Actavis Says NAMZARIC Available Across U.S. - Quick Facts

(RTTNews) - Actavis plc (ACT) said Monday that 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), is now available to patients and healthcare professionals across the United States.

NAMZARIC was approved by the U.S. Food and Drug Administration or 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 will be available in two dosage strengths, 28/10 mg (memantine HCl extended-release/donepezil HCl) and 14/10mg (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 U.S. commercialization rights, while Adamas will retain exclusive commercialization rights outside of the U.S.