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FDA approves new drug application for Alzheimer’s drug, Namzaric
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The FDA approved the new drug application for Namzaric, a fixed-dose combination of memantine hydrochloride extended-release and donepezil hydrochloride, for the treatment of moderate-to-severe Alzheimer’s disease, according to an Actavis and Adamas Pharmaceuticals press release.
The once-daily formulation of Namzaric – previously known as MDX-8704 – was approved in patients taking 10-mg twice-daily or 28-mg extended-release once-daily memantine hydrochloride and 10-mg donepezil hydrochloride.
The new formulation will be available in two dosage strengths: 28/10 mg (memantine extended release/donepezil) and 14/10 mg (memantine extended release/donepezil) for patients with severe renal impairment.
The most common adverse events were headache, diarrhea and dizziness.
Actavis will have exclusive U.S. commercialization rights to the drug, and Adamas will retain exclusive commercialization rights outside of the U.S., according to the press release. Actavis will release Namzaric in the US in the second quarter of 2015.