New Study Reveals Investigational 24-Hour Formulation of Requip(R) (ropinirole HCl) Tablets Reduced "Off" Time for Patients With Parkinson's Disease

Average Awake Time Spent "Off" Decreased by 2.1 Hours Per Day

By: Marketwire
Sep. 4, 2006 01:30 PM
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RESEARCH TRIANGLE PARK, NC -- (MARKET WIRE) -- 09/04/06 -- The addition of investigational Requip® (ropinirole HCl) extended-release tablets to Parkinson's patients existing therapy delayed "off" 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 today 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 (L-dopa). The extended-release form of Requip used in the study was a 24-hour dosage formulation not yet approved by the U.S. 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 Center, University of Kansas Medical Center, 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 (LSE: SKP) (NASDAQ: SKYE) and is based on SkyePharma oral controlled release proprietary technology.

About the EASE-PD Adjunct Study

EASE-PD Adjunct was a multi-center, 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. Initial dose was 2 mg/day, titrated to 6 mg/day over 3 weeks, and adjusted thereafter (to a maximum of 24 mg/day) to achieve optimal therapeutic response. Once titrated to 8 mg/day, and for each subsequent increase, L-dopa dose reduction was required. Mean (SD) L-dopa dose at baseline was 824 (424.4) mg/day and 776 (357.3) mg/day in patients taking Requip 24-hour extended-release and patients taking placebo, respectively; mean (SD) reduction in L-dopa dose at Week 24 last observation carried forward (LOCF) was -278 (192.6) mg/day and -164 (163.9) mg/day. The primary endpoint was mean change from baseline in awake time spent "off" (measured via patient diaries) at Week 24 LOCF. Requip 24-hour extended-release significantly decreased patients' awake time spent "off" by an average of 2.1 hours per day compared to placebo, which was 0.4 hours per day.

In the EASE-PD Adjunct study data presented at this European Federation meeting, the most common adverse events reported in the Requip 24-hour extended-release tablets group (n=202) versus placebo (n=191) were dyskinesia (13% versus 3%), nausea (11% versus 4%), dizziness (8% versus 3%), somnolence (7% versus 4%), hallucinations (6% versus 1%), and orthostatic hypotension (5% versus 2%). The withdrawal rate due to adverse events was low and similar between the two groups (Requip 24-hour extended-release 5% versus placebo 5%).

A Progressively Disabling Disease

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 U.S. Typically Parkinson's disease starts around age 60. However, one in seven Parkinson's disease patients is diagnosed before the age of 40 (young-onset Parkinson's disease).

About Requip Tablets

Requip is an orally administered non-ergoline dopamine agonist that directly stimulates dopamine in the brain. Requip is indicated for the treatment of the signs and symptoms of idiopathic Parkinson's disease and is available in an immediate-release (IR) formulation and a variety of tablet strengths for flexible dosing up to 24 mg/day to meet individual patient's needs.

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 medications that make them drowsy. 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.