Merck urges U.S. panel to back Vioxx successor
Last Updated: 2007-04-12 14:00:45 -0400 (Reuters Health)
By Lisa Richwine
GAITHERSBURG, Md. (Reuters) - A pain reliever in the same family as the recalled drug Vioxx should be approved to provide an alternative for patients who do not respond well to current options, maker Merck & Co Inc. argued to a U.S. advisory panel on Thursday.
Merck is seeking clearance to sell the pill, Arcoxia, in the United States for treating osteoarthritis, which causes pain from wear and tear on joints. The drug is sold in 63 countries.
Studies showed Arcoxia was as safe for the heart as many older treatments, the company told U.S. Food and Drug Administration advisers. Merck pulled Vioxx from the market in 2004 after research found it raised heart attack and stroke risk.
More than a dozen prescription and over-the-counter painkillers remain available to treat arthritis, but not all patients tolerate them or receive adequate pain relief, Merck said.
Arcoxia, known generically as etoricoxib, offers an advantage because patients developed fewer ulcers compared with an older drug, diclofenac, in a large study of more than 34,000 patients, Merck said.
"Patients with osteoarthritis want and deserve additional treatment options. We believe data indicate etoricoxib would be a valuable treatment option for many of these patients," said Dr. Scott Korn, executive director for clinical research at Merck Research Laboratories.
FDA reviewers, however, noted that Arcoxia patients dropped out of Merck's largest study at a higher rate than diclofenac users because of high blood pressure.
They also questioned if Arcoxia was gentler on the stomach. Complicated gastrointestinal problems, such as intestinal perforations or obstructions, were about the same for Arcoxia and diclofenac, FDA reviewer Dr. Robert Shibuya said.
Dr. David Graham, an FDA scientist and outspoken critic of Vioxx and similar drugs, said he felt Arcoxia "probably confers substantial increase in cardiovascular risk." He said Merck's comparison to diclofenac was inappropriate because the older medicine is little used in the United States and viewed by some as among the most dangerous pain relievers for the heart.
Widespread use could lead to "a potential public health disaster" and a "repeat of what we have with (Vioxx)," he told the panel.
The advisers, experts from outside the FDA, are scheduled to decide later on Thursday whether to recommend approval for Arcoxia. The agency is not required to follow panel recommendations but usually does.
Both Vioxx and Arcoxia target the Cox-2 enzyme involved in inflammation, as does Pfizer Inc.'s approved drug Celebrex. They are part of a larger class of drugs known as non-steroidal anti-inflammatory drugs, or NSAIDs.
Nearly 21 million Americans have osteoarthritis, according to the Arthritis Foundation. Most are over age 45.
Arcoxia had 2006 global sales of $265 million.
Merck shares were up 45 cents, or 1 percent, at $46.10 in midday trading on the New York Stock Exchange.
