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Merck seeking FDA approval for Arcoxia

March 21, 2007

BY K. KERR; Newsday

New drug for arthritis?... Merck seeking FDA approval for Arcoxia, a chemical relative of Vioxx, which was linked to heart attacks.

In a bid to recapture a piece of the arthritis pain-relief market, Merck & Co. is seeking government approval for Arcoxia, a chemical relative of Vioxx, the drug pulled off drugstore shelves in 2004 after being linked to heart attacks.

In its last full year on the market, Vioxx brought in about $2.5billion in sales. If the Food and Drug Administration approves Arcoxia, Merck could recoup some of those sales.

On April 12 an FDA advisory panel will consider approval of Arcoxia for osteoarthritis; it is already sold in 62 other countries. The FDA usually follows advisory panel recommendations.

Arcoxia, like Vioxx, belongs to a group of drugs called COX-2 inhibitors, which block an enzyme that causes arthritis pain. Celebrex is the only COX-2 drug still on the market.

A Merck study of 34,000 patients compared Arcoxia to diclofenac, a nonsteroidal, anti-inflammatory drug sold mostly outside the United States under the brands Cataflam and Voltaren.

Merck says Arcoxia users had somewhat fewer heart attacks than diclofenac users but were more likely to develop hypertension. Arcoxia also led to fewer upper gastrointestinal problems, Merck says.

Christopher Loder, a Merck spokesman, said, "We believe Arcoxia has the potential to become a valuable treatment option for many Americans suffering from osteoarthritis."

Dr. Andrew Porges, a rheumatologist at St. Francis Hospital in Roslyn, participated in a Merck clinical trial for Arcoxia several years ago.

He said Merck must prove Arcoxia's cardiovascular risks are no greater than those posed by other anti-inflammatory drugs. "If the drug showed no significant increase in hypertension or edema relative to standard anti-inflammatories, I would think the drug [Arcoxia] would be safe," Porges said.

Still, Porges said he'd prescribe Arcoxia only for patients whose medical history - such as bleeding problems - precludes other pain drugs.

Dr. Prem Chatpar, chief of rheumatology at Plainview Hospital, also tested Arcoxia for Merck and said most of his patients "did remarkably well. However, "COX-2 inhibitors in general have to be used with caution now," he said, noting the need for blood pressure screening. "I think the same will hold true for Arcoxia."

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