FDA reviews new OxyContin formula

Bloomberg News / September 23, 2009

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WASHINGTON - Proposed changes to the painkiller OxyContin “may provide an advantage’’ by reducing the chances of misuse or abuse, according to US regulators.

Closely held Purdue Pharma LP has applied to reformulate the pill so not as much medicine is released when it is chewed or crushed, Food and Drug Administration staff said in a report posted on the agency’s website. Outside advisers to the agency will meet tomorrow to discuss the findings and whether the new product should be approved. The FDA has encouraged drug makers to introduce new long-acting painkillers that can’t be manipulated for a quick high. The agency’s review shows that Purdue has moved ahead of King Pharmaceuticals Inc. in the race to reformulate oxycodone, the narcotic in OxyContin.

“The tamper-resistant properties of the reformulated OxyContin are limited,’’ James M. Tolliver, a pharmacologist with the FDA’s Controlled Substance Staff, wrote. “However,’’ they “may provide an advantage over the currently available OxyContin.’’

Purdue, of Stamford, Conn., plans to replace its existing supply of OxyContin with the new OxyContin-TR formula if it is approved, according to the FDA.