Forest Laboratories, Inc. announced that results of a US Phase III study of Namenda (memantine HCl) as monotherapy in mild to moderate Alzheimer's disease show the drug demonstrated a statistically significant difference versus placebo with respect to the study's primary efficacy measures of cognition and global outcome. Results from a similar study conducted by H Lundbeck in Europe showed significance at some interim time points, but not at the study's conclusion. Forest plans to seek approval for a mild to moderate indication based on the positive outcome of the US study.
"We are encouraged by the positive results that indicate treatment with Namenda is associated with efficacy and tolerability among patients with mild to moderate Alzheimer's disease," said Lawrence Olanoff, MD, PhD, executive vice president, Forest Laboratories, Inc. "Based on this positive preliminary analysis of the US study, Forest plans to file a supplemental New Drug Application for Namenda as a treatment for mild to moderate Alzheimer's disease in mid-2004."
The double-blind, parallel group, placebo-controlled Phase III studies were designed to evaluate the safety and efficacy of Namenda given as monotherapy at a daily dosage of 10 mg twice a day to patients with mild to moderate Alzheimer's disease over a period of 6 months. The US study was conducted at 42 centres and included 403 patients with mild to moderate Alzheimer's disease while the European study was conducted at 65 centres and included 470 patients.
Results from the US study show that patients receiving Namenda performed significantly better than patients receiving placebo on both primary outcome measures; the Alzheimer's Disease Assessment Scale - cognitive subscale (ADAS- cog) (p=0.003) a measure of cognitive function, and the Clinician's Interview Based Impression of Change - Plus version (CIBIC-plus), a global measure of overall status (p=0.004). Namenda was well tolerated in the study and Namenda patients experienced adverse events at overall rates that were comparable to patients on placebo.
In the European trial, in the prospectively defined primary analysis, the difference in values for the primary endpoints, the ADAS-cog and the CIBIC- plus, between the two groups was statistically significant in favour of the memantine treatment group versus the placebo group at multiple time points, while at week 24, although numerical improvement was observed, statistical significance was not reached due to a higher than expected response in the placebo group. As in the US trial, adverse-event rates overall were similar for the two treatment groups.
"The results of these studies represent an important step forward for all patients, caregivers, and physicians who deal with this devastating illness on a daily basis," said Howard Solomon, chairman and CEO of Forest Laboratories, Inc. "In the future, it is our hope that Namenda will be approved for all stages of Alzheimer's disease."