The Food and Drug Administration has approved a new version of the painkiller OxyContin designed to be harder for patients to abuse, but one of the regulator's doctors said it may offer only "an incremental advantage."
OxyContin treats severe chronic pain as a time-release version of the narcotic oxycodone. It is designed for use over 12 hours, to maintain a steady state of pain relief for seriously ill patients.
However, drug abusers quickly discovered they could get a heroin-like high by crushing the pills and snorting or injecting the dose. The new pill uses a coating designed to make the drug harder to crush and snort or inject.
The FDA's Monday decision follows a vote last fall by its panel of experts in favor of the reformulated drug, which is made by Purdue Pharma of Stamford, Conn.
"Although this new formulation of OxyContin may provide only an incremental advantage over the current version of the drug, it is still a step in the right direction," said Dr. Bob Rappaport in a statement from the FDA. Rappaport is director of the Division of Anesthesia and Analgesia Products in the FDA's Center for Drug Evaluation and Research.
Purdue Pharma will be required to study whether the new formulation of the drug reduces its abuse.
