FDA Nixes Vioxx-Like Pain Drug
Drug, Called Arcoxia, Will Continue to Be Sold Overseas, Says Drug's Maker
April 27, 2007 -- The drug company Merck today announced that the FDA has rejected Merck's application to market Arcoxia, a new osteoarthritis drug.
Arcoxia is similar to Vioxx, a drug removed from the U.S. market in 2004 because of an increased heart attack and stroke risk.
The decision follows the advice of an FDA advisory panel, which voted 20 to 1 earlier this month to reject Arcoxia.
Arcoxia is in the class of nonsteroidal anti-inflammatory drugs (NSAIDs) known as Cox-2 inhibitors, which includes Vioxx and Bextra -- both removed from U.S. pharmacies -- as well as Celebrex, which is still on the market. Cox-2 drugs have a lower risk for stomach ulcers and gastrointestinal bleeding than other NSAIDs such as aspirin and ibuprofen.
Arcoxia is sold in 63 countries. The drug represented Merck's first attempt to return to the once-lucrative Cox-2 pain drug market in the U.S.
The company had hoped to convince experts that the drug was a better pain drug than related drugs -- and also that it was safer.
In a news release issued today, Merck says the FDA's letter indicated that Merck "would need to provide additional data in support of the benefit-to-risk profile for the proposed doses of Arcoxia in order to gain approval."
"We are disappointed with today's decision," says Peter S. Kim, PhD, president of Merck Research Laboratories, in Merck's news release.
Kim says Merck strongly believes that "new medicines are needed for patients whose osteoarthritis pain is inadequately managed with currently available therapies."
Kim also states that "there is more long-term safety data from controlled clinical trials, in terms of patient-years on treatment, for Arcoxia than for any other NSAID, including traditional NSAIDs and Cox-2 selective inhibitors."
Merck says it will continue to market Arcoxia outside the U.S.