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Forest Labs and Adamas Pharmaceuticals Submit NDA for Alzheimer’s Disease Treatment

Tue, 03/04/2014 - 9:34am

Forest Laboratories and Adamas Pharmaceuticals have jointly announced Forest’s submission of a New Drug Application (NDA) to the Food and Drug Administration for a fixed-dose combination (FDC) of memantine HCl extended release (ER) and donepezil HCl for the treatment of moderate to severe dementia of the Alzheimer’s type.

“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. Using the two drugs together appears to provide benefit over using acetylcholinesterase inhibitors alone. 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,” said Pierre Tariot, MD, at the Banner Alzheimer’s Institute, who has also consulted to both Adamas and Forest.

The memantine ER-donepezil HCl FDC 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 applesauce to facilitate dosing for patients who may have difficulty swallowing.

The New Drug Application 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 indicated for the treatment of mild to severe dementia of the Alzheimer’s type. Forest and Adamas collaborated on the development of the fixed dose combination and Forest will have exclusive US commercialization rights while Adamas will retain exclusive commercialization rights outside of the US. The FDC product is covered by multiple Adamas patents and a Forest patent that extend to 2029.

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