New Parkinson's Disease Drug Requip
From SmithKline Beecham Cleared For Use By FDA

Philadelphia, PA, September 22, 1997

SmithKline Beecham's Requip (ropinirole hydrochloride) received marketing clearance today from the U.S. Food and Drug Administration (FDA) for treatment of the signs and symptoms of Parkinson's disease, both as initial therapy and as adjunctive treatment with levodopa. Unlike older dopamine agonists, Requip, which is a second generation dopamine agonist, is licensed for use in patients with early Parkinson's disease (without levodopa) and in patients with advanced Parkinson's disease (with levodopa). Currently, the standard treatment for Parkinson's disease is levodopa. Levodopa is very effective initially, but over time patients will need to increase their dosage to maintain control of symptoms.

A Progressive Neurodegenerative Disorder, Parkinson's disease, which affects between 500,000 and 1,000,000 Americans, is a chronic and progressive disorder which results from the death of nerve cells in a critical area of the brain called the substantia nigra. These nerve cells normally produce dopamine, a chemical messenger that plays an important role in motor movement control by transmitting signals between the substantia nigra and another critical area of the brain called the striatum. Dopamine depletion results in a patient's impaired ability to control motor movements. Requip is a highly selective second-generation dopamine agonist that works by mimicking the effects of dopamine.

Efficacy in Early Parkinson's Disease

The effects of Requip as initial therapy in patients with mild to moderate Parkinson's disease were assessed in a double-blind, randomized, placebo-controlled study. Results were obtained through a measurement used by physicians to assess the disease status of Parkinson's disease patients called the Unified Parkinson's Disease Rating Scale (UPDRS). Physicians measured the overall change they saw in their patients' motor function. Patients treated with Requip (n=116) demonstrated a significantly superior improvement in motor score of 24 percent compared to placebo-treated patients (n=125) who demonstrated a three percent worsening in motor score after six months. In addition, 33 percent of patients treated with Requip were rated as either "much improved" or "very much improved" on the Clinical Global Impressions (CGI) improvement item compared to 12 percent of patients given placebo.

Efficacy as Adjunctive Therapy With Levodopa

The efficacy of Requip as adjunctive therapy with levodopa in the late stages of Parkinson's disease was confirmed in a double-blind, randomized study comparing patients treated with Requip (n=94) to patients treated with placebo (n=54). Investigators evaluated the number of "responders," defined as patients who were able to achieve: (1) a decrease (compared to baseline) of at least 20 percent in their levodopa dose, and (2) a decrease of at least 20 percent in the proportion of time awake in the "off" condition (period of time during the day when patients are particularly immobile).

After six months, 28 percent of patients treated with Requip were classified as responders versus 11 percent of placebo-treated patients. This difference was statistically significant. In addition, 49 percent of Requip-treated patients had their levodopa dose reduced by at least 20 percent versus 17 percent of placebo-treated patients. This difference was also statistically significant. The average levodopa dose reduction was 31 percent for patients treated with Requip. This study demonstrates that the adjunctive use of Requip with levodopa allows for the reduction of a patient's levodopa dose, therefore reducing the total amount of levodopa which must be taken daily.

In both early and adjunct therapy studies, Requip was generally well tolerated. In the early therapy study, the most common adverse experience was nausea, which was related to the stimulation of dopamine receptors. Other adverse experiences that occurred less frequently included dizziness, somnolence and headaches. In the adjunctive therapy study, in patients already experiencing motor fluctuations, the most common adverse experience was dyskinesia. Other adverse experiences that occurred less frequently included nausea, dizziness, and somnolence. All Parkinson's patients should be informed that syncope or symptomatic hypotension may occur more frequently during initial treatment, and hallucinations can occur at any time during the course of treatment.

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