Less than two weeks after announcing that memantine had shown significant benefit in a clinical trial of patients with moderate to severe Alzheimer's disease ( see news item), Forest Laboratories announced that they have withdrawn their New Drug Application with the FDA.
According to a Forest news release, “Forest will re-file and amend the NDA in order to include important new efficacy and safety data from a recently completed Phase III memantine study and will also correct certain structural and formatting deficiencies identified by the FDA, Division of Neuropharmacological Drug Products."
"The re-filing and the submission of the new study data is expected to be completed by the end of 2002 and will include safety and efficacy data for memantine as monotherapy as well as data for the combination of memantine and donepezil in patients with moderate-to-severe Alzheimer's dementia . . ."—Hakon Heimer