Sunday, February 16

Namenda's Switch to Namenda XR

If you use Namenda (also called memantine or Ebixa) for Alzheimer's, there is an important change planned for August 15. Learn about the move to Namenda XR.

NEW YORK - Forest Laboratories announced that it plans to discontinue the sale of NAMENDA® (memantine HCl) 5 mg and 10 mg tablets effective August 15, 2014. Forest has notified the U.S. Food and Drug Administration of this decision. The oral solution of NAMENDA and once-daily NAMENDA XR® (memantine HCl) extended-release capsules will continue to be available. Both NAMENDA and NAMENDA XR are indicated for the treatment of moderate to severe Alzheimer’s disease.
“Given the day-to-day challenges of caring for someone with Alzheimer’s disease, there is a need for treatments that simplify a patient’s daily regimen and may help caregivers manage their loved ones’ needs”

“NAMENDA XR offers important benefits, including convenient, once-daily dosing, which is particularly meaningful for this patient population and their caregivers. Our decision to focus on NAMENDA XR is supported by these benefits as well as the positive feedback we’ve received from physicians and caregivers since the launch of NAMENDA XR,” said Marco Taglietti, MD, Chief Medical officer and EVP, Drug Development and Research of Forest. “The conversion also allows us to streamline our resources and explore innovative new compounds that may be effective for the treatment of Alzheimer’s disease, including the fixed-dose combination of NAMENDA XR and donepezil, which is under development.”

Importantly, physicians can switch patients from NAMENDA to NAMENDA XR the very next day without titration, as outlined in the FDA-approved package insert. In addition to its convenient dosing, NAMENDA XR capsules can be opened and the contents sprinkled on applesauce for patients who have difficulty swallowing pills.

“Given the day-to-day challenges of caring for someone with Alzheimer’s disease, there is a need for treatments that simplify a patient’s daily regimen and may help caregivers manage their loved ones’ needs,” said Gustavo Alva, MD, Neuropsychiatrist and Medical Director at ATP Clinical Research in Costa Mesa, CA. “For many families, NAMENDA XR is already fulfilling this need as a once-a-day treatment alternative.”

Forest sponsored a third-party survey that included 250 physicians treating Alzheimer’s patients and 250 caregivers of Alzheimer’s patients. Physicians surveyed responded that NAMENDA XR once daily administration was important in their decision to prescribe the medication. Also, a majority of caregivers responded that they were satisfied with the once daily dosing of NAMENDA XR.

Dr. Taglietti further noted: “Forest has provided effective treatments and education to the Alzheimer’s community for the past decade, and we remain fully committed to delivering products that can improve the lives of patients and their loved ones.”

Forest is actively communicating with healthcare providers, pharmacists, patients, and caregivers to notify them of the discontinuation of NAMENDA and the continued availability of NAMENDA XR. Patients and caregivers with questions can call Forest’s dedicated toll-free number, 1-844-TREAT-AD.


NAMENDA XR (memantine HCl) extended release capsules are a higher dose, once-daily formulation of NAMENDA immediate release indicated for the treatment of moderate to severe dementia of the Alzheimer’s type. Its mechanism of action focuses on the glutamate pathway, a target for the treatment of Alzheimer's disease. The efficacy and safety of NAMENDA XR was established in a 24 week, randomized, double-blind, placebo-controlled trial of 677 outpatients on a stable dose of acetylcholinesterase inhibitors (AChEl).

NAMENDA XR 28 mg plus an AChEI demonstrated statistically significant improvement in cognition and global function compared to placebo plus an AChEI. Cognition was measured by the Severe Impairment Battery Scale (2.6 unit mean difference). Global function was measured by the Clinician’s Interview-Based Impression of Change Scale (0.3. unit mean difference).

There is no evidence that NAMENDA XR or an AChEI prevents or slows the underlying disease process in patients with Alzheimer’s disease.

Dosing and Administration
  • The recommended starting dose of NAMENDA XR is 7 mg once daily. The recommended target dose is 28 mg once daily. The dose should be increased in 7 mg increments to 28 mg once daily. The minimum recommended interval between dose increases is one week and only if the previous dose has been well tolerated. The maximum recommended dose is 28 mg once daily.
  • It is recommended that a patient who is on a regimen of 10 mg twice daily of NAMENDA tablets be switched to NAMENDA XR 28 mg once-daily capsules the day following the last dose of a 10 mg NAMENDA tablet. There is no study addressing the comparative efficacy of these 2 regimens.
  • It is recommended that a patient with severe renal impairment who is on a regimen of 5 mg twice daily of NAMENDA tablets be switched to NAMENDA XR 14 mg once-daily capsules the day following the last dose of a 5 mg NAMENDA tablet.

Special Populations
  • NAMENDA XR should be administered with caution to patients with severe hepatic impairment.
  • A target dose of 14 mg/day is recommended in patients with severe renal impairment (creatinine clearance of 5-29 mL/min, based on the Cockcroft-Gault equation).


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

Warnings and Precautions
  • 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 and a possible increase in adverse effects.
  • NAMENDA XR has not been systematically evaluated in patients with a seizure disorder.

Adverse Reactions
  • The most commonly observed adverse reactions seen in patients administered NAMENDA XR (28 mg/day) in a controlled clinical trial, defined as those occurring at a frequency of at least 5% in the NAMENDA XR group and at a higher frequency than placebo were headache (6% vs 5%), diarrhea (5% vs 4%), and dizziness (5% vs 1%).

Drug Interactions
  • No drug-drug interaction studies have been conducted with NAMENDA XR, specifically. The combined use of NAMENDA XR with other NMDA antagonists (amantadine, ketamine, or dextromethorphan) has not been systematically evaluated and such use should be approached with caution.

Please visit for more information and full prescribing information.

About Forest Laboratories and Its Products

Forest Laboratories (NYSE: FRX) is a leading, fully integrated, specialty pharmaceutical company largely focused on the United States market. The Company markets a portfolio of branded drug products and develops new medicines to treat patients suffering from diseases principally in the following therapeutic areas: central nervous system, cardiovascular, gastrointestinal, respiratory, anti-infective, and cystic fibrosis. Our strategy of acquiring product rights for development and commercialization through licensing, collaborative partnerships, and targeted mergers and acquisitions allows us to take advantage of attractive late-stage development and commercial opportunities, thereby managing the risks inherent in drug development. The Company is headquartered in New York, NY. To learn more, visit


  1. Hello, are you losing your patent protection on the existing dosage and delivery system, and it's just a coincident that you are shifting to this new larger dose and patent-able delivery system? Will someone else sell a generic of the existing product at a much lower price? Just asking.
    Richard Taylor

  2. Why does the FDA grant full patent protection on the same drug that has been modified to provide slow release compared to all that's involed and expense to develop a new drug? I can see granting a modest benefit but not a new patent.The same thing happened when Aricept was about to go off patent.My wife has been on these drugs for over 15 years. tom twichell

    Both the ''regular'' and XR versions of Namenda are UNAVAILABLE at most pharmacies since late July 2014 - and when they check with their supplier (McKesson) the pharmacies are told it is out of stock and is not yet available for reorder for the XR and the 5 & 10mg can no longer be ordered.
    URGENT URGENT URGENT - continued care is important for Alzheimer's patients. This medication can not be stopped then restarted!


Your comments (up to 200 words):

The Guide

Free Ebook:
15 Simple Things You Can Do to Know You Are Trying Your Best for Parents with Dementia or Memory Loss










Diet & Nutrition

  1. Foods
  2. Coconut Oil
  3. Dairy
  4. Diets
  5. Fruit & Vegetables
  6. Herbs & Spices
  7. Medical Food (FDA)
  8. Mediterranean
  9. Recipes
  10. Risky Foods
  11. Tips
  12. Vitamins &



All About