Actavis Launches Combination Drug for Alzheimer’s Disease
Actavis plc has launched Namzaric (memantine hydrochloride extended-release and donepezil hydrochloride), a once-daily, fixed-dose combination of memantine hydrochloride extended-release (a NMDA receptor antagonist), and donepezil hydrochloride (an acetylcholinesterase inhibitor) in the United States. Namzaric was approved by the US Food and Drug Administration in December 2014 for the treatment of moderate to severe Alzheimer’s disease in patients stabilized on memantine hydrochloride and donepezil hydrochloride.
Namzaric will be available in two dosage strengths, 28/10 mg (memantine HCl extended-release/donepezil HCl) and 14/10 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 indicated for the treatment of moderate to severe dementia of the Alzheimer’s type. Donepezil is the active ingredient in Aricept (donepezil hydrochloride), which is indicated 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.