FDA Advisers Back New OxyContin Pill
U.S. health advisers on Thursday recommended approval of a new version of the painkiller OxyContin that is designed to lessen its misuse.
The U.S. Food and Drug Administration's panel of experts voted 14-4 in favor of the reformulated Purdue Pharma drug, which has a plastic-like coating that makes it harder to crush or dissolve in water.
But the experts also recommended the company be required to conduct a follow-up study to track patients taking the drug over the long term, the Associated Press reported.
The FDA is not required to follow its experts' advice, though it usually does.
OxyContin was hailed as a breakthrough treatment for severe chronic pain when it was introduced in 1996. But drug abusers quickly discovered they could get a heroin-like high by crushing the pills and snorting or injecting them.
On Tuesday, FDA scientists called the new version's resistance to abuse "limited," but said that "may provide an advantage over the currently available OxyContin."
Last year, an FDA advisory panel told Purdue that it needed to conduct more tests to demonstrate the tamper resistance of the new version.
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