On Tuesday, FDA Commissioner Scott Gottlieb, MD, announced the agency would hold a public meeting on July 10-11 to examine opioid medications with abuse-deterrent properties. The action comes hard on the heels of a request late last week from FDA that Endo Pharmaceuticals voluntarily remove its Opana ER (oxymorphone hydrochloride) drug from the market because of the growing incidents of manipulation and misuse.
FDA aims to gather information to determine whether products with abuse-deterring formulations are having the intended impact.
“We recognize that there is a gap in our understanding of whether these products result in a real-world, meaningful decrease in the frequency and patterns of opioid misuse and abuse,” he said in a statement.
Unprecedented market move
In March, an FDA advisory committee voted 18-to-8, deciding that the benefits of the abuse-deterrent formulation of Opana ER no longer outweigh its risks. Individuals are still able to crush the tablets and inject the substance.
“Reformulated Opana ER, along with its generic counterpart, had the highest injection abuse rates following reformulation,” said Megan Polanin, PhD, National Center for Health Research, in her testimony to the advisory committee in March.
She also said “abuse-deterrent” is not an accurate term for the drug because it is widely abused.
The agency’s follow-up request to pull the powerful extended-release opioid product from the market is unprecedented.
According to FDA, should Endo Pharmaceuticals choose to continue sales of Opana ER, the agency would take steps to force its removal from the market by withdrawing approval. According to a statement, Endo is reviewing the FDA request, but it has not agreed to withdraw the product.