Pfizer starting huge Celebrex study

BusinessWeek Online is reporting that Pfizer is searching for a definitive answer on celebrex by funding a “multiyear, $100 million study to finally find out if the painkiller is safe.”

“The study, being run independently by the clinic, will compare three drugs: Celebrex (the Cox-2 drug from Pfizer), ibuprofen (sold under the brand name Motrin), and naproxen, sold under brand names such as Alleve.”

The study should answer a big question: Were the cardiovascular problems seen with the withdrawn painkiller Vioxx unique to that drug or a common problem for all so-called Cox-2 inhibitors? Merck pulled Vioxx from the market in the fall of 2004 after a study confirmed it was linked to a higher risk of cardiovascular problems, including heart attacks.

Celebrex fell under similar suspicion in December, 2004, when one Pfizer’s studies showed a possible link to increased cardiovascular risk at higher doses. Those fears have hammered the drug’s sales. This year Celebrex is expected to bring in just $1.7 billion in revenue, according to SG Cowen analyst Stephen M. Scala, vs. $3.3 billion in 2004.

The study should provide a wealth of information to individuals wrestling with how to treat their arthritis. The trial will focus on people with heart disease or at high risk for it. All patients will be given low-dose aspirin, which is a typical treatment for people with heart problems, as well as the drug Prilosec, to reduce stomach acid.

It’s “a risky study for Pfizer. It could find that Celebrex does pose a cardiovascular risk, and that would doom the product.”