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Alzheimer’s Drug Namzaric (Memantine/Donepezil) Wins FDA Nod

Launch expected in second quarter of 2015

The FDA has approved the new drug application for Namzaric (Actavis/Adamas Pharmaceuticals), a fixed-dose combination of extended-release memantine hydrochloride, an N-methyl-D-aspartate (NMDA) receptor antagonist, and donepezil hydrochloride, an acetylcholinesterase inhibitor.

Namzaric was approved for the treatment of moderate-to-severe dementia of the Alzheimer’s type in patients stabilized on memantine hydrochloride and donepezil hydrochloride.

Namzaric, formerly known as MDX-8704, is a once-daily oral capsule for patients currently taking memantine (10 mg twice daily or 28 mg extended-release once-daily) and donepezil 10 mg. In addition, the capsules can be opened to allow the contents to be sprinkled on food to facilitate dosing for patients who may have difficulty swallowing.

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.

Extended-release memantine is the active ingredient in Namenda XR (Forest Pharmaceuticals), which is indicated for the treatment of moderate-to-severe dementia of the Alzheimer’s type. Donepezil is the active ingredient in Aricept (Eisai/Pfizer), which is indicated for the treatment of mild-to-severe dementia of the Alzheimer’s type.

 Namzaric is expected to be launched in the U.S. in the second quarter of 2015.

The efficacy and safety of the co-administration of extended-release memantine and acetylcholinesterase inhibitors (AChEIs), including donepezil, were based on the results of a randomized, double-blind, placebo-controlled study of 677 outpatients receiving a stable dose of AChEIs. This clinical study was not conducted with Namazaric; however, the bioequivalence of Namazaric with co-administered extended-release memantine and donepezil was demonstrated. Approximately 68% of the patients randomly assigned to receive either extended-release memantine 28 mg or placebo were taking donepezil as the AchEI at baseline and throughout the study. The results of this study demonstrated statistically significant improvement in cognition and global function for patients treated with Namenda XR 28 mg plus an AChEI compared with placebo plus an AChEI.

The most common adverse events associated with extended-release memantine in patients with moderate-to-severe Alzheimer’s disease include headache, diarrhea, and dizziness.

An estimated 5.2 million people in the U.S. have Alzheimer’s disease (AD), which is the fifth leading cause of death in the U.S. among individuals 65 years of age or older. AD was reported as an underlying cause of death in more than 83,000 Americans in 2010.

Source: Actavis; December 24, 2014.

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