Combo Pill for Alzheimer’s Disease: FDA Signs off


More than half of nursing home residents with advanced dementia receive medications of “questionable” benefit, including cholinesterase inhibitors, typically given during earlier stages of dementia, and statins to lower cholesterol.

Now there’s something new to consider…

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

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“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.

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

“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.

Namzaric offers a new therapeutic option that provides patients in the moderate to severe stages of Alzheimer’s disease a fixed-dose combination of two treatments often prescribed together, in one capsule.

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About Elder Care Advice blog

Get professional elder care giving advice, advocacy, education and tips for those who care for and about the frail elderly at the ElderCareAdvice blog. We are generously sponsored by CertifiedCare.org. Most posts are written by Cathleen V. Carr, unless attributed otherwise. We welcome relevant submissions. Submit your article and by-line for publishing consideration (no promises!) to Havi at zvardit@yahoo.com, our own editor who will ensure submissions are given the best possible treatment and polish before publication, ensuring a professional level of publication. There is a nominal service fee involved ($45). Allow up to 30 days for publishing.
This entry was posted in Alzheimer's Caregiving, Dementia Caregiving, Government, News, Professional Eldercare and tagged , , , , , , . Bookmark the permalink.

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