Abuse-Deterrent Opioids Could Gain Significant First-Mover Advantage Under FDA Guidance

Sponsors of new abuse-deterrent opioids will be judged against their competitors, final FDA guidance indicates, as the agency works to determine whether that product has met the threshold for an abuse-deterrent labeling claim.

“As with all NDA products, FDA intends to consider opioids with abuse-deterrent properties within the context of available therapy,” the...