A single molecule of Namenda (memantine hydrochloride)

NEW YORK - Forest Laboratories and Merz Pharmaceuticals just announced that the FDA approved extended-release NAMENDA XR(TM) (generic name: memantine hydrochloride - eXtended Release).

The U.S. Food and Drug Administration approved NAMENDA XR for the treatment of moderate to severe dementia of the Alzheimer's type. NAMENDA XR is a 28 mg. once-daily extended-release formulation of NAMENDA.

The safety and efficacy of NAMENDA XR were established in a randomized, double-blind, placebo-controlled trial of 677 outpatients. The outpatients were already taking a cholinesterase inhibitor such as Aricept (generic name: donepezil). The results indicate that patients treated with NAMENDA XR experienced substantial benefits in cognition as compared to placebo.

NAMENDA XR will be covered by a U.S. Patent which expires in April 2015.

FDA approval is always the biggest hurdle for any new medication. With that milestone behind them, the companies are now working on the technical details of bringing NAMENDA XR to the market.

How Does Namenda Work?

Namenda® (memantine HCl) works in an entirely different way than other Alzheimer's disease medications. In a class by itself, Namenda targets a brain chemical known as glutamate.

Nerve cells rely on a variety of chemical messengers to transmit messages from one cell to the next. One of those chemical messengers is glutamate. Glutamate is a chemical in the brain that has been associated with learning and memory. Abnormal glutamatergic activity in the brain may lead to Alzheimer's disease symptoms. Namenda may help to improve abnormal glutamatergic activity.

While Namenda can be taken on its own, your doctor may have prescribed Namenda in combination with a different class of Alzheimer's medications, known as AChEIs (acetylcholinesterase inhibitors). This is because AChEIs, which include Aricept® (donepezil), Razadyne® (galantamine) and Exelon® (rivastigmine), work by targeting a different chemical in the brain called acetylcholine. There may be too little acetylcholine in the brain of a person with Alzheimer's disease. AChEIs work by addressing that problem.

When taken in combination, Namenda plus Aricept may work together to do more to help treat the symptoms of Alzheimer's disease.

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More Information:

About Namenda XR

NAMENDA XR (memantine HCl) extended release capsules are a 28mg once-daily formulation of NAMENDA approved for the treatment of moderate to severe dementia of the Alzheimer's type. NAMENDA, a twice daily immediate release formulation, was approved in October 2003. NAMENDA XR has a mechanism of action that focuses on the glutamate pathway, a target for the treatment of Alzheimer's disease.

Important Safety Information

Contraindications

• Namenda XR is contraindicated in patients with known hypersensitivity to memantine hydrochloride or to any excipients used in the formulation.

Precautions

• Caregivers should be instructed in the recommended administration (once per day) and about dose escalation (minimum interval of one week between dose increases).
• Namenda XR has not been systematically evaluated in patients with a seizure disorder.
• Namenda XR should be used with caution under conditions that raise urine pH (including alterations by diet, drugs and the clinical state of the patient). Alkaline urine conditions may decrease the urinary elimination of memantine, resulting in increased plasma levels.
• A dosage reduction is recommended in patients with severe renal impairment.
• Namenda XR should be administered with caution to patients with severe hepatic impairment.

Adverse Reactions

• In clinical trials, the most common adverse events occurring in at least 5% of patients treated with Namenda XR and at a greater frequency than placebo-treated patients were headache (6% vs 5%), diarrhea (5% vs 4%), and dizziness (5% vs 1%).

About Merz

Merz Pharmaceuticals researches, develops, produces and distributes innovative pharmaceutical products in the areas of neurology and psychiatry as well as in aesthetic dermatology and metabolism. In the area of Alzheimer's research, Merz Pharmaceuticals has achieved a leading position with the first active ingredient worldwide for the treatment of moderate to severe Alzheimer's disease. The Company is headquartered in Frankfurt am Main, Germany. To learn more about Merz, visit www.merz.com.

About Forest Laboratories

Forest Laboratories (NYSE: FRX) is a U.S.-based pharmaceutical company with a long track record of building partnerships and developing and marketing products that make a positive difference in people's lives. In addition to its well-established franchises in therapeutic areas of the central nervous and cardiovascular systems, Forest's current pipeline includes product candidates in all stages of development and across a wide range of therapeutic areas. The Company is headquartered in New York, NY. To learn more about Forest Laboratories, visit www.FRX.com.

Source:

Forest Laboratories, Inc.

Namenda.com

Week of June 27 - July 4, 2010

Reviewed by
Dr. Boaz Ancselovic, MD, Geriatrician, Alzheimer's Weekly.
Edited by Peter Berger, Alzheimer's Weekly.
COPYRIGHT © 2010 Alzheimer's Weekly LLC.
All Rights Reserved.