Abuse-resistant painkillers get mixed FDA response

oxycodone12.jpgWith painkiller addiction on the rise, drugmakers have come up with clever ways to discourage such behavior. As recently as 20 June, the US Food and Drug Administration (FDA) approved a new abuse-deterrent formulation of oxycodone called Oxecta, developed by Pfizer and Acura Pharmaceuticals of Palatine, Illinois. The new pill becomes gummy when crushed, making the oxycodone harder for addicts to extract as a powder and snort for a quick, potent high. “It lends itself less well to standard practices of laypeople trying to abuse it,” explains anesthesiologist Howard Smith of Albany Medical Center in upstate New York.

Devising a better painkiller is big business. Doctors wrote more than 200 million prescriptions for opioid medications in the US during 2009. Meanwhile, the number of people entering substance abuse programs for opioid addiction increased fivefold between 1998 and 2008, and a July 2010 report from the US Centers for Disease Control and Prevention points to painkillers as the leading cause of fatal drug overdoses.

But not every ‘abuse-deterrent’ design has received a regulatory thumbs-up. On 23 June, only a few days after the Oxecta approval, the FDA rejected Remoxy because of manufacturing problems. Remi Barbier, president and chief executive officer of Pain Therapeutics in Austin, Texas, which developed the drug with Pfizer, says the companies are now working to resolve those issues.

Remoxy combines a crush-resistant technology similar to that found in Oxecta with a time-release element, so the pill is “trying to do a lot all at once,” says Sidney Schnoll, vice president of pharmaceutical risk management services at Pinney Associates in Bethesda, Maryland. “These are difficult products to produce.”

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Image: by Flickr user Be.Futureproof under Creative Commons

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