Forest Laboratories Announces Intention to Continue Marketing Both NAMENDA® TABLETS & Once-Daily NAMENDA XR® Into the Fall ...
June 10 2014 - 4:01PM
Business Wire
-- Patient, Caregiver, Physician Acceptance of
Benefits of NAMENDA XR® Strong --
-- Initiatives to Ensure Robust and Reliable
Product Supply Progressing--
-- Final Conversion to NAMENDA XR® Anticipated
Later this Year --
Forest Laboratories, Inc. (NYSE:FRX), a leading, fully
integrated, specialty pharmaceutical company, today announced that
it intends to continue to market both its NAMENDA® (memantine HCl)
5 mg and 10 mg tablets and once-daily NAMENDA XR® (memantine HCl)
extended-release capsules into the fall of 2014. The Company noted
that patient and caregiver response to the NAMENDA XR® product has
been exceptionally positive, with caregivers and physicians clearly
recognizing the benefits of the single daily dosing regimen. Forest
stated that its decision to defer final conversion to the NAMENDA
XR® product later in the year will not affect the company’s ability
to meet its financial objectives for the product.
“The conversion to the single daily dose has exceeded our
expectations with current scripts trending at approximately 40% for
NAMENDA XR®,” said Brent Saunders, Forest’s CEO and President. “We
have always maintained that the successful conversion to Namenda
XR® is based on three things: Patient, caregiver and healthcare
providers responding favorably to the benefits of the once-daily
dosing of the NAMENDA XR® product; ensuring that we achieved
appropriate levels of managed care coverage and formulary planning;
and ensuring that we optimize the efficiency of our manufacturing
capabilities to ensure adequate supply to support the ultimate
conversion to the XR product. Conversion rates are demonstrating
patient and payer acceptance of the benefits of the single daily
dose, and we continue to make progress in improving manufacturing
yield and efficiency. The success of the NAMENDA XR® conversion to
date provides us with the option of adjusting the timing of the
final conversion, while still meeting our financial
commitments.”
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
Forest Laboratories (NYSE:FRX) is a leading, fully integrated,
specialty pharmaceutical company largely focused on the United
States market. Forest markets a portfolio of branded drug products
and develops new medicines to treat patients suffering from
diseases principally in five therapeutic areas: central nervous
system, cardiovascular, gastrointestinal, respiratory, and
anti-infective. Forest’s strategy of acquiring product rights for
development and commercialization through licensing, collaborative
partnerships and targeted mergers and acquisitions allows Forest to
take advantage of attractive late-stage development and commercial
opportunities, thereby managing the risks inherent in drug
development. In January 2014, Forest acquired Aptalis
Pharmaceuticals for $2.9 billion in cash in order to gain access to
its GI and Cystic Fibrosis products, including treatments for
Ulcerative Proctitis, Duodenal Ulcers, H. Pylori, Anal Fissures,
and Pancreatic Insufficiency. In February 2014, Forest and Actavis
plc announced an agreement where Forest would be acquired for about
$25 billion in cash and stock. The acquisition of Forest by Actavis
is contingent upon regulatory and shareholder approvals.
Forest 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.
Investors:Forest LaboratoriesFrank J. Murdolo,
1-212-224-6714Vice President, Investor
Relationsmedia.relations@frx.com
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