FDA Rejects Merck's Request
To Market Osteoarthritis Drug
Associated Press
April 27, 2007 9:46 a.m.
WHITEHOUSE STATION, N.J. -- Merck & Co. says the Food and Drug Administration turned down its request to market its planned successor to Vioxx, osteoarthritis drug Arcoxia, in the U.S.
Arcoxia is on the market in 63 countries, and Merck said the drug would provide another treatment option for arthritis patients in the U.S. who can't tolerate other pain medications.
"We are disappointed with today's decision," said Peter S. Kim, president of Merck Research Laboratories.
Vioxx was pulled off the market in September 2004 after it was linked to an increased risk of heart attacks and strokes, and in 2005, the FDA asked Pfizer Inc. to pull Bextra off the market. Pfizer was allowed to keep its other so-called Cox-2 painkiller, Celebrex, on the market with warnings.
The FDA directly acknowledged that the Vioxx withdrawal has increased scrutiny from "all quarters" on cardiovascular risks associated with Cox-2s and other prescription pain drugs. The agency said the approval of a new Cox-2 product "must be undertaken with due care and caution."
Drugs such as Celebrex and Arcoxia, which also fall into the broader NSAID class, are designed to block the Cox-2 enzyme in order to relieve pain without causing as many stomach problems as other NSAIDs that also block the Cox-1 enzyme.
In regard to Arcoxia, the FDA appeared to agree with Merck's conclusion that the cardiovascular risks of Arcoxia were similar when compared to an older NSAID, diclofenac. The two drugs were studied in three trials.
The studies found that patients on Arcoxia suffered fewer upper gastrointestinal problems like ulcers. However, the FDA said the rate wasn't statistically significant. |
