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