Forest Announces U.S. Availability of New Once-Daily NAMENDA XR
-- Treatment for moderate to severe Alzheimer’s Disease is now available to
patients in a convenient extended release formulation --
NEW YORK -- June 13, 2013
Forest Laboratories, Inc. announced today that NAMENDA XR^(TM) (memantine
hydrochloride) once-daily formulation is now available in pharmacies
throughout the United States. NAMENDA XR is approved by the U.S. Food and Drug
Administration (FDA) for the treatment of moderate to severe dementia of the
New NAMENDA XR 28 mg is a higher dose, once-daily extended-release formulation
of NAMENDA (memantine) immediate-release. The efficacy and safety of NAMENDA
XR was established in a randomized, double-blind, placebo-controlled trial of
677 outpatients on a stable dose of acetylcholinesterase inhibitors (AChEl).
AChEIs are a different class of prescription drugs often used in combination
with NAMENDA for the treatment of moderate to severe Alzheimer’s disease. The
results of this study, demonstrated 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. Cognition was measured by the
Severe Impairment Battery (2.6 unit mean difference). Global function was
measured by the Clinician’s Interview-Based Impression of Change (0.3. unit
mean difference). NAMENDA XR was studied in combination with commonly
prescribed AChEIs (donepezil, galantamine, or rivastigmine). Namenda XR can be
used alone or added to other acetylcholinesterase inhibitors 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%
“We are pleased to be introducing NAMENDA XR so that patients can benefit from
the convenience of a once-daily regimen that aligns with once-daily AChEIs,”
said Dr. Marco Taglietti, President Forest Research Institute. “The NAMENDA XR
study supports the existing body of evidence that memantine provides cognitive
and global benefits in patients with moderate to severe Alzheimer’s disease
either alone or with an AChEI.”
“Caring for a loved one with moderate to severe Alzheimer’s is a daily
challenge, especially when a caregiver is responsible for administering as
many as nine prescription medications every day,” said John Schall, President
and CEO of the Caregiver Action Network (CAN). “Treatment options that could
help lessen this burden may be a welcome relief for the millions of caregivers
across the U.S. who are already managing with multiple tasks on a daily
About Namenda XR
NAMENDA XR (memantine HCl) is a higher dose, once-daily formulation of Namenda
immediate release that was studied with commonly prescribed
acetylcholinesterase inhibitors. Its unique mechanism of action focuses on the
glutamate pathway, a target for the treatment of Alzheimer's disease.
Indicated for the treatment of moderate to severe dementia of the Alzheimer’s
type, the FDA approved NAMENDA XR based on demonstrated statistically
significant improvements in cognition and global function for patients treated
with NAMENDA XR 28 mg plus an AChEI compared to placebo plus an AChEI.
There is no evidence that NAMENDA XR or an AChEI prevents or slows the
underlying disease process in patients with Alzheimer’s disease.
Visit NamendaXR.com for more information about this new once-daily treatment
NAMENDA XR^TM (memantine hydrochloride) extended-release capsules are
indicated for the treatment of moderate to severe dementia of the Alzheimer’s
Important Safety Information
• 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
• NAMENDA XR has not been systematically evaluated in patients with a seizure
• 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.
About Forest Laboratories, Inc.
Forest Laboratories' (NYSE: FRX) longstanding global partnerships and track
record developing and marketing pharmaceutical products in the United States
have yielded its well-established central nervous system and cardiovascular
franchises and innovations in anti-infective, respiratory, gastrointestinal
and pain management medicine. Forest’s pipeline, the most robust in its
history, includes product candidates in all stages of development across a
wide range of therapeutic areas. The Company is headquartered in New York, NY.
To learn more, visit www.FRX.com.
Except for the historical information contained herein, this release contains
forward-looking statements within the meaning of the Private Securities
Litigation Reform Act of 1995. These statements involve a number of risks and
uncertainties, including the difficulty of predicting FDA approvals, the
acceptance and demand for new pharmaceutical products, the impact of
competitive products and pricing, the timely development and launch of new
products, and the risk factors listed from time to time in Forest
Laboratories' Annual Report on Form 10-K, Quarterly Reports on Form 10-Q, and
any subsequent SEC filings. Forest assumes no obligation to update
forward-looking statements contained in this release to reflect new
information or future events or developments.
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Forest Laboratories, Inc
Frank Murdolo, 212-224-6714
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