Actavis, Adamas approved for Namzaric

DUBLIN and EMERYVILLE, Calif. — Actavis and Adamas Pharmaceuticals last week announced that the Food and Drug Administration approved Namzaric. According to the companies, the drug is used to treat moderate to severe dementia of the Alzheimer's type in patients stablized on memantine hydrochloride and donepezil hydrochloride.

 

"Namzaric combines, in one capsule, two complementary therapeutic agents which are often co-prescribed as approximately 70% of Namenda XR patients are also on AChEI therapy.  Both Namenda XR and donepezil have proven efficacy and safety, for the treatment of moderate to severe Alzheimer's disease. Additionally, data has shown that combination therapy with Namenda XR and an AChEI demonstrated greater improvement in cognition and global function verses an AChEI alone," said David Nicholson, Actavis SVP, global brands research and development. "Along with our partner Adamas, we are proud that this important therapy will provide a convenient and innovative treatment option for Alzheimer's patients and caregivers that reduces the number of capsules they are required to take each day for the treatment of this devastating disease."

 

Namzaric was formerly known as MDX-8704. It's a once-daily oral capsule indicated for patients currently taking memantine (10 mg twice daily or 28 mg extended-release once-daily) and donepezil in 10-mg dosage strength. The capsules can be open to allow the contents to be sprinkled on food for patients who have trouble swallowing. Namzaric will be available in two dosage strengths: 28/10 mg (memantine extended release/donepezil) and 14/10mg (memantine extended release/donepezil.)

 

"We are excited about the approval of Namzaric — the first fixed-dose combination of extended-release memantine and donepezil — and look forward to its launch by Actavis in 2015," said Gregory Went, Ph.D., chairman and CEO of Adamas Pharmaceuticals. "Namzaric is also the first FDA-approved FDC product to emerge from Adamas' platform for modifying the pharmacokinetic profiles of approved drugs, and we look forward to developing additional new treatments for individuals with serious neurological CNS disorders."