Actavis and Adamas receive FDA approval for Namzaric to treat dementia

FDA has approved the new drug application (NDA) for Namzaric to treat moderate to severe dementia of the Alzheimer’s type in patients stabilised on memantine hydrochloride and donepezil hydrochloride.

Both the companies partnered on the development of the fixed-dose combination. While Actavis will own exclusive US commercialisation rights, Adamas will retain exclusive commercialisation rights outside of the US.

Actavis global brands senior vice president David Nicholson said: "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."

Previously known as MDX-8704, Namzaric is a once-daily oral capsule for patients currently taking memantine and donepezil 10mg.

Namzaric is said to be available in two dosage strengths, 28/10 mg (memantine extended release/donepezil) and 14/10mg (memantine extended release/donepezil) for patients with severe renal impairment.

The efficacy and safety of the coadministration of memantine HCl extended release and acetylcholinesterase inhibitors (AChEIs), including donepezil HCl, was based on the results of a randomized and double-blind, placebo-controlled study of 677 outpatients on a stable dose of AChEIs.

The clinical study was not carried out with Namazaric, while bioequivalence of Namazaric with coadministered memantine HCl extended release and donepezil HCl was demonstrated.

Adamas Pharmaceuticals chairman and CEO Gregory Went said: "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 CNS disorders."

Actavis plans to launch Namzaric in the US in the second quarter of 2015.

Image: Actavis Biologics Ltd, Estuary Banks, Liverpool. Photo: courtesy of Rept0n1x.