Actavis and Adamas announced that the Food and Drug Administration (FDA) has approved the New Drug Application (NDA) for Namzaric (memantine HCl extended-release and donepezil HCl) capsules for the treatment of moderate to severe Alzheimer’s dementia in patients stabilized on memantine HCl and donepezil HCl. Namzaric is the first fixed-dose combination of memantine extended-release and donepezil.
Namzaric combines memantine HCl, an NMDA receptor antagonist, and donepezil HCl, an acetylcholinesterase inhibitor. Memantine HCl extended-release is currently marketed as Namenda XR and donepezil HCl is currently marketed as Aricept. Clinical study data have shown that combination therapy with memantine HCl and an acetylcholinesterase inhibitor have resulted in increased improvement in cognition and global function vs. an acetylcholinesterase inhibitor alone.
Namzaric capsules will be available in 28mg/10mg and 14mg/10mg strengths. Namzaric is expected to launch in the second quarter of 2015.