Namzaric (memantine hydrochloride extended-release + donepezil hydrochloride)

The following drug information is obtained from various newswires, published medical journal articles, and medical conference presentations.

Approval Status:

Approved December 2014

Specific Treatments:

moderate to severe dementia of the Alzheimer's type

Therapeutic Areas

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General Information

Namzaric is a fixed-dose combination of memantine hydrochloride extended-release, a NMDA receptor antagonist, and donepezil hydrochloride, an acetylcholinesterase inhibitor.

Namzaric is specifically indicated for the treatment of moderate to severe dementia of the Alzheimer's type in patients stabilized on memantine hydrochloride and donepezil hydrochloride.

Namzaric is supplied as a capsule for once daily oral administration. The capsules can also be opened to allow the contents to be sprinkled on food to facilitate dosing for patients who may have difficulty swallowing.

Clinical Results

FDA Approval

The FDA approval of Namzaric was based on the results of a randomized, double-blind, placebo-controlled trial of 677 outpatients on a stable dose of acetylcholinesterase inhibitors (AChEIs). The clinical study was not conducted with Namazaric; however, bioequivalence of Namazaric with coadministered memantine HCl extended release and donepezil HCl was demonstrated. Approximately 68% of the patients randomized to receive either memantine HCl extended release 28 mg or 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 Namenda XR 28 mg plus an AChEI compared to placebo plus an AChEI.

Side Effects

Adverse effects associated with the use of Namzaric may include, but are not limited to, the following:

  • headache
  • diarrhea
  • dizziness

Mechanism of Action

Namzaric is a fixed-dose combination of memantine hydrochloride extended-release, a NMDA receptor antagonist, and donepezil hydrochloride, an acetylcholinesterase inhibitor.

Additional Information

For additional information regarding Namzaric or dementia and Alzheimer's disease, please visit http://www.actavis.com/