NEW YORK, Nov 26, 2004 /PRNewswire-FirstCall via COMTEX/ -- Forest Laboratories, Inc.
(NYSE: FRX) today announced that Combunox(TM) (Oxycodone HCl and Ibuprofen)
Tablets (CII), the first and only fixed-dose combination of the opioid
oxycodone HCl (5 mg) and the nonsteroidal anti-inflammatory drug (NSAID)
ibuprofen (400 mg), was approved by the U.S. Food and Drug Administration
(FDA) for the short-term management of acute, moderate to severe pain. Forest
expects to make Combunox available in the U.S. early next year.
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"The approval of Combunox provides physicians with a unique new option for
managing the type of pain experienced by many patients each year following
surgery or injury," said Howard Solomon, Chairman and Chief Executive Officer
of Forest Laboratories.
Combunox was licensed to Forest by BTG. Under terms of the licensing
agreement, Forest is responsible for manufacturing, sales, and marketing
activities of the product in the U.S.; Forest also has marketing rights for
the product in Canada and the United Kingdom, and sub-licensing rights in all
other countries of the world.
About Combunox and Acute Pain
Combunox combines oxycodone, which is generally considered up to 1.5 times
more potent than hydrocodone and nearly ten times more potent than codeine as
a narcotic analgesic, with ibuprofen at its typical analgesic dose. The
clinical benefit of Combunox is attributed to the distinct actions of each
component.
The FDA approved Combunox based on a review of efficacy data from three
double-blind, placebo-controlled trials. In these trials, Combunox provided
significantly greater pain relief than oxycodone 5 mg alone, ibuprofen 400 mg
alone, or placebo. Pooled data from the complete safety database, which
included a multiple-dose study, found Combunox to be safe and well tolerated.
The most common side effects included nausea, vomiting, somnolence, dizziness,
and headache, which typically are present with all products containing
opioids. Combunox is a Schedule II controlled substance.
Acute pain is generally caused by injury or surgery, and is the most
common reason why patients seek medical attention (25 million Americans
annually). In addition to unnecessary suffering, inadequately controlled
acute pain causes complications that can increase the length of hospital
stays, re-hospitalization rates, and outpatient visits.
Interested parties can sign up to receive more information on Combunox,
its prescribing information, or its availability by logging on to
http://www.Combunox.com or by calling (800) 678-1605, ext. 7301.
About Forest Laboratories and Its Products
Forest Laboratories' growing line of products includes: Lexapro(R)
(escitalopram oxalate), an SSRI antidepressant indicated for the initial and
maintenance treatment of major depressive disorder and for generalized anxiety
disorder in adults; Namenda(R) (memantine HCl), an N-methyl-D-aspartate
(NMDA)-receptor antagonist indicated for the treatment of moderate to severe
Alzheimer's disease; Celexa(R) (citalopram HBr), an antidepressant;
Benicar(R)* (olmesartan medoxomil), an angiotensin receptor blocker indicated
for the treatment of hypertension; Benicar HCT(TM) (olmesartan medoxomil
hydrochlorothiazide), an angiotensin receptor blocker and diuretic combination
product indicated for the second-line treatment of hypertension; and
Campral(R) (acamprosate calcium), a glutamate receptor modulator, indicated
for the maintenance of abstinence from alcohol in patients with alcohol
dependence who are abstinent at treatment initiation in combination with
psychosocial support.
Except for the historical information contained herein, this release
contains "forward-looking statements" within the meaning of the Private
Securities Reform Act of 1995. These statements are subject to risks and
uncertainties that affect our business, including risk factors listed from
time to time in the Company's SEC reports, including the Company's Annual
Report on Form 10-K for the fiscal year ended March 31, 2004, and on form 10-Q
for the period ended June 30, 2004, and September 30, 2004. Actual results may
differ materially from those projected.
*Benicar is a registered trademark of Sankyo Pharma, Inc.
SOURCE Forest Laboratories, Inc.
Charles E. Triano, Vice President - Investor Relations of
Forest Laboratories, Inc., +1-212-224-6714, Charles.Triano@frx.com
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