FDA WILL RESTRICT A NEW PAINKILLER

Stronger Than OxyContin, Purdue's Opioid Palladone Has a Potential for Abuse

The Food and Drug Administration approved a powerful long-acting
painkiller called Palladone, but the decision came with restrictions
designed to avoid the abuse and addiction problems that have arisen
with similar drugs.

The new drug is similar to OxyContin, a controversial medicine made by
the same company, closely held Purdue Pharma LP, and it has an active
ingredient that is even more potent. That has raised concerns about
the potential for abuse at a time when misuse of prescription drugs --
particularly painkillers -- is rising.

Purdue says Palladone has a different formulation from OxyContin,
which is available generically. It is a capsule, not a tablet, and has
a time-release function that should make it more difficult, though not
impossible, to misuse. Approved by the FDA in 1995, OxyContin became
widely abused partly because it could be crushed, unlocking the
time-release mechanism and delivering a potent high.

To reduce the risk of misuse, Palladone will have a phased rollout in
which Purdue will limit its promotion of the drug for the first 18
months, focusing initially on doctors who are highly experienced in
prescribing similar painkillers. "The goal is to ensure safe use of
the medication," said J. David Haddox, vice president for health
policy at Purdue. "We're trying to optimize the benefit-risk ratio for
this drug."

The restrictions generally match those suggested by an FDA advisory
committee that examined the concerns surrounding Palladone and similar
drugs last fall. They fall short of limitations urged at the meeting
by Drug Enforcement Administration officials and others concerned
about the potential for misuse, who had asked for the drug to be
labeled for use only in cases of "severe" pain.

There will be no restrictions on which doctors are allowed to
prescribe the drug or which pharmacies can carry it. It wasn't clear
that the FDA had the power to impose such restrictions.

Set to become available in the first half of next year, Palladone
contains an extended-release dose of the opioid hydromorphone,
designed to be taken once every 24 hours. In the FDA
advisory-committee meeting, an FDA official said hydromorphone may be
more appealing to addicts than OxyContin's active ingredient,
oxycodone. Dr. Haddox said he "doesn't think there's any evidence"
that hydromorphone has more "abuse liability" than similar drugs.

The plan for Palladone includes doctor education and efforts to track
whether the drug is diverted to illegal use, by surveying
law-enforcement sources, poison-control centers and other entities.
The drug also will come with a warning that says it should be used
only for "persistent moderate to severe pain in patients requiring
continuous, around-the-clock analgesia," and only in patients already
taking opioids.

Including OxyContin, sales of narcotic painkillers totaled $5.6
billion last year, up 20% from the year before, according to IMS
Health, a market-research company. An estimated 2.8 million people had
at some point used OxyContin without a medical need, according to a
2003 federal study. That was up from 1.9 million in 2002.