NDA for Alzheimer’s Combined Drug Namzaric Approved by FDA

Actavis and Adamas Pharmaceuticals Inc. announced that the US Food and Drug Administration has accepted Namzaric‘s New Drug Application (NDA) as a fixed-dose combination of memantine hydrochloride extended-release, a NMDA receptor antagonist, and donepezil hydrochloride, an acetylcholinesterase inhibitor, for the treatment of moderate to severe Alzheimer’s Disease in patients stabilized on memantine hydrochloride and donepezil hydrochloride. Namzaric, is also known as MDX-8704. In cases of known difficulty in swallowing, the drug may be sprinkled and mixed in the patient’s food.

“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.  Both Namenda XR and donepezil have proven efficacy and safety, for the treatment of moderate/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. 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,” explained Actavis’s Senior Vice President, David Nicholson, in a press release.

Gregory T. Went, the CEO of Adamas Pharmaceuticals said: “We are excited about the approval of Namzaric — the first fixed-dose combination of extended-release memantine and donepezil — and look forward to its launch by Actavis in 2015. Namzaric is also the first FDA-approved FDC product to emerge from Adamas’ platform for modifying the pharmacokinetic profiles of approved drugs, and we look forward to developing additional new treatments for individuals with serious neurological CNS disorders.”

Gustavo Alva, Medical Director at ATP Clinical Research in Costa Mesa, CA and faculty member at University of California, Irvine added: “When determining therapies for my patients in the moderate/severe stages of Alzheimer’s disease, I consider the therapy’s effectiveness, safety profile and its ease of administration. 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.”

Two dosages of Namzaric will be available, with one specially formulated for those with renal impairment. Memantine ER is currently marketed under the name Namenda XR® and it is used to treat moderate/severe Alzheimer’s. Donepezil, sold under Aricept® is used to treat mild/severe Alzheimer’s. Actavis and Adamas teamed up to develop a fixed dose combination. Actavis will own exclusive commercialization rights regarding the U.S., and Adamas will own those same rights outside the U.S.

Actavis expects to make Namzaric commercially available in the U.S. in Q2 2015.