Pubdate: Sun, 10 Mar 2002
Source: Sunday Gazette-Mail (WV)
Copyright: 2002, Sunday Gazette-Mail
Contact:  http://sundaygazettemail.com/
Details: http://www.mapinc.org/media/1404
Author: Greg Stone
Bookmark: http://www.mapinc.org/find?186 (Oxycontin)

REMIX COULD BE TRICKY, OXYCONTIN'S MAKER SAYS

Reformulating OxyContin to make it less attractive to abusers won't be 
easy, says the manufacturer's medical director.

David Haddox, medical director for Purdue Pharma, indicated at a Washington 
think tank panel that reformulating the drug is an uncertain enterprise.

Haddox appeared last month before a panel hosted by the American Enterprise 
Institute, a collection of conservative, pro-business academics. He said 
the addition of an anti-euphoric agent such as naloxone or naltrexone to 
OxyContin could short-circuit the pain-relieving qualities of the drug, if 
the formulation is not carried out correctly.

Purdue heralded in December its plans to make OxyContin less attractive to 
abusers, by combining it with one of the other neutralizing agents. It 
carried the news on its Web site.

"When taken as directed, the oxycodone-naloxone tablet is intended to be 
swallowed whole, and the small amount of naloxone should not adversely 
affect the patient or interfere with the analgesic effect of the 
oxycodone," the news release says.

The release goes on to say that if the tablet were to be crushed or 
injected - the preferred methods of abuse - the naloxone would be released 
into the blood and counteract the effects of the oxycodone.

Haddox sounded much more cautious about the addition of the other 
medicines, both before the panel and in a subsequent phone interview.

"The process of drug development is not a slam dunk, especially when trying 
to do something new like this," Haddox said in the interview.

OxyContin has been blamed by medical examiners across the country for more 
than 100 deaths, based on the autopsy citations of oxycodone as the cause 
of death. Of all painkillers that contain oxycodone, OxyContin carries by 
far the largest concentration of the substance, coming in tablets as large 
as 80 milligrams. Percocet, by comparison, contains only 5 milligrams of 
oxycodone.

Some patients in genuine pain praise the drug as providing continuous, 
uninterrupted relief. Addicts, on the other hand, crush and snort or inject 
the drug, circumventing its time-release aspect and spurring a euphoric high.

West Virginia Attorney General Darrell McGraw sued Purdue Pharma last June, 
charging the company with "coercive and deceptive" marketing to physicians. 
The company is also facing several class-action suits from people who have 
become addicted.

That suit is stalled, said deputy managing attorney general Fran Hughes. 
The attorney general's office is awaiting a ruling by U.S. District Judge 
David A. Faber as to whether the suit should be remanded to state court.

State Sen. Truman Chafin, D-Mingo, introduced a bill earlier this 
legislative session that would make OxyContin a Schedule I drug, 
effectively outlawing it in West Virginia. Schedule I drugs have no 
accepted medical use.

In the midst of the turmoil, Purdue says it will try to reformulate the 
drug by adding one of the compounds.

Haddox says arriving at an appropriate amount of naloxone is complicated by 
the high absorption of the drug into the liver, and knowing how much of the 
anti-opioid compound to use.

"If you put in too little it may not work as we intended," Haddox said. "If 
you put in too much it may reduce the pain relief for the person with 
legitimate need."

Naltrexone appears to be the better choice at this point, Haddox said, 
because it is better absorbed into the blood. He said the drug might be 
coated with insoluble naltrexone.

If the drug is taken properly, Haddox said, the naltrexone would pass 
through the digestive tract unreleased into the blood. If the beads are 
broken, the naltrexone would rush into the bloodstream.

"That one looks pretty good in the lab right now," said Haddox.

Haddox said Purdue is not backing away from its announcement to reformulate 
the drug. He said if everything goes smoothly Purdue should have a new drug 
application to submit to the Food and Drug Administration by the end of the 
year.

One of Purdue's chief critics, St. Charles, Va., physician Art Van Zee, 
applauds the company's reformulation efforts. Nevertheless, he believes the 
drug should be taken off the market until that development occurs.

Van Zee has testified twice before Congress about the devastating effects 
OxyContin has had on his community.

"I've heard Haddox say several times that it's a technically challenging 
problem for them to do, which I don't dispute at all," Van Zee said. "I 
think it's much to their advantage in the long term if they can come up 
with it. I don't see any advantage to them to delay in doing this."
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