<em>OxyContin</em>’s Abuse-Deterrent Claims Strong, But Stronger Claims Possible

OxyContin’s Abuse-Deterrent Claims Strong, But Stronger Claims Possible

22 Apr 2013

• By Cathy Dombrowski

FDA reviewed all the categories of pre-marketing and post-marketing data outlined by guidance for abuse-deterrent opioids, but only in vitro and liking studies made it into the updated label.

Purdue Pharma LP dodged generic competition to OxyContin (oxycodone controlled release) April 16 when FDA decided the original formulation is no longer a suitable reference product and gave the reformulation an abuse-deterrent claim, but brand products with potentially greater potential to deter abuse loom on the horizon to threaten the company’s long-acting oxycodone franchise.

qRevised labeling summarizes results from in vitro and clinical studies that show the drug is expected to make abuse via...