Forest Labs. Submits NDA For FDC Of Memantine HCl ER And Donepezil HCl

(RTTNews) - Forest Laboratories Inc. (FRX) and Adamas Pharmaceuticals Inc., a privately held specialty pharmaceutical company, announced Forest's submission of a New Drug Application or NDA to the Food and Drug Administration for a fixed-dose combination or FDC of memantine HCl extended release or 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 company said that 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.

Alzheimer's disease is a progressive, neurodegenerative disorder characterized by problems with memory, thinking and behavior that eventually become severe enough to affect daily tasks.