New COMBUNOX(TM) (Oxycodone HCl and Ibuprofen) Tablets (CII) Now Available for the Short-Term Treatment of Acute, Moderate to Se
March 21 2005 - 8:05AM
PR Newswire (US)
New COMBUNOX(TM) (Oxycodone HCl and Ibuprofen) Tablets (CII) Now
Available for the Short-Term Treatment of Acute, Moderate to Severe
Pain NEW YORK, March 21 /PRNewswire-FirstCall/ -- Forest
Laboratories, Inc. (NYSE:FRX) announced today that COMBUNOX(TM)
(Oxycodone HCl and Ibuprofen) Tablets (CII) are now available to
physicians and pharmacies nationwide. COMBUNOX was approved by the
U.S. Food and Drug Administration (FDA) on November 26, 2004, for
the short-term (no more than seven days) management of acute,
moderate to severe pain. COMBUNOX is the first and only product to
combine 5 mg of oxycodone HCl and 400 mg of ibuprofen, which is the
highest dose of ibuprofen available in a combination opioid
product. (Logo:
http://www.newscom.com/cgi-bin/prnh/20001011/FORESTLOGO ) "We
believe that COMBUNOX provides physicians with a unique combination
tablet to treat people who suffer from short-term pain," said
Howard Solomon, Chairman and Chief Executive Officer of Forest
Laboratories. "It is an effective and well-tolerated medication for
the millions of Americans who need acute pain control following
injury or surgery." COMBUNOX and Pain Relief The FDA approval of
COMBUNOX is based on a review of efficacy data from three studies
in two different post-operative pain models (dental and
abdominal/pelvic pain). Data demonstrate that COMBUNOX provides
statistically superior pain relief compared to either of its
individual components alone or placebo.(1) "COMBUNOX is the first
pain medication to combine the strength of oxycodone and ibuprofen,
providing analgesia as well as anti-inflammatory properties. The
combination of these two proven agents in one tablet provides
physicians a powerful new option for addressing patients' pain
relief needs," said Charles Argoff, M.D., Neurologist, North Shore
University Hospital. "Untreated pain can be very debilitating to a
person, but providing proper pain relief allows patients to quickly
return to activities of basic daily living." The safety and
tolerability of COMBUNOX was established in single and multiple
dose studies. The most common side effects in all trials included
nausea, vomiting, somnolence, dizziness, and headache, which
typically are present with all products containing opioids.(2)
COMBUNOX is a Schedule II controlled substance. The recommended
dose of COMBUNOX is one 5mg/400mg tablet taken orally. Dosing
should not exceed four tablets in a 24-hour period and should not
exceed seven days. 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. Interested parties can get more
information on COMBUNOX and obtain the prescribing information by
visiting http://www.combunox.com/ or by calling 800-678-1605. About
Acute Pain About 25 million Americans experience pain each year as
a result of injury or surgery.(3) Left untreated, pain has a
significant negative impact on the sufferer's qualify of life,
affecting ability to concentrate, do their job, exercise,
socialize, get a good night's sleep and perform household
chores.(3) Acute pain is the most common reason why patients seek
medical attention in the United States.(3) 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 for adults; Benicar(R)* (olmesartan medoxomil), an
angiotensin receptor blocker indicated for the treatment of
hypertension; Benicar* HCT(R) (olmesartan medoxomil
hydrochlorothiazide), an angiotensin receptor blocker and diuretic
combination product indicated for the second-line treatment of
hypertension; 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;
and Combunox(TM) (Oxycodone HCl and Ibuprofen), an opioid and NSAID
combination indicated for the short-term management of acute,
moderate to severe pain. 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 periods ended June 30, September 30,
and December 31, 2004. * Benicar is a registered trademark of
Sankyo Pharma, Inc., and Campral is a registered trademark under
license from Merck Sante s.a.s., subsidiary of Merck KGaA,
Darmstadt, Germany. (1) Newman K. OXY-MD-05 A Double-Blind,
Placebo-Controlled, Single-Dose Parallel Study of the Analgesic
Efficacy and Safety of Oxycodone HCl/Ibuprofen 5/400 mg Compared to
Ibuprofen 400 mg Alone and Oxycodone HCl 5 mg in Patients with
Moderate to Severe Pain Following Dental Surgery. Forest Research
Institute, Jersey City. Report Date: November 12, 2001. p. 74. (2)
Combunox(TM) (Oxycodone HCI and Ibuprofen) Tablets Prescribing
Information. Forest Pharmaceuticals, St. Louis MO. (3) Berry, P:
(ed). Pain: Current Understanding of Assessment, Management, and
Treatments. Reston, VA: National Pharmaceutical Council, Inc.;
February 2004. pgs. 3, 13 and 15.
http://www.newscom.com/cgi-bin/prnh/20001011/FORESTLOGODATASOURCE:
Forest Laboratories, Inc. CONTACT: Charles E. Triano, Vice
President - Investor Relations of Forest Laboratories, Inc.,
+1-212-224-6714, Web site: http://www.frx.com/
http://www.combunox.com/
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