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

The FDA on Wednesday approved a New Drug Application for Adamas Pharmaceuticals Inc's (NASDAQ: ADMS) 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 statement.

Adamas Pharmaceuticals jointly created the drug with Forest Laboratories, a recent acquisition of Actavis. Actavis will have exclusive U.S. commercialization rights while Adamas Pharmaceuticals will retain exclusive commercialization rights outside of the United States.

Namzaric is expected to be launched in the United States during the second quarter of 2015.

Shares of Adamas Pharmaceuticals were trading higher by nearly 21 percent Wednesday morning.