New Combination Drug For Alzheimer's Patients Wins Fda Approval
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Namzaric, formerly known every bit MDX-8704, is a once-daily oral capsule for patients currently taking memantine (10 mg twice daily or 28 mg extended-release once-daily) in addition to donepezil 10 mg.
Actavis plc (ACT) in addition to Adamas Pharmaceuticals Inc. (ADMS) today announced that the USA Food in addition to Drug Administration (FDA) has approved the New Drug Application (NDA) for Namzaric, a fixed-dose combination (FDC) of memantine hydrochloride extended-release, a NMDA receptor antagonist, in addition to donepezil hydrochloride, an acetylcholinesterase inhibitor.
Namzaric was approved for the handling of moderate to severe dementia of the Alzheimer's type inwards patients stabilized on memantine hydrochloride in addition to donepezil hydrochloride.
Namzaric, formerly known every bit MDX-8704, is a once-daily oral capsule for patients currently taking memantine (10 mg twice daily or 28 mg extended-release once-daily) in addition to donepezil 10 mg. In addition, the capsules tin flaming hold out opened to let the contents to hold out sprinkled on nutrient to facilitate dosing for patients who may stimulate got difficulty swallowing.
Memantine ER is the active element inwards the currently marketed NAMENDA XR®, which is indicated for the handling of moderate to severe dementia of the Alzheimer's type.
Donepezil is the active element inwards ARICEPT®, which is indicated for the handling of mild to severe dementia of the Alzheimer's type. Actavis in addition to Adamas collaborated on the evolution of the fixed-dose combination.
Actavis volition stimulate got exclusive USA commercialization rights, spell Adamas volition retain exclusive commercialization rights exterior of the U.S.
Actavis expects to launch Namzaric inwards the USA inwards the instant quarter of 2015.
About the Clinical Trials
The efficacy in addition to security of the coadministration of memantine HCl extended unloose in addition to acetylcholinesterase inhibitors (AChEIs), including donepezil HCl, was based on the results of a randomized, double-blind, placebo-controlled case of 677 outpatients on a stable dose of AChEIs.
The clinical written report was non conducted amongst Namazaric; however, bioequivalence of Namazaric amongst coadministered memantine HCl extended unloose in addition to donepezil HCl was demonstrated.
Approximately 68% of the patients randomized to have either memantine HCl extended unloose 28 mg or placebo were taking donepezil every bit the AchEI at Baseline in addition to throughout the study. The results of this study, demonstrated statistically pregnant improvement inwards knowledge in addition to global component for patients treated amongst NAMENDA XR 28 mg plus an AChEI compared to placebo plus an AChEI.
The most ordinarily observed adverse reactions seen amongst memantine hydrochloride extended-release inwards patients amongst moderate to severe Alzheimer's disease, defined every bit those occurring at a frequency of at to the lowest degree 5% inwards the memantine hydrochloride extended-release grouping in addition to at a higher frequency than placebo, were headache, diarrhea, in addition to dizziness.
About Adamas Pharmaceuticals
Adamas Pharmaceuticals, Inc. is a specialty pharmaceutical companionship driven to amend the lives of those affected past times chronic disorders of the primal nervous system. The companionship achieves this past times modifying the pharmacokinetic profiles of approved drugs to practise novel therapeutics for role lone or inwards fixed-dose combination products.
For to a greater extent than information, catch Adamas at http://adamaspharma.com/
About Actavis
Actavis plc (ACT), headquartered inwards Dublin, Ireland, is a unique specialty pharmaceutical companionship focused on developing, manufacturing in addition to commercializing high character affordable generic in addition to innovative branded pharmaceutical products for patients about the world.
For to a greater extent than information, catch Actavis at www.actavis.com.
More Articles on Alzheimer's in addition to Dementia
The USA Food in addition to Drug Administration (FDA) has approved the New Drug Application (NDA) for Namzaric, a fixed-dose combination (FDC) of memantine in addition to donepezil. Namzaric was approved for the handling of moderate to severe dementia of the Alzheimer's type inwards patients stabilized on Namenda in addition to donepezil (formerly branded every bit Aricept).
Namzaric, formerly known every bit MDX-8704, is a once-daily oral capsule for patients currently taking memantine (10 mg twice daily or 28 mg extended-release once-daily) in addition to donepezil 10 mg.
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Actavis plc (ACT) in addition to Adamas Pharmaceuticals Inc. (ADMS) today announced that the USA Food in addition to Drug Administration (FDA) has approved the New Drug Application (NDA) for Namzaric, a fixed-dose combination (FDC) of memantine hydrochloride extended-release, a NMDA receptor antagonist, in addition to donepezil hydrochloride, an acetylcholinesterase inhibitor.
Combination Therapy for Alzheimer's Disease (Aricept in addition to Namenda)
Namzaric was approved for the handling of moderate to severe dementia of the Alzheimer's type inwards patients stabilized on memantine hydrochloride in addition to donepezil hydrochloride.
"Namzaric combines, inwards 1 capsule, ii complementary therapeutic agents which are oftentimes co-prescribed every bit closed to 70% of Namenda XR patients are besides on AChEI therapy. Both Namenda XR in addition to donepezil stimulate got proven efficacy in addition to safety, for the handling of moderate to severe Alzheimer's disease. Additionally, information has shown that combination therapy amongst Namenda XR in addition to an AChEI demonstrated greater improvement inwards knowledge in addition to global component verses an AChEI alone," said David Nicholson, Actavis Senior Vice President, Global Brands R&D.
"Along amongst our partner Adamas, nosotros are proud that this of import therapy volition supply a convenient in addition to innovative handling alternative for Alzheimer's patients in addition to caregivers that reduces the publish of capsules they are required to stimulate got each solar daytime for the handling of this devastating disease.
"We are excited close the blessing of Namzaric — the starting fourth dimension fixed-dose combination of extended-release memantine in addition to donepezil — in addition to aspect forrad to its launch past times Actavis inwards 2015," said Gregory T. Went, Ph.D., Chairman in addition to CEO of Adamas Pharmaceuticals, Inc. "Namzaric is besides the starting fourth dimension FDA-approved FDC production to emerge from Adamas' platform for modifying the pharmacokinetic profiles of approved drugs, in addition to nosotros aspect forrad to developing additional novel treatments for individuals amongst serious neurological CNS disorders."
Does the Combination of Aricept in addition to Namenda Slow the Rate of Decline inwards Alzheimer's Patients
Namzaric, formerly known every bit MDX-8704, is a once-daily oral capsule for patients currently taking memantine (10 mg twice daily or 28 mg extended-release once-daily) in addition to donepezil 10 mg. In addition, the capsules tin flaming hold out opened to let the contents to hold out sprinkled on nutrient to facilitate dosing for patients who may stimulate got difficulty swallowing.
"When determining therapies for my patients inwards the moderate to severe stages of Alzheimer's disease, I consider the therapy's effectiveness, security profile in addition to its stay of administration. The FDA's blessing of Namzaric offers a novel therapeutic alternative that provides patients a fixed-dose combination of ii treatments oftentimes prescribed together, inwards 1 capsule," said Gustavo Alva, MD, Neuropsychiatrist in addition to Medical Director at ATP Clinical Research inwards Costa Mesa, CA in addition to volunteer faculty fellow member at University of California, Irvine.Namzaric volition hold out available inwards ii dosage strengths, 28/10 mg (memantine extended release/donepezil) in addition to 14/10mg (memantine extended release/donepezil) for patients amongst severe renal impairment.
Memantine ER is the active element inwards the currently marketed NAMENDA XR®, which is indicated for the handling of moderate to severe dementia of the Alzheimer's type.
Donepezil is the active element inwards ARICEPT®, which is indicated for the handling of mild to severe dementia of the Alzheimer's type. Actavis in addition to Adamas collaborated on the evolution of the fixed-dose combination.
Actavis volition stimulate got exclusive USA commercialization rights, spell Adamas volition retain exclusive commercialization rights exterior of the U.S.
Actavis expects to launch Namzaric inwards the USA inwards the instant quarter of 2015.
About the Clinical Trials
The efficacy in addition to security of the coadministration of memantine HCl extended unloose in addition to acetylcholinesterase inhibitors (AChEIs), including donepezil HCl, was based on the results of a randomized, double-blind, placebo-controlled case of 677 outpatients on a stable dose of AChEIs.
The clinical written report was non conducted amongst Namazaric; however, bioequivalence of Namazaric amongst coadministered memantine HCl extended unloose in addition to donepezil HCl was demonstrated.
Approximately 68% of the patients randomized to have either memantine HCl extended unloose 28 mg or placebo were taking donepezil every bit the AchEI at Baseline in addition to throughout the study. The results of this study, demonstrated statistically pregnant improvement inwards knowledge in addition to global component for patients treated amongst NAMENDA XR 28 mg plus an AChEI compared to placebo plus an AChEI.
The most ordinarily observed adverse reactions seen amongst memantine hydrochloride extended-release inwards patients amongst moderate to severe Alzheimer's disease, defined every bit those occurring at a frequency of at to the lowest degree 5% inwards the memantine hydrochloride extended-release grouping in addition to at a higher frequency than placebo, were headache, diarrhea, in addition to dizziness.
About Adamas Pharmaceuticals
Adamas Pharmaceuticals, Inc. is a specialty pharmaceutical companionship driven to amend the lives of those affected past times chronic disorders of the primal nervous system. The companionship achieves this past times modifying the pharmacokinetic profiles of approved drugs to practise novel therapeutics for role lone or inwards fixed-dose combination products.
For to a greater extent than information, catch Adamas at http://adamaspharma.com/
About Actavis
Actavis plc (ACT), headquartered inwards Dublin, Ireland, is a unique specialty pharmaceutical companionship focused on developing, manufacturing in addition to commercializing high character affordable generic in addition to innovative branded pharmaceutical products for patients about the world.
For to a greater extent than information, catch Actavis at www.actavis.com.
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