Forest Announces U.S. Availability of New Once-Daily NAMENDA XR
June 13 2013 - 8:00AM
Business Wire
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 Alzheimer’s type.
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% vs 1%).
“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 basis.”
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 regimen.
NAMENDA XRTM (memantine hydrochloride) extended-release capsules
are indicated for the treatment of moderate to severe dementia of
the Alzheimer’s type.
Important Safety Information
Contraindications
• 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.
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.
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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