The FDA has cancelled this meeting because Purdue Pharma L.P. withdrew the related supplemental new drug application (sNDA). The committees were scheduled to discuss the results of post-marketing studies evaluating the misuse and/or abuse of reformulated OXYCONTIN (oxycodone hydrochloride) extended-release tablets, submitted by Purdue Pharma L.P. In particular, the discussion would have been about whether the post-marketing studies have demonstrated that the reformulated OXYCONTIN product has had a meaningful impact on abuse of OXYCONTIN.
Media reports stated that Dr. Richard Fanelli, the company’s head of Regulatory Affairs explained the decision in an email as follows, "Given the complexity of epidemiological research and the unprecedented nature of this exercise, we've made the decision to complete additional analyses.”
Tarius will monitor the Federal Register and other sources for any rescheduling or further announcements regarding this topic.