FDA Publishes Blog on Abuse-Deterrent Opioid Formulations

In a FDAVoice blog posted on Oct. 28, 2016, Douglas C. Throckmorton, MD, deputy center director for Regulatory Programs in FDA’s Center for Drug Evaluation and Research (CDER) gave an overview of some key facts on abuse-deterrent opioids. According to Throckmorton, FDA has approved seven opioid formulations with abuse-deterrent properties. Throckmorton said there are more formulations in the development pipeline. 

Abuse-deterrent opioids are defined as “tablets or capsules that are designed to deter abusers from crushing them into a powder for swallowing, snorting, or injecting to create a faster, more intense high.” Some formulations are tablets with hard surfaces that make it more difficult for abusers to crush them. Other tablets when crushed turn into a gooey substance that is difficult to inject or include naloxone, which blocks the effects of the opioid in the body.

Throckmorton noted that there may still be potential for abuse with these formulations. FDA requires that drugs approved with abuse-deterrent properties be further evaluated by manufacturers after they are marketed. Manufacturers are required to conduct additional studies to further evaluate the opioids. Throckmorton said FDA encourages the creation of abuse-deterrent formulations. The agency released a guidance in March 2016 and an opioid action plan in February 2016. Throckmorton said the agency’s goal is to “find a balance between appropriate access to opioids for patients in pain and the need to reduce abuse and misuse of these medications.”

Source: FDAVoice Blog