Forest Files NDA For Alzheimer's Combination Therapy
Forest Laboratories announced it has submitted an NDA to the FDA for the fixed dose combination of memantine HCL extended release and donepezil HCL as treatment for moderate to severe dementia related to Alzheimer’s disease. Forest Laboratories and Adamas Pharmaceuticals are in collaboration over the development of the fixed dose combination therapy.
Banner Alzheimer’s Institute’s Pierre Tariot, who has also consulted to both Adamas and Forest, 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. 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.”
Alzheimer’s disease is a neurodegenerative disorder associated with problems with memory, mental abilities, and behavior, which progressively become severe as to affect daily life of patients. Approximately 5.2 million people in the US alone are currently living with the disease. Alzheimer’s disease is the fifth leading cause of death in the US among patients ages 65 and older. In 2010, Alzheimer’s disease was reported as an underlying cause of death for over 83,000 patients in the US.
Memantine ER-donepezil HCl FDX is a once-daily oral capsule marketed as NAMENDA XR, while Donepezil is the active ingredient in ARICEPT. Both drugs are used for patients experiencing moderate to severe dementia of the Alzheimer’s type. The NDA is comprised of two dosage strengths 28mg/10mg (memantine extended release/donepezil) and 14mg/10mg (memantine extended release/donepezil) for patients diagnosed with severe renal impairment.
Adamas will retain exclusive commercialization rights outside the US, while Forest Laboratories will have exclusive commercialization rights in the US. The therapy is covered by multiple patents secured by Adamas and a Forest patent that extend to 2029.