FDA approves new Alzheimer’s drug

December 30, 2014

FDA approved the New Drug Application (NDA) for a new treatment for moderate to severe dementia in Alzheimer’s patients.

FDA approved the New Drug Application (NDA) for a new treatment for moderate to severe dementia in Alzheimer’s patients.

Namzaric, a fixed-dose combination (FDC) of memantine hydrochloride extended-release, a NMDA receptor antagonist, and donepezil hydrochloride, an acetylcholinesterase inhibitor, is manufacture red by Actavis plc and Adamas Pharmaceuticals Inc.

"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, senior vice president of Global Brands R&D at Actavis, in a press release.

"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. Both Namenda XR and donepezil have proven efficacy and safety for the treatment of moderate to severe Alzheimer's disease,” Nicholson added. Data has shown that combination therapy with Namenda XR and an AChEI demonstrated greater improvement in cognition and global function verses an AChEI alone.

Actavis expects to launch Namzaric in the United States in the second quarter of 2015.

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Namzaric 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 have difficulty swallowing.

Namzaric will be available in 2 dosage strengths: 28/10 mg (memantine extended release/donepezil) and 14/10mg (memantine extended release/donepezil) for patients with severe renal impairment.

Memantine ER is the active ingredient in the currently marketed Namenda XR, which is indicated for the treatment of moderate to severe dementia of the Alzheimer's type. Donepezil is the active ingredient in Aricept, which is indicated for the treatment of mild to severe dementia of the Alzheimer's type.