FDA approves new drug to treat dementia.

Actavis and Adamas Pharmaceuticals, Inc., announced that the U.S. Food and Drug Administration has approved the New Drug Application for NamzaricTM for the treatment of moderate to severe dementia of the Alzheimer’s type in patients stabilized on memantine hydrochloride and donepezil hydrochloride. Namzaric will be available in two dosage strengths: 28/10 mg (memantine extended release/donepezil) and 14/10 mg (memantine extended release/donepezil) for patients with severe renal impairment. Efficacy and safety of the coadministration of memantine hydrochloride (HCl) extended release and acetylcholinesterase inhibitors (AChEIs), including donepezil HCl, was based on the results of a randomized, double-blind, placebocontrolled trial of 677 outpatients on a stable dose of AChEIs. The clinical study was not conducted with Namzaric; however, bioequivalence of Namzaric with coadministered memantine HCl extended release and donepezil HCl was demonstrated. Approximately 68% of patients randomized to receive either memantine HCl extended release 28 mg or a placebo were taking donepezil as the AChEI at baseline and throughout the study. The results demonstrated statistically significant improvement in cognition and global function for patients treated with memantine HCl 28 mg plus an AChEI compared to the placebo plus an AChEI. Source. “Actavis and Adamas Announce FDA Approval of NamzaricTM, a Fixed-Dose Combination of Memantine Extended-Release and Donepezil Hydrochloride.” (2014, December 24). Retrieved February 3, 2015, from http:// prn.to/1uUGmCK.