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Actavis launch Namzaric, once-daily FDC therapy, in US market to treat Alzheimer's disease

 

Clinical courses

Actavis plc has introduced Namzaric, a once-daily, fixed-dose combination of memantine hydrochloride extended-release (a NMDA receptor antagonist), and donepezil hydrochloride (an acetylcholinesterase inhibitor) across the United States. Namzaric was approved by the US Food and Drug Administration (FDA) in December for the treatment of moderate to severe Alzheimer's disease in patients stabilized on memantine hydrochloride and donepezil hydrochloride.

Namzaric is a once-daily, fixed-dose combination of memantine hydrochloride extended-release, a NMDA receptor antagonist, and donepezil hydrochloride, an acetylcholinesterase inhibitor. Namzaric available in two dosage strength 14/10mg (memantine HCl extended-release/donepezil HCl) and 28/10 mg (memantine HCl extended-release/donepezil HCl)for patients with severe renal impairment.

Memantine hydrochloride extended-release is the active ingredient in the currently marketed Namenda XR, which is used for the treatment of moderate to severe dementia of the Alzheimer's type. Donepezil is the active ingredient in Aricept (donepezil hydrochloride), used 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 and Actavis will have exclusive US commercialization rights, while Adamas will retain exclusive commercialization rights outside of the US.


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