Actavis, Adamas Pharmaceuticals Win FDA Approval for Alzheimer's Drug Namzaric

Actavis, Adamas Pharmaceuticals Win FDA Approval for Alzheimer's Drug Namzaric
December 24, 2014
By Krystle Vermes, BioSpace.com Breaking News Staff

Actavis plc and Adamas Pharmaceuticals Inc. , announced today that the U.S. Food and Drug Administration has approved of the New Drug Application for Namzaric, a treatment for moderate to severe dementia and Alzheimer’s disease.

Namzaric is a fixed-dose combination of memantine hydrochloride, an NMDA receptor antagonist, and donepezil hydrochloride, an acetylcholinesterase inhibitor. In testing, the drug was formally known as MDX-8704. Namzaric is designed to be given once a day to patients currently taking memantine and donepezil.

"Namzaric combines, in one capsule, two complementary therapeutic agents which are often co-prescribed as approximately 70 percent of Namenda XR patients are also on AChEI therapy,” said David Nicholson, Actavis senior vice president of global brands research and development. “Both Namenda XR and donepezil have proven efficacy and safety, for the treatment of moderate to severe Alzheimer's disease. Additionally, data has shown that combination therapy with Namenda XR and an AChEI demonstrated greater improvement in cognition and global function verses an AChEI alone.”

Namzaric will be available in two dosage strengths, 28/10mg and 14/10mg. Memantine ER, the active ingredient the drug, is currently marketed as NAMENDA XR. It is indicated for the treatment of dementia and Alzheimer’s disease in patients.

"We are excited about the approval of Namzaric the first fixed-dose combination of extended-release memantine and donepezil and look forward to its launch by Actavis in 2015," said Gregory Went, chairman and CEO of Adamas Pharmaceuticals, Inc. "Namzaric is also the first FDA-approved FDC product to emerge from Adamas' platform for modifying the pharmacokinetic profiles of approved drugs, and we look forward to developing additional new treatments for individuals with serious neurological CNS disorders."

In many cases, physicians prescribe NAMENDA XR in addition to AChEI to patients who are facing Alzheimer’s disease, viewing these two treatments as an effective way to address the condition as a whole.

An acetylcholinesterase inhibitor, or AChEI, is thought to slow the breakdown of a chemical in the brain that is involved in learning and memory, known as acetylcholine. NAMENDA XR can be added to a treatment plan to address the breakdown of glutamate, another chemical in the brain responsible for learning and memory. Together, these two drugs may improve the quality of life for Alzheimer’s patients.

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