Forest announces positive results for once-daily Alzheimer’s drug

Forest Laboratories has reported preliminary results of its phase III study of Namenda (memantine HCl) in a new once-daily formulation.

The study investigated the efficacy, safety and tolerability profile of a 28mg dosage in outpatients with moderate to severe Alzheimer’s disease currently treated with a cholinesterase inhibitor.

Study data found that patients treated with memantine 28mg extended-release formulation experienced statistically significant benefits in cognition and clinical global status compared to placebo.

Currently, the recommended dose for Namenda is ten mg twice-daily (or five mg twice-daily for patients with severe renal impairment).

Ivan Gergel, senior vice-president of scientific affairs at Forest Laboratories and president of the Forest Research Institute, indicated that the higher dosage and once-daily formulation of Namenda would provide patents with the efficacy and tolerability expected with added convenience.

He added: “Based on the results of this study, Forest plans to pursue a new drug application for the memantine extended-release.”

Earlier this month, Forest Laboratories and Cypress Bioscience submitted a New Drug Application (NDA) to the US Food and Drug Administration for its dual-reuptake inhibitor milnacipran in the treatment of fibromyalgia syndrome.