Abuse-Deterrent Opioid Claims Need Studies, Studies And More Studies
This article was originally published in Pharmaceutical Approvals Monthly
Executive Summary
FDA’s review of Purdue’s Targiniq ER, one of only two opioids with approved abuse-deterrent claims, shows that the agency’s skepticism about the state of the technology to deter opioid abuse can be overcome – by an exhaustive set of comparisons in clinical, in vitro and PK studies.