FDA panel recommends approval of new OxyContin formulation

**Justin** · 09-25-2009, 02:27 PM

FDA panel recommends approval of new OxyContin formulation
Copyright © 2009 by Custom Briefings

The AP (9/25, Perrone) reports, "Federal health advisers on Thursday recommended approval for a new version of the painkiller OxyContin [oxycodone] that is designed to be harder to abuse." In a 14-4 vote, "a Food and Drug Administration panel of experts" backed "the reformulated OxyContin from Purdue Pharma." They also recommended, however, that "the company be required to conduct a follow-up study to track patients taking the drug over the long term."

The drug's original formulation allows it to be crushed or dissolved in water and then injected, immediately releasing all of its effects, the Dow Jones Newswire (9/25, Dooren) reports. But, "the new version contains a chemical additive that reduces the amount of medicine released when the pills are chewed or crushed, according to an FDA staff review," Bloomberg News (9/25, Wechsler, Larkin) reports. These "'limited' tamper-resistant properties may provide an advantage in reducing misuse or abuse," regulators said.

MedPage Today (9/24, Walker) reported, however, that "there is no proof that the new formulation is safer." Still, "the panel agreed that making the pills harder to crush, chew, or dissolve into liquid may deter abusers." If the new formulation is approved, "Purdue will produce only the newer version and stop shipping the old one."