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| |  Ropinirole Relieves Symptoms of Early Parkinson's Disease SAN FRANCISCO, Calif., -- March 26, 1996 -- Results of three clinical studies demonstrating the effectiveness of Ropinirole, a dopamine D2 receptor agonist, for the treatment of patients with early Parkinson's disease, were presented today at the American Academy of Neurology. -- A six month multicenter, double-blind, placebo-control study on the efficacy and safety of Ropinirole evaluated in patients with Parkinson's disease who had previously not been treated with any anti- Parkinson therapy, was reported by David Wheadon, MD, Ropinirole (NYSE: SBH, SBE). Two hundred forty one patients participated in the study. The Ropinirole treated patients showed a statistically significant difference in improved motor function over placebo-treated patients (+24 percent for Ropinirole versus -3 percent for placebo), using the Unified Parkinson's Disease Rating Scale (UPDRS) motor score. Additionally, a statistically significant difference was noted between treatment groups for L-dopa rescue -- 29 percent for placebo compared to 11percent for Ropinirole-treated patients. Ropinirole was well- tolerated. The majority of adverse events were related to peripheral dopaminergic activity. -- In the second study, Professor Amos D. Korczyn, Ichilor Hospital, Tel Aviv, Israel, presented data from a planned six month interim analysis of a three-year, double-blind, multicenter study comparing Ropinirole and bromocriptine, a currently available therapy for Parkinson's disease, in patients with early Parkinson's disease. Comparing the UPDRS motor scores in the non-selegiline groups, there was a statistically significant difference in improvement between Ropinirole (34 percent) compared to bromocriptine (20 percent). (Selegiline is commonly used as adjunctive therapy in the management of Parkinsonian patients.) -- The third study compared the efficacy and safety in patients with early Parkinson's disease treated with Ropinirole alone or with L-dopa alone. Professor O. Rascol, Laboratoire de Pharmacologie Medicale et Clinique, Toulouse, France, presented data at a six month planned interim analysis of a five year, double-blind, L-dopa-controlled study in 268 patients. The results showed that Ropinirole was effective in early Parkinson's disease, successfully maintained patients for six months and delayed the introduction of L-dopa for that time period. However, the results of the five-year study are needed to determine whether the delays in the introduction of L-dopa reduce the later-stage complications. Parkinson's disease is progressive with the symptoms increasing in severity with the duration of the disease. Between 500,000 and one million Americans are estimated to be diagnosed with Parkinson's disease. The major symptoms associated with Parkinson's disease including tremors, jerking motions, a shuffling walk or short gait and balance problems. More severe symptoms include severe or intense tremors, limited mobility, difficulty turning and increased A fourth study showing the effectiveness of Ropinirole as adjunctive therapy in Parkinson's disease patients not optimally controlled with L-dopa will be presented on Thursday. Ropinirole (Requip(TM), SmithKline Beechham) is currently under review at the United States Food and Drug Administration.
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