Actavis, Adamas Receive FDA Approval for Alzheimer’s Drug

Actavis plc (NYSE:ACT) and Adamas Pharmaceuticals Inc. (NASDAQ:ADMS) announced that the US Food and Drug Administration (FDA) has approved a new drug application for Namzaric.

Namzaric is a drug that’s been approved for the treatment of moderate to severe dementia in Alzheimer’s patients who have been “stabilized on memantine hydrochloride and donepezil hydrochloride.”

As quoted in the press release:

Namzaric, formerly known as MDX-8704, is a once-daily oral capsule for patients currently taking memantine (10 mg twice daily or 28 mg extended-release once-daily) and donepezil 10 mg. In addition, the capsules can be opened to allow the contents to be sprinkled on food to facilitate dosing for patients who may have difficulty swallowing.

David Nicholson, Actavis’ senior vice president, global brands R&D, commented:

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.

Meanwhile, Gregory T. Went, chairman and CEO of Adamas, said:

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. 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 disorders.

Click here to read the full Actavis plc (NYSE:ACT) and Adamas Pharmaceuticals Inc. (NASDAQ:ADMS) press release.