|Wednesday, June 19, 2002
|4 to 5 more years of research needed in making painkiller less attractive to abusers
OxyContin substitute stalled
|In Southwest Virginia, more than 60 people have died from overdoses of the drug.
By LAURENCE HAMMACK
THE ROANOKE TIMES
The manufacturer of OxyContin, which has seen the painkiller's benefits eclipsed by reports of addiction and death, said Tuesday that development of an abuse-resistant alternative drug is taking longer than anticipated.
Purdue Pharma had hoped to submit a new opium-based painkiller for approval to the Food and Drug Administration by the end of the year.
But those plans have now been pushed back four to five years to allow additional research into the possibility of combining the active painkilling ingredient oxycodone with an antagonist, or a blocker that would make the drug less attractive to abusers.
"We are disappointed at this delay in our efforts to introduce a more abuse-resistant medication," said Paul Goldenheim, Purdue Pharma's executive vice president for research and development.
"Developing new medications that are safe and effective for patients in pain, and at the same time resistant to abuse, is a very complex scientific and technical challenge," Goldenheim said.
The Connecticut-based company has been working to develop a new painkiller since abuse of OxyContin surfaced several years ago. In Southwest Virginia, more than 60 people have died from overdoses of the drug's active ingredient, and authorities attribute rising crime rates to the drug's popularity among abusers.
Since it was approved by the FDA in 1995, OxyContin has been hailed as a miracle drug because of a formula that gradually releases oxycodone into a patient's bloodstream over 12 hours.
But it didn't take long for drug abusers to circumvent the time-release mechanism by chewing the tablets or crushing them and snorting or injecting the powder for an immediate, heroin-like high.
Purdue Pharma said last year that it was hoping to add the antagonist naloxone to rob intravenous abusers of the drug's high. Meanwhile, the company is also studying the introduction of a second antagonist, naltrexone, that would also render the painkiller useless to abusers who chew or inhale it.
The company said Tuesday that its research has found that metabolism of naloxone was more variable than expected among legitimate patients, raising concerns that pain relief might be compromised.
The setback with naloxone has prompted Purdue Pharma to shift its emphasis to the naltrexone formulation, company spokesman Jim Heins said. That formulation is seen as more promising, because its effectiveness would not be limited to intravenous abuse.
Under the proposal, naltrexone, which has been used as a treatment for alcoholism, would be coated with a chemical that would prevent it from dissolving. The antagonist would pass through legitimate patients, who would still benefit from the full dose of oxycodone over a 12-hour period.
But abusers who crush the pills would break up the coating and allow the naltrexone to enter the bloodstream, immediately counteracting any high the oxycodone would have produced.
The company said it will take at least five years to develop a naltrexone-based drug, which had been viewed as more complicated than the naloxone version.
Meanwhile, Purdue Pharma will continue to produce OxyContin, which accounted for $1.5 billion in sales last year.