The Food and Drug Administration has formally rejected Merck & Co.s application for approval of Arcoxia as a prescription pain reliever. The company said it was informed of the agencys decision by letter.
Arcoxia was touted as the successor to Vioxx, which was pulled from the market in September 2004 after tests linked it to increased risk of heart attack and stroke. Like Vioxx, Arcoxia is also a so-called COX-2 inhibitor, designed to treat arthritis.
Arcoxia been under review by the FDA as an investigational selective COX-2 inhibitor since the application was submitted in December 2003 for a 60 mg once-daily dose along with review of a separate related application for a 30 mg once-daily dose submitted in April 2004.
In the non-approval letter, the FDA 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, said Peter S. Kim, Ph.D., president, Merck Research Laboratories. We pursued FDA approval of ARCOXIA because we believe strongly that new medicines are needed for patients whose osteoarthritis pain is inadequately managed with currently available therapies,". he said.
In addition, 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.
Panel's Advice
In rejecting Mercks application for Arcoxia, the FDA followed the lead of its advisory committee, which returned a negative report on the drug earlier this month.
In making its recommendation, the FDA panel said it could see no value in making Arcoxia available to arthritis sufferers. In fact, panelists said it likely posed the same cardiovascular risks as Vioxx and other Cox-2 drugs that have been pulled from the market.
The drug maker has promoted Arcoxia as safe as other pain relievers on the market and argued that it would be a valuable alternative for arthritis patients who have few other options.
Arcoxia is currently available in 63 countries in Europe, Latin America, the Asia-Pacific region and Middle East/Northern Africa. Merck said it will continue to market Arcoxia outside the U.S.
