PURDUE PHARMA IS ORDERED TO SUSPEND NEW PAINKILLER

Purdue Pharma LP agreed to pull its powerful new painkiller Palladone
from the market because of evidence that, when taken with alcohol, it
could cause serious and sometimes fatal reactions.

The Food and Drug Administration, which asked Purdue Pharma to
suspend sales of the drug, said it hadn't received reports of major
problems since the drug went on the U.S. market in February. The FDA
said data from a Purdue Pharma study showed that, when Palladone
capsules were combined with even a relatively small amount of
alcohol, the mechanism ensuring the drug is released gradually over
24 hours could be disabled.

As a result, patients could get the full effects of Palladone's
active ingredient, the potent narcotic hydromorphone, all at once,
leading to problems including depressed or stopped breathing, coma or
death. Even for the lowest marketed dose of the drug, the FDA said,
it could prove fatal.

The agency said a Purdue Pharma study in 24 healthy men showed that
with a low dose of Palladone, concentrations of hydromorphone in the
blood could be 5.5 times higher when it was taken with eight ounces
of a 40%-alcohol solution.

The move is the latest in a series of recent actions by the agency
pressing a tough line on drug safety matters. Palladone held "no
unique benefit other than its convenience," and the FDA believed that
a label warning wouldn't eliminate the risk that the drug might be
taken with alcohol, said Robert Meyer, an FDA office director.
Palladone already had a strong label warning against the use of alcohol.

The agency also said it planned to review other drugs with
time-release mechanisms -- beginning with other painkillers, but also
including other drugs -- to determine whether there could be similar
problems when they interact with alcohol. Purdue Pharma said about
11,500 patients had been prescribed Palladone, which was being rolled
out gradually in the U.S. market to reduce the risk of abuse, but a
sales figure wasn't immediately available.

For closely held Purdue Pharma, the suspension is a serious blow. The
company counted on Palladone to replace its blockbuster drug
OxyContin, which faces generic competition. OxyContin, also a
painkiller, was widely abused by people who deliberately disabled its
time-release structure to get a high. The company said it might try
to bring Palladone back for use in restricted settings, such as
hospitals, and also was working to reformulate it to eliminate the
problem with alcohol.

A spokesman for Purdue Pharma said the FDA's call for a market
suspension was "unanticipated," but the company "complied with their
request." Purdue Pharma submitted data to the agency from human tests
with alcohol last November, before the drug went on the market, and
believed the label warnings "would be sufficient," the spokesman
said. The company said it submitted new data to the FDA in June from
a later test, but it was told this wasn't the basis for the
suspension request. The tests were done voluntarily as part of Purdue
Pharma's efforts to pinpoint ways the drug might be abused.

The FDA's Dr. Meyer said the data from human tests with alcohol that
the agency received before Palladone went on the market were
preliminary. The FDA got final results later and wanted to take
action before the drug was widely available, he said. Though lab
tests had shown there was a potential for Palladone's time-release to
be disabled when exposed to alcohol, he said, the agency was
surprised at the serious side effects when people took both the drug
and alcohol.

- Gary Fields contributed to this article.
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