Forest Laboratories, Inc. has 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 US FDA for the short-term management of acute, moderate to severe pain. Forest expects to make Combunox available in the US early next year.
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 US; 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.
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, Forest Labs said in a release.
"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 CEO of Forest Laboratories.
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.