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FDA Wants More Safety Data on Merck Drug

Posted on: Saturday, 30 October 2004, 00:00 CDT

NEW YORK - The Food and Drug Administration told Merck & Co. that it requires further safety and efficacy data before it will approve its successor drug to now defunct pain reliever Vioxx, the pharmaceutical maker announced Friday.

Most analysts and doctors were expecting the FDA to seek additional information before approving Arcoxia 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.

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

Arcoxia is already sold in 48 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.

Merck spokeswoman Anita Larsen wouldn't comment beyond the company's statement so it was unclear what would be required to achieve final approval.

In midday trading on the New York Stock Exchange, Merck shares were up 1 cent at $31.58. The stock had been trading above $45 before the Vioxx recall on Sept. 30.

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.

Dr. Eric Matteson said he thought the FDA's decision was wise because physicians would not have felt comfortable prescribing Arcoxia without additional information on its cardiovascular safety. He maintained the study Merck released last week was not specifically designed to look at risk for heart attacks or strokes so it wasn't enough to give doctors confidence of Arcoxia's safety.

"I don't feel that there is sufficient safety data so far that makes us confident about this drug," said Matteson, a professor of medicine and consultant to the rheumatology department at the Mayo Clinic in Rochester, Minn.

Matteson said that even if the drug is deemed safe by the FDA there will be lingering concerns about it because of Vioxx.

"There will be a Vioxx hangover," Matteson said. Still, he said the 23,500 patient study should be enough to coax doctors to use it because there is a need for more cox-2 inhibitors, which are used because they reduce gastrointestinal problems such as bleeding linked to other pain relievers.

The company is also conducting another study to test Arcoxia's gastrointestinal safety profile that will also be completed in 2006.

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.

Merck desperately needs a new hit drug to replenish its sagging earnings. Vioxx was its second-best selling drug, accounting for 11 percent of the company's revenues last year.

The Vioxx withdrawal caused Merck's third quarter profit to fall 29 percent. Meanwhile, Merck's top seller, cholesterol medication Zocor, loses patent protection in 2006, and analysts are not overly enthusiastic about the company's pipeline.

Hundreds of lawsuits have been filed over the Vioxx withdrawal and one analyst believes Merck could wind up paying up to $12 billion to settle them.

(SUBS 7th-8th grafs, Merck spokeswoman ... to correct spelling of Larsen, UPDATE stock price. INSERTS four new grafs after 10th graf pvs, Merck is ... to ADDS doctor comment.)

Source: Associated Press/AP Online

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