FDA Panel Nixes 'Abuse-Proof' OxyContin
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Todd Zwillich
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May 11, 2008 — A panel of expert advisors to the FDA took a dim view
Monday of efforts by OxyContin's manufacturer to market a new form of
the prescription painkiller designed to cut down on tampering and abuse.

The deliberations were a setback for the firm, Purdue Pharma. It was
stung a year ago when the company and three of its executives pleaded
guilty to illegally hiding the addictive potential of the drug, which is
a narcotic.

The company now wants to sell a new form of the drug coated in a
plastic-like polymer that prevents potential drug abusers from easily
grinding tablets into a fine powder. That makes it hard to snort the
drug or "cook" it for intravenous injection.

When it is "cooked," it forms a gelatin ball that is difficult to draw
into a syringe. But the coating does not affect how the tablets dissolve
in the gut, so patients would still be able to use the drug for pain
relief, the company said.

Sales and Abuse Up

Sales of oxycodone, including several generic forms as well as Purdue
Pharma's brand name OxyContin, have shot up since its extended-release
form was approved in 1996. According to the FDA, sales peaked at 42.2
million prescriptions last year, and with them abuse rates have also
gone up.

More than 12%% of 18- to 25-year-olds reported using the drug for
nonmedical reasons in 2006, according to federal figures. Those figures
also estimate that 500,000 Americans try oxycodone recreationally for
the first time each year.

Purdue Pharma officials tried to show that the polymer cut down on the
amount of active drug that an addict could extract from a tablet.

"We can argue that we have met some degree of tamper resistance. But the
abuse resistance is yet to be determined," said J. David Haddox, MD,
Purdue Pharma's vice president of risk management and health policy.

Data Criticized

But while experts supported the idea of tablets that are hard to misuse
while keeping OxyContin available for pain patients, they said the
company failed to show that the new form would cut down on abuse in the
real world.

The company did not show, for instance, whether motivated addicts with
some facility in chemistry would be able to find ways around the polymer
coating, experts said.

Panelist Lewis Nelson, MD, said the product could present doctors and
regulators with a "false sense of security" that oxycodone is now safe,
despite the fact that most overdoses follow the drug being swallowed orally.

"This new product doesn't bring any solution to the vast majority of
deaths that occur with this product," said Nelson, director of the
medical toxicology program at New York University School of Medicine.

At some points the criticism crossed over into ridicule. Jeffrey R.
Kirsch, MD, a member of the panel, said he was "fascinated" with the
"poor scientific rigor" or Purdue Pharma's claims that the new OxyContin
was truly tamper-resistant.

"Almost to the point of being insulting," added Kirsch, a professor of
anesthesiology from Oregon Health and Science University.

"The data presentation I would not allow in an honors undergraduate
thesis to go forward," added Ruth S. Day, PhD, a panelist from Duke
University.

The panel did not take any formal votes. But it was nearly unanimous
that Purdue Pharma should not be allowed to proceed with a plan to sell
lower OxyContin doses in the coated form while still selling higher, 60-
and 80-milligram doses in the original form.

Doing so would confuse physicians and drive addicts to seek out the old
forms of the drug, experts said.

In a statement, the company said it "will continue to work with the FDA
on our New Drug Application (NDA) for a new formulation of OxyContin
(oxycodone HCl controlled-release) Tablets."

"Untreated and undertreated pain is a serious public health issue in the
United States," the statement said.

Three Purdue Pharma executives and the company agreed to pay a combined
$634.5 million in fines after pleading guilty to illegally promoting
OxyContin to doctors and withholding data on its abuse potential.

SOURCES: National Survey on Drug Use and Health, 2006, Substance Abuse
and Mental Health Services Administration; J. David Haddox, MD, vice
president, risk management and health policy, Purdue Pharma; Lewis
Nelson, director, medical toxicology program, New York University School
of Medicine; member, FDA panel; Jeffrey R. Kirsch, professor of
anesthesiology, Oregon Health and Science University; member, FDA panel;
Ruth S. Day, PhD, Duke University; member, FDA panel; Statement, Purdue
Pharma.