DUBLIN, Ireland, and EMERYVILLE, Calif. — Actavis plc and Adamas Pharmaceuticals Inc. have received approval from the Food and Drug Administration for Namzaric, a fixed-dose combination medication for Alzheimer’s disease.
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. The capsules also can be opened to allow the contents to be sprinkled on food to facilitate dosing for patients with difficulty swallowing.
The combination drug is indicated for the treatment of moderate to severe dementia of the Alzheimer’s type in patients stabilized on memantine hydrochloride and donepezil hydrochloride.
"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 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," stated David Nicholson, senior vice president of global brands R&D at Actavis. "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."
Namzaric will come in two 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, for the treatment of moderate to severe dementia of the Alzheimer’s type. Donepezil is the active ingredient in Aricept, for the treatment of mild to severe dementia of the Alzheimer’s type.
Actavis and Adamas collaborated on the development of the fixed-dose combination. Actavis will have exclusive U.S. commercialization rights, while Adamas will retain exclusive commercialization rights outside the United States.
Actavis plans to launch Namzaric in the United States in the second quarter of 2015.
"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," commented Gregory Went, chairman and chief executive officer of Adamas. "Namzaric is also the first FDA-approved fixed-dose combination 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 [central nervous system] disorders."
