Forest Laboratories to Discontinue NAMENDA® Tablets, Focus on Once-Daily NAMENDA XR®
February 14 2014 - 4:15PM
Business Wire
Decision Supported by Positive Reception of
NAMENDA XR by Physicians, Patients, and Caregivers
Forest Laboratories, Inc. (NYSE:FRX), a leading, fully
integrated, specialty pharmaceutical company largely focused on the
United States market, today 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.
“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.
About NAMENDA XR®
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).
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.
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 www.NamendaXR.com 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
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.
For Forest Laboratories, Inc.Investors:Frank J.
Murdolo, 1-212-224-6714Vice President, Investor
Relationsmedia.relations@frx.comorMedia:Amanda KaufmanSenior
Manager, Corporate Communications and Media
Relationsamanda.kaufman@frx.comorSard Verbinnen & CoHugh Burns
/ Lesley Bogdanow / Pamela Blum1-212-687-8080
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