NAMZARIC™, a once-daily, fixed-dose combination of memantine hydrochloride extended-release + donepezil hydrochloride, is available to patients and healthcare professionals across the United States. NAMZARIC was approved by the U.S. Food and Drug Administration (FDA) in December for the treatment of moderate to severe Alzheimer's disease in patients stabilized on memantine hydrochloride and donepezil hydrochloride.
AdvantagesThe beneifts of Namzaric over current treatments include:
- Extended release formulation: This means that the medication is in a capsule that releases it to the body slowly, over the course of the day. This can sometimes make it easier for the body to absorb, with fewer side effects, and with more consistent results throughout the day.
- One pill: The pill regimen for seniors is often difficult and complex. The fewer pills a person needs to remember to take, and the fewer times per day they need to do so, the better.
- Capsule can be opened: Namzaric comes in an easy-to-open capsule, making it simple to sprinkle the medication over or into food.
Aricept + Namenda (Donepezil+Memantine)Memantine is the generic active ingredient in the currently marketed NAMENDA®, which is indicated for the treatment of moderate to severe dementia of the Alzheimer's type. Donepezil is the active ingredient in ARICEPT®, which is indicated for the treatment of mild to severe dementia of the Alzheimer's type.
|Brand Name||Generic Name||Type|
|Aricept||donepezil||AChEI (Acetylcholinesterase Inhibitor)|
|Namenda||memantine||NMDA Receptor Antagonist|
"Namzaric combines, in one capsule, two complementary therapeutic agents which are often co-prescribed as approximately 70% of Namenda XR patients are also on AChEI therapy. Both Namenda XR and donepezil have proven efficacy and safety, for the treatment of moderate to severe Alzheimer's disease. Additionally, data has shown that combination therapy with Namenda XR and an AChEI demonstrated greater improvement in cognition and global function verses an AChEI alone," said David Nicholson, Actavis Senior Vice President, Global Brands R&D. "Along with our partner Adamas, we are proud that this important therapy will provide a convenient and innovative treatment option for Alzheimer's patients and caregivers that reduces the number of capsules they are required to take each day for the treatment of this devastating disease."
"We are excited about the approval of Namzaric — the first fixed-dose combination of extended-release memantine and donepezil — and look forward to its launch by Actavis in 2015," said Gregory T. Went, Ph.D., Chairman and CEO of Adamas Pharmaceuticals, Inc. "Namzaric is also the first FDA-approved FDC product to emerge from Adamas' platform for modifying the pharmacokinetic profiles of approved drugs, and we look forward to developing additional new treatments for individuals with serious neurological CNS disorders."
Namzaric = Memantine + DonepezilNamzaric, formerly known as MDX-8704, is a once-daily oral capsule for patients currently taking memantine (10 mg twice daily or 28 mg extended-release once-daily) and donepezil 10 mg. In addition, the capsules can be opened to allow the contents to be sprinkled on food to facilitate dosing for patients who may have difficulty swallowing.
"When determining therapies for my patients in the moderate to severe stages of Alzheimer's disease, I consider the therapy's effectiveness, safety profile and its ease of administration. The FDA's approval of Namzaric offers a new therapeutic option that provides patients a fixed-dose combination of two treatments often prescribed together, in one capsule," said Gustavo Alva, MD, Neuropsychiatrist and Medical Director at ATP Clinical Research in Costa Mesa, CA and volunteer faculty member at University of California, Irvine.
Namzaric will be available in two dosage strengths, 28/10 mg (memantine extended release/donepezil) and 14/10mg (memantine extended release/donepezil) for patients with severe renal impairment. 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. Actavis expects to launch Namzaric in the U.S. in the second quarter of 2015.
Results from the Clinical TrialsThe 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 outpatients on a stable dose of AChEIs. The clinical study was not conducted with Namazaric; however, bioequivalence of Namazaric 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 28 mg plus an AChEI compared to placebo plus an AChEI.
The most commonly observed adverse reactions seen with memantine hydrochloride extended-release in patients with moderate to severe Alzheimer's disease, defined as those occurring at a frequency of at least 5% in the memantine hydrochloride extended-release group and at a higher frequency than placebo, were headache, diarrhea, and dizziness.
Convenient Option"We're excited to make once-daily NAMZARIC available as another treatment option for patients with moderate to severe Alzheimer's disease," said Bill Meury, Actavis President, Branded Pharma. "Since the launch of NAMENDA XR® (memantine hydrochloride) in 2013, the two medications, NAMENDA XR and donepezil, have been commonly prescribed in combination with one another to treat the symptoms of moderate to severe Alzheimer's disease. NAMZARIC offers an option with the benefits of both treatments, while reducing the number of pills a patient and their caregivers need to administer each day, to treat this disease."
"We are pleased that NAMZARIC is now available for patients who face the challenges associated with moderate to severe Alzheimer's disease," said Gregory T. Went, Ph.D., Chairman and CEO of Adamas Pharmaceuticals, Inc. "Actavis and Adamas have worked together to create this new fixed-dose combination therapy, the second product from our collaboration. We believe NAMZARIC provides patients and their caregivers with a much needed and more convenient treatment option."
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.