIP(R) (ropinirole HCl) Tablets, the immediate-release (IR) formulation, is dosed three times daily. REQUIP XL 24-Hour has been designed to be given once daily and to have a simpler and faster titration schedule. In addition, it has been designed to provide a steady rate of absorption in the body to help reduce blood plasma fluctuations over 24 hours. In the EASE- PD Adjunct Study, REQUIP XL 24-Hour has been shown to be effective in treating both motor and non-motor symptoms of Parkinson's disease as an addition to L- dopa. GlaxoSmithKline sponsored this study as part of the clinical development program for the investigational 24-hour extended-release tablet dosage formulation of REQUIP. REQUIP XL 24-Hour is the proposed brand name for a once-a-day formulation of ropinirole for treating Parkinson's disease using SkyePharma Plc's proprietary GeoMatrix technology.

About the Study

The EASE-PD Adjunct study was a multi-center, double-blind, placebo- controlled study, conducted in patients with idiopathic Parkinson's disease not adequately controlled with L-dopa. Subjects were randomized (1:1) to receive REQUIP XL 24-Hour (n=202) or placebo (n=191) in addition to L-dopa, once daily for 24 weeks. The primary endpoint was mean change from baseline in awake time spent 'off' (measured via patient diaries). REQUIP XL 24-Hour decreased patients' awake time spent 'off' by an average of 2.1 hours per day, while placebo decreased awake time spent 'off' by 0.3 hours per day.

The study also included a wide variety of motor and non-motor secondary endpoints, including 'on' time which refers to the time during which medication is working and providing benefit, and 'on' time without troublesome dyskinesia which refers to 'on' time without involuntary movements interfering with function or causing discomfort, a common problem in Parkinson's disease. REQUIP XL 24-Hour significantly increased both 'on' time and 'on' time without troublesome dyskinesia by 1.6 hours per day (a greater than 12 percent increase) and reduced the percentage of 'off' time by more than 12 percent compared to baseline. REQUIP XL 24-Hour also improved sleep problems associated with Parkinson's disease, as measured by the Parkinson's Disease Sleep Scale total score.

There were other motor and non-motor secondary endpoints in the study publication that were statistically significant. However, there were no significant differences between REQUIP XL 24-Hour compared to placebo in PDQ- 39 subscales of social support, cognition or bodily discomfort. Additionally, there was no significant difference between REQUIP XL 24-Hour and placebo on the Epworth Sleepiness Scale total score signifying no increase in daytime sleepiness.

In the EASE-PD Adjunct study, once daily use of REQUIP XL 24-Hour was generally well tolerated. The withdrawal rate due to adverse events was low and similar between the two groups (REQUIP XL 24-Hour 5 percent versus placebo 5 percent). The most common adverse events reported in patients taking REQUIP XL 24-Hour (n=202) versus placebo (n=191) were dyskinesia (13 percent versus 3 percent), nausea (11 percent versus 4 percent), dizziness (8 percent versus 3 percent), somnolence (7 percent versus 4 percent), hallucinations (6 percent versus 1 percent), and orthostatic hypotension (5 percent versus 2 percent).

A Progressively Disabling Disease

Parkinson's disease is a chronic, progressive and debilitating neurological condition that impairs the body's ability to move and balance. Researchers have determined that Parkinson's disease involves pathways in the brain responsible for motor control that are functioning improperly. Patients with Parkinson's disease experience a reduction in dopamine, a key chemical in the brain that communicates messages about movement, resulting in the symptoms of Parkinson's disease. These symptoms may include bradykinesia (slower-than- normal voluntary movements), rigidity (stiffness), tremor (involuntary shaking) and postural instability (trouble with balance).

More than one million people in the United States have Parkinson's disease, and it is estimated that nearly 60,000 new cases are diagnosed in the U.S. each year. Most people develop Parkinson's disease between the ages of 40 and 70, but the disease can also develop at an earlier age.

About REQUIP Tablets (Immediate-Release Formulation)

The currently marketed REQUIP Tablets, a non-ergot dopamine agonist, has an indication in the U.S. for the treatment of the signs and symptoms of idiopathic Parkinson's disease and is administered three times a day.

Prescription REQUIP is not for everyone. REQUIP Tablets may cause patients to fall asleep or feel very sleepy during normal activities such as driving; or to faint or feel dizzy, nauseated, or sweaty when they stand up. Patients should tell their doctor if they experience these problems or if they drink alcohol or are taking other medicines that make them drowsy. Patients should also tell their doctor if they or their family notices that they develop any unusual impulses or behaviors, such as pathological gambling or hypersexuality. Hallucinations may occur at anytime during treatment. REQUIP may potentiate the side effects of L-dopa. Side effects include nausea, dizziness, drowsiness or sleepiness, headache, and dyskinesia (uncontrolled movements). Most patients were not bothered enough to stop taking REQUIP. This is not a complete list of side effects and should not take the place of discussions with patients' healthcare providers. Their doctor or pharmacist can give patients a more complete list of side effects. Patients should talk to their doctor about any side effects they may have.

About SkyePharma PLC

SkyePharma develops pharmaceutical products benefiting from world-leading drug delivery technologies. The Company has nine approved products in the areas of oral, inhalation and topical delivery that are marketed throughout the world by leading pharmaceutical companies. For more information, visit www.skyepharma.com.

About GlaxoSmithKline

GlaxoSmithKline, with U.S. operations in Philadelphia and Research Triangle Park, N.C., is one of the world's leading research-based pharmaceutical and health care companies.

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CONTACT: Robin Gaitens of GlaxoSmithKline, +1-919-483-2839; or Patricia Liof Cohn & Wolfe, +1-212-798-9772, for GlaxoSmithKline

Web site: http://www.gsk.com/http://www.skyepharma.com//

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