Forest Laboratories submits new drug application for memantine extended release and donepezil fixed-dose combination for Alzheimer’s disease


Forest Laboratories and Adamas Pharmaceuticals announced Forest’s submission of a new drug application to the US Food and Drug Administration for a fixed-dose combination of memantine HCl extended release 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,” says Pierre Tariot, at the Banner Alzheimer’s Institute, who has also consulted for both Adamas and Forest.

The memantine extended release-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. 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 commercialisation rights while Adamas will retain exclusive commercialisation rights outside of the USA.