FDA Debates New Version Of OxyContin

WASHINGTON (AP) - The government is evaluating a new version of

OxyContin - the potent painkiller sometimes called "hillbilly

heroin" - designed to be harder to abuse.

A plastic-like coating fuses to the tablet, making it harder to

crush - and turning into a gooey mess if abusers try to inject it,

maker Purdue Pharma LP said in documents released by the Food and

Drug Administration Thursday.

The FDA will ask its scientific advisers on Monday if the

reformulated drug seems tamper-resistant enough to allow on the

market, before the required long-term studies are done to see if

the changes thwart at least some abuse.

"These are clearly difficult questions for which there are no

easy answers," Dr. Bob Rappaport, FDA's chief of painkilling

drugs, wrote the advisory panel.

OxyContin was hailed as a breakthrough in the treatment of

severe chronic pain when it was introduced in 1996. A time-release

version of the old narcotic oxycodone, it was designed to be

swallowed whole and digested over 12 hours to keep a steady state

of the painkiller in the bodies of seriously ill patients.

But abusers rapidly discovered the tablets can produce a

heroin-like high if crushed and snorted or injected, thus dumping

the dose all at once instead of letting it seep in slowly.

The U.S. Drug Enforcement Administration found the number of

oxycodone-related deaths nationwide had quintupled by 2001, as

OxyContin prescriptions soared. The DEA cracked down, but OxyContin

abuse steadily spread across the country. And a year ago, Purdue

Pharma and some of its executives pleaded guilty to misleading the

public about OxyContin's risk of addiction earlier in the decade,

and agreed to millions in fines to settle state complaints that it

encouraged over-prescribing of the drug.

Against that contentious backdrop, the FDA had urged drug

companies to develop more abuse-resistant versions of important

painkillers, recognizing, in Rappaport's words, "the importance of

maintaining the availability of these important drug products for

the millions of patients in this country who suffer from chronic

pain."

The remade OxyContin marks the first application for a

reformulated painkiller that purports to do that, he wrote.

Purdue Pharma said its laboratory studies show the new OxyContin

is equivalent to the original in how well the painkiller dissolves

if used correctly.

If someone tries to crush it, the plastic-like coating makes the

tablet more likely to break into large fragments instead of a

powder, the Stamford, Conn.-based company wrote. The coating

renders the drug "a gelatinous mess" when mixed with alcohol or

other solvents in attempts to dissolve and inject it, the documents

say.

But the FDA cited concerns, including:

-Some people who died from OxyContin abuse swallowed the drug

without crushing it. Would the new version mislead doctors or

patients into thinking OxyContin is less risky than it really is?

-Lower doses are set to be reformulated initially, with higher

doses converted in the future. Does that increase risk from the

higher doses in the meantime?

Moreover, "there is no perfect formulation that can resist all

forms of tampering," FDA's Rappaport wrote. If approved, the new

version's label "would have to be carefully crafted so as to avoid

the publication of a road map describing how to defeat these

changes."

Two other companies, Pain Therapeutics Inc. and King

Pharmaceuticals, also are developing an abuse-resistant form of the

drug. Called Remoxy, it would provide a thick gelatin-like version

of oxycodone.

(Copyright 2008 by The Associated Press. All Rights Reserved.)


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