Actavis and Adamas Pharmaceuticals said today they won FDA approval for Namzaric, in a rare favorable outcome for treatments indicated for Alzheimer’s disease.

Namzaric is indicated for the treatment of moderate to severe dementia of the Alzheimer's type in patients stabilized on memantine hydrochloride and donepezil hydrochloride. Formerly known as MDX-8704, Namzaric 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. The capsules can be opened to allow the contents to be sprinkled on food to facilitate dosing for patients who may have difficulty swallowing.

Namzaric is a fixed-dose combination (FDC) of memantine hydrochloride extended-release, a NMDA receptor antagonist; and donepezil hydrochloride, an acetylcholinesterase inhibitor (AChEI).

The two are often co-prescribed, as 70% of Namenda XR patients are also on AChEI therapy—yet in clinical trials, combination therapy with Namenda XR and an AChEI demonstrated greater improvement in cognition and global function verses an AChEI alone, according to the companies.

“Along with our partner Adamas, we are proud that this important therapy will provide a convenient and innovative treatment option for Alzheimer's patients and caregivers that reduces the number of capsules they are required to take each day for the treatment of this devastating disease,” David Nicholson, Actavis svp, Global Brands R&D, said in a statement.

Gregory T. Went, Ph.D., Adamas’ chairman and CEO, added that Namzaric is the first FDA-approved FDC product to emerge from his company’s platform for modifying the pharmacokinetic profiles of approved drugs.

Memantine extended-release is the active ingredient in the currently marketed Namenda XR®, which like Namzaric is indicated for the treatment of moderate to severe dementia of the Alzheimer's type. Donepezil is the active ingredient in Aricept®, which is indicated for the treatment of mild to severe dementia of the Alzheimer's type.

Developers of Alzheimer’s treatments have long struggled to create successful new drugs. Only a handful of drug successes have ever reached the market, and even they merely slow progression of symptoms six to 12 months. In July, a Cleveland Clinic study found a 99.6% failure rate of clinical trials for Alzheimer's drug candidates between 2002 and 2012.

The FDA based its approval of Namzaric on results of a randomized, double-blind, placebo-controlled trial of 677 outpatients on a stable dose of AChEIs. The study showed statistically significant improvement in cognition and global function for patients treated with Namenda XR 28 mg plus an AChEI, compared to placebo plus an AChEI, Actavis and Adamas said.

While the clinical study was not conducted with Namazaric, the companies showed to the agency’s satisfaction the bioequivalence of Namazaric with co-administered memantine HCl extended-release and donepezil HCl. Approximately 68% of the patients randomized to receive either memantine HCl extended release 28 mg or placebo were taking donepezil as the AchEI at baseline and throughout the study.

The most commonly observed adverse reactions seen with memantine hydrochloride extended-release in patients with moderate to severe Alzheimer's disease, defined as those occurring at a frequency of at least 5% in the memantine hydrochloride extended-release group and at a higher frequency than placebo, were headache, diarrhea, and dizziness.

Actavis and Adamas collaborated on the development of the fixed-dose combination. Actavis will have exclusive U.S. commercialization rights, while Adamas will retain exclusive commercialization rights outside of the U.S.

Actavis expects to launch Namzaric in the U.S. in the second quarter of 2015, the companies said.








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