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Forest Laboratories, Inc. Announces Positive Results of Memantine Study of Once-Daily Formulation
Date:2/5/2008

NEW YORK, Feb. 5 /PRNewswire-FirstCall/ -- Forest Laboratories, Inc. (NYSE: FRX) today announced preliminary results of a Phase III study of memantine HCl (currently marketed as Namenda(R), a twice-daily immediate- release formulation) in a novel once-daily formulation. The study evaluated the efficacy, safety, and tolerability of an innovative, proprietary, 28 mg 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 28 mg extended-release formulation experienced statistically significant benefits in cognition and clinical global status compared to placebo. Additional data from the study are expected to be presented later in the year.

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The recommended dose for Namenda is currently 10 mg two times a day (20 mg/day), or for patients with severe renal impairment 5 mg twice a day (10 mg/day). Patients in this study were titrated to 28 mg/day in a once-daily modified release formulation. Namenda is currently available in tablets or liquid form.

"The higher dosage and once-daily formulation will provide patients with the efficacy and tolerability expected from Namenda, in a more convenient once-daily form," said Ivan Gergel, M.D., Senior Vice President of Scientific Affairs at Forest Laboratories and President of the Forest Research Institute. "Based on the results of this study, Forest plans to pursue a new drug application for the memantine extended-release once-daily formulation."

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