MORE RESEARCH ON ABUSE-RESISTANT OXYCONTIN NEEDED

WASHINGTON - The maker of the controversial painkiller OxyContin announced
Wednesday that it must conduct additional studies in order to seek US
approval of an abuse-resistant formulation of the drug.

OxyContin, made by Purdue Pharma LP, is a sustained-release painkiller most
commonly used to treat patients suffering from severe pain caused by cancer
and other illnesses. Used appropriately, the drug provides about 12 hours
of relief. But if crushed and swallowed, inhaled or injected, the drug
produces a potentially life-threatening heroin-like high that has led to
its abuse.

According to the US Drug Enforcement Agency (DEA), abuse of OxyContin has
been implicated in 146 deaths and is associated with another 318 deaths,
for which there is insufficient data to establish the drug's role.

Stamford, Connecticut-based Purdue Pharma originally was expected to file
for approval of the abuse-resistant formulation with the US Food and Drug
Administration (FDA) by the end of 2002.

The formulation would have combined OxyContin with the opioid-blocking drug
naloxone to prevent intravenous abuse. The formulation was not expected to
help prevent or deter those crushing and then snorting or swallowing the
tablet, the more commonly reported forms of abuse associated with the
painkiller.

The company said the delay was caused by concerns that the new formulation
might not always provide sufficient pain relief or low enough doses to
deter abuse. The firm said the concerns emerged from early-stage studies,
in which it was shown that the absorption or metabolism of naloxone is more
variable than previously anticipated.

Purdue Pharma spokesman James Heins told Reuters Health that the company
would continue to evaluate the potential use of naloxone, but would now
focus the majority of its efforts on antagonists with the potential to
prevent other forms of abuse as well, including chewing and snorting.

"We had hoped that naloxone would be an interim solution," he told Reuters
Health. "But why put all that effort into a product with limited potential?"

Still, Heins said the launch of any such abuse-resistant product would now
take at least 4 to 5 more years since naloxone was the company's most
advanced clinical program.

Besides naloxone, the company is also researching the potential combination
of OxyContin with naltrexone, a drug commonly used to treat alcohol abuse.

Purdue noted it has spent more than $100 million over the past 2 years on
development of abuse-resistant formulations and now expects to spend
considerably more before the project is completed.