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Discovery Therapeutics' Parkinson's Skin Patch Gives Positive Interim Results in Phase IIb Clinical Trial Source: Business Wire RICHMOND, Va.--(BW HealthWire) via Individual Inc. -- Discovery Therapeutics, Inc. today revealed preliminary results from a scheduled interim analysis of data from the company's Phase IIb clinical trial testing its dopamine agonist transdermal patch for Parkinson's disease. The N-0923 patch fully replaced existing oral agonist therapy and reduced daily levodopa dosage in all four patient treatment groups by an average of 20-30% compared to baseline; statistically significant differences were detected in two of the four dosage groups, despite the small sample size and the placebo effect typical in such studies. This double-blind, placebo-controlled study is ongoing at multiple centers in North America. The study is designed to test the N-0923 patch in a total of 75 patients in five dosage arms, including one placebo group, for 21 days. Patients are taken off their regular dopamine agonists and levodopa treatments before starting treatment with the patch. Levodopa is then added back as needed to maintain control of symptoms. Primary endpoints include the amount of levodopa used and Clinical Global Impression (CGI) scores. The interim analysis was scheduled to cover the first 14 days of treatment in the first 25 patients (5 patients per treatment group). All patients tolerated the immediate transition to the N-0923 patch well, with no need for dose titration. The patch was fully efficacious throughout the treatment period. There were no dropouts from the study and no serious or unexpected adverse events. While the small sample size in this interim analysis was insufficient to detect differences in all dose groups and in CGI scores, statistical power calculations indicate that meaningful differences should be detectable in the full 75-patient study. Discovery Therapeutics, Inc. is an independent company founded to invent, develop and commercialize pharmaceuticals for poorly-met medical needs using novel signal molecule technologies. Discovery Therapeutics has two technology platforms: one based on dopamine for the treatment of movement disorders and the other on adenosine for the treatment and diagnosis of coronary artery disease and cardiac dysrhythmias. CONTACT: Discovery Therapeutics, Inc. | Dr. Donald A. McAfee, 804/358-9468 | or | EMM Communications | Ellen M. Martin, 510/832-7604 [02-11-97 at 08:03 EST, Business Wire] Contact: Business Wire