Forest Laboratories to continue development of Alzheimer’s drug

The 24-week trial was a double-blind, randomized, placebo-controlled trial conducted at 47 US study sites, evaluating 198 patients out of an originally-planned 400 patients who were suffering from moderate-to-severe Alzheimer’s disease and who were not receiving any other treatments for their dementia.

Patients on neramexane showed statistically significant improvement versus placebo-treated patients. While the difference on the SIB was not significant at week 24, data from assessments at week 12 showed a significant difference in favor of neramexane, with a strong trend in favor of neramexane at week 18 as well. The adverse event profile of neramexane in this study was comparable to placebo.

“We are pleased with the results of this study,” said Dr Ivan Gergel, senior vice president of scientific affairs and president of the Forest Research Institute. “Even though recruitment of patients into this study was stopped early due to slow patient enrollment, the neramexane treatment group actually achieved statistical significance on scales assessing activities of daily living and exhibited strong trends in favor of neramexane on measures of cognition.”

Neramexane is being developed jointly by Forest and its licensor, Merz Pharmaceuticals. Neramexane, and Forest’s Namenda (memantine HCl), belongs to a new class of drugs for Alzheimer’s disease called NMDA (N-methyl-D-aspartate) receptor antagonists. While neramexane’s mechanism of action is similar to that of Namenda, neramexane is a distinct chemical entity.