FDA Approves Namzaric Combo Drug for Alzheimer’s

The FDA has approved Namzaric, a fixed-dose combination drug for the treatment of moderate to severe Alzheimer’s dementia that combines memantine hydrochloride extended-release (Namenda XR, Activis) and donepezil hydrochloride (Aricept, Pfizer).

The complementary drugs are often co-prescribed, and data shows that combination therapy of Namenda XR, an NMDA receptor antagonist, and an acetylcholinesterase inhibitor (AChEI) like Aricept is more effective at improving cognition and function than an AChEI alone.

The drug will be launched in the United States by Activis in 2015 and will be available in two doses: 28/10 mg (memantine/donepezil) and 12/10 mg for patients with severe renal impairment.

The combination drug is designed for patients currently stabilized on doses of both memantine and donepezil. The new drug’s capsule can also be opened in order to sprinkle the contents on food for patients who have difficulty swallowing. 

Reference

1. Actavis News Release. Available here: http://www.actavis.com/news/news/thomson-reuters/actavis-and-adamas-announce-fda-approval-of-namzar