Allergan plc and Adamas Pharmaceuticals, Inc. announced that the U.S. Food and Drug Administration (FDA) has approved a new, expanded label for NAMZARIC® (memantine and donepezil hydrochlorides) extended-release, a once-daily, fixed-dose combination of memantine hydrochloride (a NMDA receptor antagonist) and donepezil hydrochloride (an acetylcholinesterase inhibitor, AChEI).
With the new indication, patients with moderate to severe Alzheimer's disease, who are currently stabilized on Aricept, donepezil hydrochloride (10 mg), can now start combination therapy directly with NAMZARIC.
"Clinical studies have shown that combination therapy with Namenda XR and an AChEI such as Aricept demonstrated greater improvement in cognition and global function verses an AChEI alone. NAMZARIC offers the benefits of combining two products that each work differently to treat moderate to severe Alzheimer's disease while at the same time reducing the number of pills a patient and their caregivers need to administer each day," says Gavin Corcoran, M.D., chief medical officer at Allergan. "At Allergan, we're proud to continue developing products and supporting new programs that can help patients and their caregivers as they navigate this complex disease."
With the new, expanded indication, NAMZARIC will be available in four dosage strengths which allows patients currently taking Aricept 10mg to start on NAMZARIC the very next day. Namzaric is covered broadly by Medicare Part D prescription plans.
In addition to the two currently available dosage strengths, the two new NAMZARIC dosage strengths will be available in pharmacies in September.
The efficacy and safety of the coadministration of memantine HCl extended release and acetylcholinesterase inhibitors (AChEIs), including donepezil HCl, was based on the results of a randomized, double-blind, placebo-controlled trial of 677 patients with moderate to severe Alzheimer's Disease on a stable dose of AChEIs.
NAMZARIC is a once-daily, fixed-dose combination of memantine hydrochloride, a NMDA receptor antagonist, and donepezil hydrochloride, an acetylcholinesterase inhibitor indicated for the treatment of moderate to severe dementia of the Alzheimer's type in patients stabilized on 10 mg of donepezil HCl once daily
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