FDA Asks Endo Pharmacueticals To Pull Opana ER Due To Potential For Abuse

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FDA Asks Endo Pharmacueticals To Pull Opana ER Due To Potential For Abuse

Last week the Food and Drug Administration (FDA) made a request to remove the drug Opana ER (which contains oxymorphone) from the U.S. market. This is the first time the agency has made a move to pull an opioid drug currently prescribed for pain due to its potential for abuse.

At this time, however, that request is completely voluntary. Endo Pharmaceuticals, the company that makes Opana released a statement saying that the company is “…reviewing the request and…evaluating the full range of potential options as we determine the appropriate path forward.”

In an official statement from the FDA, the food and drug commissioner said that the continuing opioid epidemic raging in the U.S. was one reason for the request.

Dr. Scott Gottlieb:

“We will continue to take regulatory steps when we see situations where an opioid product’s risks outweigh its benefits…”

The extended-release (ER) drug was approved by the FDA in 2006 for the around-the-clock treatment of moderate to severe pain. But ER pain medications have a greater potential for addiction and overdose than many of their counterparts. Thus, physicians have been urged to only prescribe Opana ER to those patients who do not respond well to other treatments.

opapa er | Just Believe Recovery PAFive years ago, the drug was reformulated to make the tablets abuse-deterrent, or more difficult to crush, snort, or inject. However, Endo could not prove that the reformulation would significantly reduce the potential for abuse, and therefore the FDA did not allow Endo to market the drug as abuse-deterrent.

In fact, since the drug’s reformulation, the FDA says that data has revealed a “significant shift in the route of abuse of Opana ER from nasal to injection.” If Endo Pharma opts to leave Opana ER on the market, the FDA plans to withdrawal its approval for the drug.

In the meantime, the FDA is actively informing health care practitioners of the severe risks associated with Opana abuse.

Endo also stated that indeed, the misuse of opioids has significantly increased, but that the agency’s request
“does not indicate uncertainty with the product’s safety or efficacy when taken as prescribed.” Also, the company points out that more than half the FDA advisory committee members preferred that Opana remains on the U.S. market but with new restrictions in place.

~ G. Nathalee Serrels, M.A., Psychology



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