FDA Approves Namzaric for Alzheimer's Disease

By Megan Brooks
WebMD Health News

Reviewed By Michael W. Smith, MD

The US Food and Drug Administration (FDA) has approved a fixed-dose combination of memantine hydrochloride extended-release (XR) and donepezil hydrochloride (Namzaric, Actavis plc/Adamas Pharm) for moderate to severe Alzheimer's-related dementia in patients receiving stable doses of the two drugs.

Memantine XR (Namenda XR, Actavis) is an N-methyl-D-aspartate inhibitor, and donepezil (Aricept, Pfizer) is an acetylcholinesterase inhibitor (AChEI).

"Namzaric combines, in one capsule, two complementary therapeutic agents which are often co-prescribed as approximately 70% of Namenda XR patients are also on AChEI therapy," David Nicholson, Actavis senior vice president, global brands R&D, noted in a news release.

"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," Nicholson said.

Namzaric (formerly MDX-8704) is a once-daily capsule for patients currently taking memantine (10 mg twice daily or 28 mg XR once-daily) plus donepezil 10 mg. The capsules can be opened and sprinkled on food for patients who have difficulty swallowing.

Namzaric will be available in two strengths: 28/10 mg (memantine/donepezil) and 14/10 mg (memantine/donepezil) for patients with severe renal impairment.

"When determining therapies for my patients in the moderate to severe stages of Alzheimer's disease, I consider the therapy's effectiveness, safety profile and its ease of administration," Gustavo Alva, MD, neuropsychiatrist and medical director at ATP Clinical Research in Costa Mesa, California, and volunteer faculty member at University of California, Irvine, said in the news release.

"The FDA's approval of Namzaric offers a new therapeutic option that provides patients a fixed-dose combination of two treatments often prescribed together, in one capsule," he added.


Dementia, Alzheimer's Disease, and Aging Brains See Slideshow

FDA OKs Memantine/Donepezil (Namzaric) Combo Pill for Alzheimer's Disease. Medscape. Dec 26, 2014.

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