FDA Approves New Combination Alzheimer's Drug

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The FDA has approved a new drug for the treatment of moderate to severe Alzheimer’s disease that combines in a single capsule two medications already on the market for the disease, memantine (Namenda)  and donepezil (Aricept).

Namzaric is a fixed-dose combination of memantine extended-release and donepezil. The new drug will be available in two dosage strengths: 28/10 mg (memantine extended release/donepezil) and 14/10mg (memantine extended release/donepezil). Actavis, which has U.S. commercialization rights, plans to launch Namzaric in the second quarter of 2015. Outside the U.S., the drug will be marketed by Adamas Pharmaceuticals.

The capsules can also be opened to allow the medication to be sprinkled on food to facilitate dosing for patients who may have difficulty swallowing.

"Namzaric combines, in one capsule, two complementary therapeutic agents which are often co-prescribed as approximately 70% of Namenda XR patients are also on [acetylcholinesterase inhibitor (AChEI)] therapy,” David Nicholson, Actavis Senior Vice President, Global Brands R&D, said in a statement. “Additionally, data has shown that combination therapy with Namenda XR and an AChEI demonstrated greater improvement in cognition and global function versus an AChEI alone.”

Memantine is a NMDA receptor antagonist, while donepezil is an AChEI.

FDA Approves New Combination Alzheimer's Drug
FDA Approves New Combination Alzheimer's Drug

Actavis and Adamas Pharmaceuticals announced that the U.S. Food and Drug Administration (FDA) has approved the New Drug Application (NDA) for Namzaric, a fixed-dose combination (FDC) of memantine hydrochloride extended-release, a 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.
 

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