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SILVER SPRING, Md. — One of the most serious drug abuse problems in the country doesn't involve heroin, methamphetamine or crack, but abuse of legal prescription drugs, particularly opioid painkillers, a problem that the Food and Drug Administration aims to change with draft guidance released Wednesday.
In August 2010, Purdue Pharma introduced an abuse-deterrent formulation of OxyContin (oxycodone) extended-release tablets, and Endo Pharmaceuticals received FDA approval for its crush-resistant version of Opana ER (oxymorphone) in December 2011. Both drugs, long popular targets for abusers, are designed to become ineffective after crushing, a method used by abusers who then snort or inject them.
To date, however, FDA-approved drug labeling has not included language about abuse deterrence, nor has the agency given anyone the claim of reduced abuse liability. But in the new draft guidance, the agency explains its current thinking about the studies it said companies should conduct to demonstrate that a given formulation of an opioid drug has abuse-deterrent properties, how the agency will evaluate the studies and what labeling claims may be approved. The agency said it would seek public comment on the guidance over the next 60 days.
"The agency believes that new technologies that are effective to reduce abuse are very important for us to incentivize," FDA Center for Drug Evaluation and Research deputy director for regulatory programs Douglas Throckmorton said in a conference call with reporters. "It's the reason we are putting out this draft guidance today."
The FDA's announcement comes amid a problem that has seen tremendous growth in the past several years. According to the Centers for Disease Control and Prevention, 2 million people reported abusing prescription painkillers for the first time within the last year, with 71.6% of those obtaining, buying or stealing them from friends or relatives. Misuse and abuse of prescription painkillers led to more than 475,000 emergency room visits in 2009, a figure that nearly doubled over the course of five years, and the drugs were involved in 14,800 overdose deaths in 2008 — more than cocaine and heroin combined.
With abuse comes related violent crime: According to the Drug Enforcement Administration, armed robberies of pharmacies jumped 81% in the five years leading up to 2011. That has prompted efforts like RxPatrol, established by Purdue Pharma as a way to collect and share pharmacy crime data between pharmacies and law-enforcement agencies.
Studies have indicated that adding abuse-deterrent features can reduce abuse of the opioids that have them, but can also steer drug abusers toward other opioids, legal and illegal. According to one 2,566-patient study conducted last year by researchers at Washington University in St. Louis and Nova Southeastern University in Florida, the number of drug abusers who abused OxyContin fell from 35.6% to 12.8% after the introduction of the abuse-deterrent version, while abuse of such opioids as hydrocodone and other oxycodone formulations rose slightly, and abuse of high-potency fentanyl and hydromorphone rose significantly, from 20.1% to 32.3%. Of all opioids used at least once to get high in a 30-day period, OxyContin fell from 47.4% to 30%, but heroin use nearly doubled. The study also found that while 24% found a way to defeat the abuse-deterrent properties of the new version of OxyContin, 66% indicated that they had switched to another opioid, most commonly heroin.
“Our nation is in the midst of a prescription drug abuse epidemic,” Office of National Drug Control Policy director Gil Kerlikowske said. “While there are no silver bullet solutions to this public health and safety challenge, abuse-deterrent formulations of powerful prescription opioids can make a difference in addressing this epidemic. This guidance is a vital component of the administration’s comprehensive effort to reduce prescription drug abuse in America, and we commend the FDA for its commitment to this challenge.”