Actavis Gains FDA Approval for Combination Drug

Actavis plc and Adamas Pharmaceuticals Inc., a specialty pharmaceutical company, have received approval from the US Food and Drug Administration (FDA) for their new drug application for Namzaric, a fixed-dose combination (FDC) of memantine hydrochloride extended-release, a NMDA receptor antagonist, and donepezil hydrochloride, an acetylcholinesterase inhibitor. Namzaric was approved for the treatment of moderate to severe dementia of the Alzheimer’s type in patients stabilized on memantine hydrochloride and donepezil hydrochloride.

Actavis and Adamas collaborated on the development of the fixed-dose combination. Actavis will have exclusive US commercialization rights while Adamas will retain exclusive commercialization rights outside of the US. Actavis expects to launch Namzaric in the US in the second quarter of 2015.

Adamas is currently developing its lead wholly owned product candidate, ADS-5102, for a complication of Parkinson’s disease known as levodopa-induced dyskinesia, or LID, and is evaluating other potential indications. The company’s portfolio also includes two approved products developed with Forest Laboratories, which Actavis acquired in 2014. The first is a fixed-dose combination product, Namzaric, and the second is a controlled-release product, Namenda XR. Forest, now a subsidiary of Actavis, markets both products in the United States under an exclusive license from Adamas.

Source: Actavis

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