Federal regulators want more data before approving new Merck pain reliever to replace Vioxx

Friday, October 29th 2004, 11:15 am
By: News On 6

NEW YORK (AP) _ The Food and Drug Administration told Merck & Co. that it requires further safety and effectiveness data before it will approve its successor drug to now-defunct pain reliever Vioxx, the company said Friday.

Most analysts and doctors had not expected the FDA to give Arcoxia a green light now 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 known as cox-2 inhibitors.

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

Merck shares rose 43 cents or 1.36 percent to $32 a share in morning trading on the New York Stock Exchange.

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

Last week, Merck released positive study results for Arcoxia that found there was no statistical difference in cardiovascular problems 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.

Merck is scheduled to finish a 23,500-patient study that was focused on cardiovascular safety in early 2006.

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.