New Pain Drug Gets Conditional OK

The Food and Drug Administration told Merck & Co. that it would approve the company's successor drug to the now defunct pain reliever Vioxx if it provides further safety and efficacy data, the big pharmaceutical company announced Friday. Its shares rose.

Most analysts and doctors didn't expect the FDA to give Arcoxia a green light because Merck pulled Vioxx from the market last month after a study showed it doubled patients risk of heart attacks and strokes. The two products are in the same class of drugs.

"I think it is a positive that the drug wasn't killed," Bert Hazlett, an analyst at SunTrust Robinson Humphrey.

But Hazlett said it is likely that the FDA will require more tests and that Arcoxia won't hit the market for several years. He doesn't believe the drug will begin generating significant sales until 2008.

In early trading on the New York Stock Exchange, Merck shares were up 29 cents at $31.86. It had been trading above $45 before the Vioxx recall on Sept. 30.

Merck said the FDA gave it an 'approvable' letter with the condition that the company provide further safety and efficacy information for the drug. It was unclear what the company would need to do to achieve final approval.

Last week, Merck released positive study results for the Arcoxia which found that there was no statistical difference in adverse cardiovascular events between it and diclofenac, an older pain reliever. However, the average length of time a patient was in the trial was nine months and Vioxx's dangers didn't manifest themselves until 18 months into the trial.

Merck is scheduled to finish a 23,500 patient study that was designed to study cardiovascular safety in early 2006. Many analysts and doctors believed Arcoxia would only be approved after that study is completed and it demonstrates the drug doesn't increase the risk of heart attacks and strokes

A 7,111-patient trial was presented last week at the American College of Rheumatology's annual meeting in San Antonio, and is part of the Merck's application for approval. It found that dropout rates due to stomach problems were more than double in the patients taking diclofenac than in those taking Arcoxia.

Arcoxia is already sold in 47 countries throughout the world.

"We continue to believe that Arcoxia has the potential to become a valuable treatment option for many Americans with arthritis and pain," chairman, president and chief executive Raymond V. Gilmartin said in a news release.

By Theresa Agovino