FDA approves once daily Namzaric for treatment of Alzheimer's

Allergan plc and Adamas Pharmaceuticals Inc. recently announced the U.S. Food and Drug Administration's approval of Namzaric (memantine and donepezil hydrochlorides) for treatment of moderate to severe Alzheimer's Disease. 

With the FDA's approval, extended-release, once-daily Namzaric can now be used in combination with Aricept.

The clinical trial of a Namzaric bioequivalent showed that the participants who received Namenda XR plus a acetylcholinesterase inhibitor (AChEI), such as Aricept, responded with improved cognition and overall function. The randomized 677 participants received Namenda XR plus AChEI or a placebo plus AChEI.

"Clinical studies have shown that combination therapy with Namenda XR and an AChEI such as Aricept demonstrated greater improvement in cognition and global function verses an AChEI alone," Allergan Chief Medical Officer Dr. Gavin Corcoran said. "Namzaric offers the benefits of combining two products that each work differently to treat moderate to severe Alzheimer's disease while at the same time reducing the number of pills a patient and their caregivers need to administer each day. At Allergan, we're proud to continue developing products and supporting new programs that can help patients and their caregivers as they navigate this complex disease."

Namzaric will be available in four strengths. Patients that are currently stabilized on Aricept 10 mg can start taking Namzaric immediately. Many Medicare Part D prescription plans include Namzaric in their formularies.

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Organizations in this story

Adamas Pharmaceuticals, Inc. 1900 Powell St Emeryville, CA - 94608