FDA Approves Namzaric to Treat Alzheimer's Disease

The FDA has approved Namzaric, a fixed-dose combination of memantine hydrochloride extended-release (ER), an N-methyl D-aspartate receptor antagonist, and donepezil hydrochloride, an acetylcholinesterase inhibitor (AChEI).

Actavis and Adamas Pharmaceuticals’ Namzaric will be used for the treatment of moderate to severe dementia related to Alzheimer’s disease among patients stabilized on memantine hydrochloride and donepezil hydrochloride.

Namzaric will be available in 2 strengths, 28/10 mg (memantine ER/donepezil) and 14/10 mg (memantine ER/donepezil) for patients with severe renal impairment. In the past, patients have often been prescribed Namenda XR and Aricept to help fight dementia, but this therapy combines the 2 into 1 capsule. Namenda XR uses memantine ER as its active ingredient to treat moderate to severe dementia of the Alzheimer’s type, while Aricept uses donepezil.

The new drug will be available as a once-daily oral capsule, which can be opened and sprinkled on food so that patients who have difficulty swallowing can ingest the drug more easily.

According to the manufacturers, a study showed statistically significant improvement in cognition and global function among patients taking Namenda XR 28 mg plus an AChEI such as donepezil HCL, compared with placebo plus an AChEI.

“Along with our partner Adamas, we are proud that this important therapy will provide a convenient and innovative treatment option for Alzheimer’s patients and caregivers that reduces the number of capsules they are required to take each day for the treatment of this devastating disease,” said David Nicholson, Actavis’s senior vice president, global brands research and development, in a press release.