FDA Approves Adamas Pharmaceuticals' Alzheimer's Drug, Shares Soar

The FDA approved on Wednesday a New Drug Application for

Namzaric for the treatment of moderate to severe dementia of the Alzheimer's type. Namzaric will be available in two dosage strengths, 28/10 mg and 14/10 mg for patients with severe renal impairment. "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 in a