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news.Allergan and Adamas Pharmaceuticals 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).
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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.
Approximately 75% of patients diagnosed with Alzheimer's Disease are in the moderate to severe stage of the disease and yet only about one-third of these patients are treated with combination therapy.
"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.
About the Clinical Trial
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.
The clinical study was not conducted with Namazaric; however, bioequivalence of Namzaric with coadministered memantine HCl extended release and donepezil HCl was demonstrated. Approximately 68% of the patients randomized to receive either memantine HCl extended release 28 mg or placebo were taking donepezil as the AchEI at Baseline and throughout the study.
The results of this study, demonstrated statistically significant improvement in cognition and global function for patients treated with NAMENDA XR (memantine HCl extended release) 28 mg plus an AChEI compared to placebo plus an AchEI at 24 weeks.
About NAMZARIC
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
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. Allergan and Adamas collaborated on the development of the fixed-dose combination and Allergan owns the exclusive U.S. commercialization rights, while Adamas will retain exclusive commercialization rights outside of the U.S.