FDA Panel Rejects Vioxx-Like Pain Drug

A federal advisory panel on Thursday rejected Merck's bid
to market a new osteoarthritis medication similar to Vioxx, a drug the company
pulled from the U.S. market in 2004 because it put patients at risk for heart
attacks and strokes.

The decision, delivered in a 20 to 1 vote, makes it highly unlikely that the
FDA will approve the drug, called Arcoxia.

Arcoxia is in the class of nonsteroidal anti-inflammatory drugs (NSAIDs)
known as Cox-2 inhibitors, which includes Vioxx and Bextra -- both removed from
U.S. pharmacies -- as well as Celebrex, which is still on the market. Cox-2
drugs have a lower risk for stomach ulcers and gastrointestinal bleeding than
other NSAIDs such as aspirin and ibuprofen.

Arcoxia has been sold for the last five years in Europe and in dozens of
countries around the world. The drug represented Merck's first attempt to
return to the once-lucrative Cox-2 pain drug market in the U.S.

The company had hoped to convince experts that the drug was a better pain
drug than related drugs -- and also that it was safer.

"Patients with osteoarthritis want and deserve additional treatment
options," said Scott Korn, MD, Merck's executive director of regulatory
affairs.

But experts and some FDA officials criticized Merck for using poorly
designed scientific studies in an attempt to put Arcoxia in the best possible
light.B

Panel member David Felson, MD, noted that more than roughly 20 nonsteroidal
anti-inflammatory drugs are already on the market.

"A new drug has to have some reason why you would put it in the top six
of your rotation or it's not going to have much of an effect," said Felson,
a professor of medicine at the Boston University School of Medicine.

After hearing Merck's results, Felson said he'd concluded that "20 is
enough."

Robert Shibuya, an FDA medical officer, told experts that studies in nearly
4,000 patients left "little doubt" that Arcoxia is an effective pain
reliever. But in question was the drug's potential, like similar drugs, to
increase risk for cardiovascular problems like heart attacks and stroke in
millions of potential users.

Heart Risks

FDA Safety Officer David Graham, MD, presented an analysis estimating that
every 1 million patients would cause between 6,800 and 30,000 additional heart
attacks per year if they were treated with Arcoxia instead of a widely
available older NSAID, naproxen (brand names include Aleve and Naprosyn).

"What you're talking about is a potential public health disaster,"
said Graham, who played a key role in publicizing safety problems with other
Cox-2 drugs in 2004. "And then we'll have a repeat of what we had with
[Vioxx]."

In a statement released after the vote, a Merck official said the company
was disappointed in the panel's recommendation. Peter Kim, PhD, president of
Merck Research Laboratories, said, "We are committed to continuing to work
with the FDA to discuss the application in an effort to gain U.S. regulatory
approval for Arcoxia."

By Todd Zwillich
Reviewed by Louise Chang
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