Does Purdue’s Reformulated OxyContin ER Really Deter Abuse? US FDA Panel To Decide

Five years after an advisory committee meeting was cancelled, panel will consider whether required postmarketing studies show Purdue’s reformulated opioid ‘meaningfully’ reduces abuse and overdose.

October 21, 2018: Ogden Utah USA- OxyContin bottles sit on counter which is a famous drug in the current news for causing overdose and addiction P — FDA advisory committee to review OxyContin ER abuse deterrent data • Source: Shutterstock

Two US Food and Drug Advisory Committees will finally get to look at postmarket data to determine whether Purdue Pharma L.P.’s reformulated OxyContin actually deters abuse and misuse. The analysis could have an impact on other opioids with abuse-deterrent labeling as it will give an indication of what postmarket studies must show for products to retain the claim.

Reflecting the importance of the review and the extent of data, both the FDA’s Drug Safety and Risk Management Advisory...