Forest Laboratories Inc. filed a new drug application for memantine, an investigational Alzheimer's agent for the treatment of moderate to severe disease.
The FDA has 60 days to decide whether it will accept the new and amended application for filing, Forest said. The new and amended version corrects minor structural and formatting deficiencies identified by the agency in the previous application, submitted in July.
Forest's partners in the development in the project are Neurobiological Technologies Inc., of Richmond, Calif., and Merz Pharmaceuticals GmbH, of Frankfurt, Germany.
Ronny Kraft, a spokesman for Neurobiological Technologies, described memantine's benefits, saying, "Basically, memantine allows patients to feed themselves for an extended period of time, to hold on to their faculties for a longer period of time than they previously were able to."
Forest, of New York, filed the NDA July 31, but voluntarily withdrew it Sept. 23 in order to make certain corrections and to include new efficacy and safety data from another Phase III trial.
Memantine is a moderate-affinity, uncompetitive N-methyl D-aspartate receptor antagonist that modulates glutamate levels.
According to the company, in clinical trials memantine was well tolerated with overall adverse events comparable in incidence to placebo.
Forest will amend the NDA by the end of January with data from a double-blind, parallel-arm, placebo-controlled study of more than 400 patients with moderate to severe disease. The company said patients who received the combination of memantine and donepezil (Aricept) performed significantly better than patients on donepezil and placebo.