Government advisers voiced skepticism Monday that a new version of the potent painkiller OxyContin would live up to its maker’s claim of being harder to abuse.
Purdue Pharma LP contends that adding a plastic-like coating to the tablets makes the drug sometimes called “hillbilly heroin” harder to crush and snort or inject.
But advisers to the Food and Drug Administration called for more testing.
“What we heard from the committee was that they have a lot of concern that the formulation had not been adequately evaluated,” said FDA’s Dr. Curtis Rosebraugh.
The FDA didn’t ask the advisory panel to formally vote on whether the new OxyContin version should be approved for sale. Instead, the agency asked for input on its own concerns — such as as how much evidence is needed before a product can be sold as a tamper-resistant, if far from tamper-proof, version, and whether the version could backfire.
The FDA isn’t bound by the panel’s advice but typically follows it.
OxyContin is a time-release version of the old narcotic oxycodone, designed to be swallowed whole and digested over 12 hours to keep a steady state of the painkiller in the bodies of seriously ill patients. While doctors call it an important option for many patients, abusers rapidly discovered the tablets can produce a heroin-like high if crushed to get the dose all at once.