US-based Forest Laboratories has submitted a new drug application (NDA) to the US Food and Drug Administration (FDA) for a fixed-dose combination (FDC) of memantine HCl extended release (ER) and donepezil HCl to treat moderate to severe Alzheimer’s type dementia.
The memantine ER-donepezil HCl fixed-dose combination is a once-daily oral capsule for patients currently taking memantine (10mg twice-daily or 28mg extended-release once-daily) and donepezil 10mg.
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In addition, the capsules can be opened to allow the contents to be sprinkled on apple sauce to facilitate dosing for patients who may have difficulty swallowing.
Forest and Adamas Pharmaceuticals have partnered on the development of the FDC, which Forest will have exclusive US commercialisation rights, while Adamas will retain exclusive commercialisation rights outside of the US.
The fixed-dose combination product is covered by multiple Adamas patents and a Forest patent that extend to 2029.
Banner Alzheimer’s Institute geriatric psychiatrist director Pierre Tariot said the concurrent use of memantine and donepezil is a well-established treatment option for patients with moderate to severe dementia related to Alzheimer’s disease.
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By GlobalData"Using the two drugs together appears to provide benefit over using acetylcholinesterase inhibitors alone," Tariot added.
"Reducing the number of pills by offering patients a fixed-dose combination helps lessen the daily medication burden and could improve patient adherence and compliance."
The NDA consisted of two dosage strengths, 28mg/10mg (memantine extended release/donepezil) and 14mg/10mg (memantine extended release/donepezil) for patients with severe renal impairment.
Memantine ER 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, which is also used to treat mild to severe dementia of the Alzheimer’s type.
Image: Histopathologic image of senile plaques seen in the cerebral cortex of a person with Alzheimer’s disease of presenile onset. Photo: courtesy of KGH.
