Addicts circumvent OxyContin's time-release mechanism by crushing the pills
Drug maker to change recipe
Purdue Pharma has spent millions researching ways to make a medication that cannot be converted into a street drug.
By LAURENCE HAMMACK
The Roanoke Times
The maker of OxyContin, which has seen the painkiller's benefits overshadowed by reports of addiction and death, announced Wednesday that it is developing a new drug that would be resistant to abuse.
If the new formula proves successful, it would preserve the drug's potent painkilling ability while adding a new ingredient - a second drug that would counteract the first one only when the pill is crushed into a powder and then snorted or injected.
Since Purdue Pharma learned that OxyContin was being abused, the company has spent millions researching ways to make an opium-based medication that cannot be converted into a street drug.
"Preliminary results appear to show some progress," the company said in a statement Wednesday. However, it could take up to three years for the new drug to undergo clinical studies and receive approval from the Food and Drug Administration.
Meanwhile, OxyContin will remain on the market.
Although Wednesday's announcement is not expected to affect lawsuits against Purdue Pharma or efforts by law enforcement to restrict illegal use of the drug, pain management experts said it might reduce some of the stigma they say has been unfairly associated with OxyContin.
"I really hope it will put some reason back into the furor that's going on right now," said Dr. J.K. Lilly of West Virginia, co-chair of the Appalachian Pain Foundation, an organization that advocates pain management in an eight-state region.
Since it was approved by the FDA in 1995, OxyContin has been hailed as a miracle drug due to a time-release formula that gradually releases its active ingredient, oxycodone, into a patient's bloodstream over 12 hours.
But it didn't take long for addicts to circumvent the time-release mechanism by crushing the pills and then inhaling the powder or mixing it with water and injecting it.
The results have been devastating in Southwest Virginia, where more than 35 people have died from oxycodone overdoses amid soaring crime rates.
Although Purdue Pharma disputes the number of fatal overdoses attributed to its product, it has developed a 10-point plan of action to prevent abuse that includes research of a so-called smart pill that would not appeal to abusers.
The proposal announced Wednesday entails adding microscopic amounts of naltrexone, a narcotic antagonist that is capable of canceling the effects of oxycodone or another opium-based drug that might be the new medication's active ingredient.
The naltrexone would be coated with a chemical that would prevent it from dissolving, allowing the painkiller's active ingredient to work in the same way it does with OxyContin.
But crushing the pill would break up the coating and allow naltrexone into a user's bloodstream, eliminating the heroin-like high produced by large amounts of oxycodone.
Naltrexone, which was approved by the FDA as a treatment for alcoholism, might actually cause severe withdrawal symptoms if the user has been taking oxycodone for some time, Lilly said.
But as long as the formula ensures that naltrexone remains dormant when the drug is taken properly, Lilly said, Purdue Pharma's announcement is good news.
"It puts the risks back in the right place," he said. "It puts the risks on the abuser and not on the legitimate user."
According to Purdue Pharma, tests have shown that less than 5 percent of the naltrexone included in the drug has been released into a patient's bloodstream over 36 hours. The rest of the antagonist remains cloaked as it passes through the digestive system.
Company spokesman Jim Heins said that while the new formulation has been in the works for some time, recent advancements prompted the company to apply for a patent.
If the drug is approved, Heins said, it could be used as an alternative to OxyContin in high-risk areas such as Southwest Virginia.
Critics said that while long-term solutions are welcome, more needs to be done right away.
"The effort to reformulate is itself a recognition of the profound perils inherent in the drug," said Connecticut Attorney General Richard Blumenthal, who earlier this week called on Purdue Pharma to restrict marketing and distribution of its best-selling product.
"Announcing a patent application may portend a long-term solution, and it may be good public relations, but it has no immediate practical effect," Blumenthal said in a prepared statement. "Purdue Pharma has a moral, if not legal, obligation to take effective steps now that address addiction and abuse even as it works to reformulate the drug."