Celecoxib (Celebrex), a COX-2 specific non-steroidal anti-inflammatory drug, was launched on May 9 during the British Society of Rheumatology annual meeting. The drug will be co-promoted by Searle and Pfizer (see p738).
Celecoxib is the second of the new COX-2 specific agents to be marketed in the UK. It is licensed for use in both rhematoid arthritis and osteoarthritis, while the first drug, rofecoxib (Vioxx), is licensed only for osteoarthritis.
Speaking at the launch of celecoxib, Dr Frank McKenna (consultant rheumatologist, Trafford General hospital) said that there were problems in getting the COX-2 specific drugs included in hospital formularies because of their higher cost. However, in his view, the drugs would be useful for patients at particular risk of gastrointestinal complications with standard NSAIDs, including the elderly. "We don't know if there is still a residual risk of ulcer development or bleeding but, if there is, the risk is tiny," he said. The new drugs could be used as an alternative to giving an NSAID with a gastroprotective agent.
Dr McKenna suggested that the COX-2 selective agents would also be useful in patients taking steroids and in patients who needed an NSAID but had not been able to tolerate standard compounds.
As with rofecoxib, the Medicines Control Agency has classed celecoxib as a subclass of NSAIDs and the prescribing information carries standard NSAID warnings. Dr Peter Bowen-Davies (associate medical director, Pfizer) said that the company hoped that, as more data were collected and the safety profile was clarified, the coxibs might be redefined as a separate class.
Celecoxib is contraindicated in women of childbearing age, unless they are using effective contraception, because of reports of teratogenicity in animal studies. At the same time, the manufacturer warns against reliance on the pill, because of a possible interaction with celecoxib. Interaction studies are being carried out.
Searle says that, since the launch of celecoxib last year in the US, over 10 million patients have received the drug.
In the United States, celecoxib is also licensed for use in the treatment of familial adenomatous polyposis, an inherited condition that leads to premature bowel cancer. This use relates to the finding that COX-2 is involved in polyp formation. According to Dr Mark Layton (medical adviser, Pfizer), there is interest now in investigating the use of COX-2 specific inhibitors in the prevention of several other types of cancer.