FDA Focuses on Abuse-Deterrent Opioids in Public Meeting

A public meeting will be conducted July 10-11 that will focus on opioids with abuse-deterrent properties, according to a statement issued by FDA Commissioner Scott Gottlieb, MD.

Gottlieb noted that the discussion will focus on whether there is enough research and information regarding whether these formulations actually limit abuse and help curb the addiction epidemic.

Abuse-deterrent opioids are designed to make their drugs difficult to manipulate by consumers to receive a high from the drug, like crushing a pill or melting the tablet into a liquid form for injection. However, Gottlieb noted that the phrase abuse-deterrent is not synonymous with abuse-proof. Officials with the FDA noted this this public meeting is designed to bring new ideas to the table on how to combat drug addiction in the most effective way possible.

The statement from Gottlieb comes less than a week after officials with the FDA requested that Endo Pharmaceuticals remove its opioid pain medication, oxymorphone hydrochloride (reformulated Opana ER), from the market, noting that "after careful consideration, the agency is seeking removal based on its concern that the benefits of the drug may no longer outweigh its risks."

The request was the first time the agency has taken steps to remove a currently marketed opioid pain medication from sale due to the public health consequences of abuse, according to a prepared statement from the FDA.

Reference

Gottlieb S. FDA is taking new steps to help assess opioid drugs with abuse-deterrent properties [FDA statement]. June 13, 2017. Accessed at:

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https://www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/ucm562961.htm