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news.Forest Laboratories has reported postive preliminary results of a Phase III study of memantine hydrochloride in a novel once-daily formulation.
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The company said that the study evaluated the efficacy, safety and tolerability of an innovative, proprietary, 28mg memantine extended-release, once-daily formulation compared to placebo in outpatients with moderate to severe Alzheimer’s disease currently treated with a cholinesterase inhibitor. The results indicate that patients treated with memantine 28mg extended-release formulation have experienced statistically significant benefits in cognition and clinical global status compared to placebo.
Ivan Gergel, senior vice president of scientific affairs at Forest Laboratories and president of the Forest Research Institute, said: “The higher dosage and once-daily formulation will provide patients with the efficacy and tolerability expected from Namenda (memantine HCl), in a more convenient once-daily form. Based on the results of this study, Forest plans to pursue a new drug application for the memantine extended-release once-daily formulation.”