FDA Offers Draft Guidance for Developing Abuse-Deterrent Opioids

Drug manufacturers developing opioids with abuse-deterrent properties should use three categories of premarket studies to provide enough data on a drug’s prospects for reducing abuse or misuse, according to new draft FDA guidance. The agency believes new technology that effectively deters abuse is important to incentivize, and the guidance is part of an array of components to prevent misuse and abuse of opioids, Douglas Throckmorton, deputy director for CDER’s regulatory programs, said in a conference call Wednesday.
Drug Industry Daily