NEWS - Combunox: oxycodone and ibuprofen combo approved in US

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Oxycodone and ibuprofen combo approved in US

Rheumawire

Nov 30, 2004

Zosia Chustecka

New York, NY - A fixed-dose combination of the opioid oxycodone and the

nonsteroidal anti-inflammatory drug (NSAID) ibuprofen, known as Combunox

(Forest Laboratories, New York, NY), has been approved by the US FDA for

use in the short-term treatment of acute moderate to severe pain. It

should be available early next year, says the manufacturer.

The product contains 5-mg oxycodone and 400-mg ibuprofen and is a

Schedule II controlled substance. There are already several products

available that combine NSAIDs with opioids. Forest notes that oxycodone

is generally considered 1.5 times more potent than hydrocodone and

nearly 10 times more potent than codeine as a narcotic analgesic. The

company envisages the product being used by patients after surgery or

injury and suggests that adequately controlled acute pain can decrease

the length of hospital stays, rehospitalization rates, and outpatient

visits.

The approval was based on a review of efficacy data from 3 double-blind,

placebo-controlled trials. In these studies, the combination product

provided significantly greater pain relief than placebo or than either

ingredient used alone. Pooled data from the complete safety database,

which included a multiple-dose study, found the product to be safe and

well tolerated, the company says. The most common side effects included

nausea, vomiting, somnolence, dizziness, and headache, which are

typically present with all products containing opioids.

I'll tell you where to go!

Mayo Clinic in Rochester

http://www.mayoclinic.org/rochester

s Hopkins Medicine

http://www.hopkinsmedicine.org