WASHINGTON -- The FDA has approved a new formulation of the opioid painkiller oxycodone hydrochloride (OxyContin) that is intended to reduce the potential for abuse of the drug.
The new tablet, which does not change the potency or the dosing recommendations, was specifically designed so that it cannot be easily cut, broken, chewed, crushed, or dissolved.
During a briefing call with patient advocates and other stakeholders, Robert Rappaport, MD, director of the FDA's Division of Anesthesia and Analgesic Products at the Center for Drug Evaluation and Research, explained that the new tablet cannot be crushed or chopped into small pieces by the methods most commonly used and "as such, it is also less likely to be abused by snorting."
But while the new tablet is expected to cut down on oxycodone abuse, Rappaport said it was unlikely to completely prevent it.
"Both the Agency review team and the experts at the September 2009 advisory committee supported approval of this application. This is because we believe even an incremental change that results in a reduction in abuse and misuse is a step in the right direction," he said.
The new tablet will be marketed as a switch-out for the old tablet "so both will not be sold," Rappaport said. And he said there would be no labeling changes.
Specifically, Purdue Pharma, maker of OxyContin will not be permitted to market the tablet as tamper resistant.
"Labeling has not changed substantially, and no marketing claims are allowed that would state this product is abuse deterrent or safer," he said. Because the drug was approved as a timed-release painkiller, original marketing of OxyContin did include safety claims that Rappaport said, led to "widespread overprescribing of the original formulation."
Rappaport signaled the FDA's intent to keep a close eye on the new tablet, noting that Purdue is required to conduct a postmarketing study and that the FDA planned to convene an advisory panel to review the protocol for that study.
He also explained that the FDA will use the Risk Evaluation and Mitigation Strategy (REMS) developed for Covidien's hydromorpone ER (Exalgo) as an interim REMS for the new oxycodone tablet.
In fact, Rappaport said, that REMS would be used as the standard REMS for all long-acting/extended-release opioids until the FDA can finalize a classwide REMS document.