Celebrex Consumer Information

Celebrex is no more effective than its competitors at fighting pain and inflammation--results for all of these drugs tend to vary among individuals. So the primary justification for switching to Celebrex--especially if we'll have to pay a premium--would be that it's a safer choice. But how much safer is it really?

The story behind the publicity is complex. Traditional NSAID's block an enzyme called cyclo-oxygenase or COX, which scientists once identified as a cause of arthritis inflammation and pain. Then, in 1991, researchers discovered that there were two types of this enzyme: COX-2, which triggers inflammation, and COX-1, which seems to protect the stomach lining. In theory, a drug that blocked COX-2 without affecting COX-1 could alleviate aches and pains without damaging the digestive tract.

Celebrex, Vioxx and similar drugs that are still in the pipeline are all designed to fit that profile. As a result, drug makers are attempting to market them as a new class of drugs called COX-2 inhibitors.

Celebrex may never match Pfizer Inc's impotence pill for headlines or notoriety, but it could ultimately prove just as big a revenue generator. In fact, if sales continue at the current pace, SG Cowen analyst Stephen M. Scala expects Celebrex sales to hit $550 million this year and $3 billion annually by 2002.

Still, there are plenty of hurdles to making those projections reality. Celebrex is the first of a new category of pain drugs, so-called Cox-2 inhibitors, to win approval. But Merck & Co. has its own Cox-2 product, Vioxx, which is expected to hit the market in four months. Meanwhile, although Searle's data showed great short-term safety benefits over current arthritis remedies--which can cause side effects such as stomach bleeding--it's unclear whether that edge will persist with long-term use. Also, health-maintenance organizations are resisting covering Celebrex until the long-term benefits are proven.

What gives the new drugs such great potential? Cox-2 inhibitors, which get their name from the enzyme they block, are expected to provide the same relief as non steroidal anti-inflammatory drugs (NSAID's) like ibuprofen or naproxen, but with far fewer intestinal side effects such as ulcers. But the Food & Drug Administration wasn't convinced by Searle's data showing Celebrex is safer than the NSAID's over the long term, and it is requiring that the drug's label carry a version of the standard NSAID warning on stomach side effects until more data are available.

Industry pros figure that decision contributed to Searle's pricing. Celebrex will cost about $2.42 per day, less than analysts had expected. That also reflects pressure from managed-care operators that are trying to get control of soaring prescription drug costs. Searle and Pfizer consulted with HMO's, doctors, and patient groups, testing 700 different pricing models before settling on the current figure. Even so, HMO's including Aetna U.S. Healthcare, United Healthcare Corp. and Wellpoint Health Networks Inc. are trying to limit use of the drug for now through higher co-payments--$25 a month at United Healthcare--or by restricting it to people at risk for intestinal problems.

LOW RISK. Celebrex' price is competitive with some popular NSAID's, but it is more costly than generic arthritis drugs that cost as little as 10 cents a day. And there is the risk that unexpected side effects could surface. Researchers at the University of Pennsylvania released a study in January raising questions about whether the Cox-2 drugs could cause blood clotting. A Searle spokesperson says Celebrex was tested in 10,000 patients, and no increased risk of cardiovascular events was seen.