FDA backs Actavis' Namzaric, but issues CRL on nebivolol/valsartan combo

The US Food and Drug Administration has approved the New Drug Application for Namzaric (formerly known as MDX-8704), a fixed-dose combination (FDC) of memantine extended-release, a NMDA receptor antagonist, and donepezil, an acetylcholinesterase inhibitor, from Ireland-headquartered generics major Actavis (NYSE: ACT) and partner Adamas Pharmaceuticals (Nasdaq: ADMS).

Namzaric was approved for the treatment of moderate to severe dementia of the Alzheimer's type in patients stabilized on memantine hydrochloride and donepezil hydrochloride. The drug is expected to be launched in the USA during the second quarter of 2015.

"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 senior vice president, Global Brands R&D. "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."