FDA Approves Combunox Tablets (CII) for Short-Term Treatment of Acute, Moderate to Severe Pain

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FDA Approves Combunox Tablets (CII) for Short-Term Treatment of Acute,

Moderate to Severe Pain

http://www.medicalnewstoday.com/medicalnews.php?newsid=16947

27 Nov 2004

Forest Laboratories, Inc (NYSE: FRX) today announced that Combunox

(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.

" 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 , 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.