FDA panels nix approval of abuse-deterrent oxycodone for pain
With a vote of 14-3, two FDA advisory committees have voted against recommending approval of abuse-deterrent (AD) oxycodone extended-release capsules (Remoxy ER—Pain Therapeutics) for severe pain.
With a vote of 14-3, two FDA advisory committees have voted against recommending approval of abuse-deterrent (AD) oxycodone extended-release capsules (Remoxy ER—Pain Therapeutics) for severe pain. A briefing document from the manufacturer said the company was seeking approval for the drug "as an analgesic with properties that can be expected to meaningfully deter the injection, snorting, and smoking routes of abuse." However, according to the Anesthetic and Analgesic Drug Products Advisory Committee and Drug Safety and Risk Management Advisory Committee, the evidence on the drug's efficacy, safety, and risk-benefit profile does not support the approval of its application. Panel member John B. Hertig, PharmD, associate director at the Center for Medication Safety Advancement at the College of Pharmacy, Purdue University, Indianapolis, explained: "I applaud the sponsor for being innovative and taking a step in the right direction but ultimately, when I'm balancing the risk-benefit and the availability of some similar options that are currently on the market compared with the possible public health impact, for me it was a no." The drug's data met current standards for AD labeling via the intranasal route, an FDA presenter at the meeting said, but the FDA lab determined that "oxycodone suitable for I.V. use" could be extracted from the drug in some circumstances. In addition to concerns about the AD data, other issues discussed in the meeting included public safety concerns and fears of another situation "reminiscent of Opana," for which nasal deterrence led to greater I.V. abuse. Thomas E. Prisinzano, PhD, of the University of Kansas School of Pharmacy, Lawrence—who voted to recommend approval—said "the company did meet the criteria for abuse deterrence in terms of intravenous and intranasal. And oral is always going to be a problem in this particular case." The FDA Advisory Committee Briefing Document for Remoxy ER is available <a href="https://www.fda.gov/downloads/AdvisoryCommittees/CommitteesMeetingMater…; target="_blank">here</a>.