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Snag Delaying Development Of Abuse-Resistant OxyContin
Pubdate: Thu, 20 Jun 2002
Source: Deseret News (UT)
Copyright: 2002 Deseret News Publishing Corp.
Contact: http://www.desnews.com/
Details: http://www.mapinc.org/media/124
Author: Lauran Neergaard, AP medical writer
Bookmark: http://www.mapinc.org/oxycontin.htm (Oxycontin)
SNAG DELAYING DEVELOPMENT OF ABUSE-RESISTANT OXYCONTIN
WASHINGTON - An abuse-resistant form of the powerful but controversial
painkiller OxyContin won't be ready next year as its manufacturer had hoped.
The widely prescribed narcotic painkiller is considered important therapy
for many patients suffering long-term moderate to severe pain from cancer
or other illnesses. When swallowed whole, one tablet provides 12 hours of
pain relief.
But if chewed, inhaled or injected, OxyContin produces a quick - and
potentially lethal - heroin-like high. It has been linked to more than 100
deaths.
Manufacturer Purdue Pharma is trying to create abuse-resistant forms by
adding drugs that would block the buzz if OxyContin is taken the wrong way.
One method under consideration is to put the narcotic blocker naloxone in
OxyContin tablets. If the tablets are crushed and injected, naloxone would
enter the bloodstream to block the OxyContin's effects. That wouldn't block
other forms of abuse, but Purdue Pharma had called it an important interim
step that it hoped to begin selling next year. A competing painkiller,
Talwin NX, uses that approach.
But Tuesday, Purdue Pharma announced that clinical trials found, among
other problems, that naloxone sometimes blocked pain relief for patients
who took the combination tablets correctly. Purdue Pharma said it won't be
seeking Food and Drug Administration approval this year and will do further
research to see if naloxone is worth pursuing.
The company is focusing on another method: turning OxyContin into a capsule
that contains lookalike beads of the painkiller and another narcotic
blocker, naltrexone.
Swallow the capsule and only the OxyContin beads should dissolve, providing
proper pain relief. The hope is that if an abuser crushed all the beads -
chewing, injecting or snorting them - naltrexone would be released to block
the high.
Clinical trials could begin within a year, but complete testing will take
four or five years.
"While we're disappointed we won't have an abuse-resistant formulation on
the market next year as we had hoped . . . it is our highest priority,"
said Purdue Pharma research chief Dr. Paul Goldenheim.
Creating abuse-resistant painkillers is "very difficult and very complex,"
said Dr. Cynthia McCormick, FDA's chief of addictive products. "We haven't
seen to date any proposed formulation by any company that we would say is
absolutely, 100 percent effective in preventing abuse."
Some critics have called for OxyContin to be banned, at least until an
abuse-resistant version is developed. The FDA isn't considering that,
McCormick said, noting that other painkillers are abused, too.
On the Net: Food and Drug Administration: www.fda.gov
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