FDA approves Combunox tablets for the short-term treatment of acute, moderate to severe pain

Forest Laboratories have 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 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.

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.



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