Forest files at FDA combination memantine + donepezil for Alzheimers Disease

Forest Laboratories, Inc. and Adamas Pharmaceuticals Inc. have announced Forest�s submission of a New Drug Application (NDA) to the FDA 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 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 will have exclusive US commercialization rights while Adamas will retain exclusive commercialization rights outside of the US.