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Caroline Hroncich was associate editor for Pharmaceutical Technology, Pharmaceutical Technology Europe, and BioPharm International from 2015 to 2017.
FDA asked Endo Pharmaceuticals to remove Opana ER from the market, citing the potential for abuse.
In an unprecedented statement, FDA asked Endo Pharmaceuticals to remove its opioid Opana ER (oxymorphone hydrochloride) from the market. In a June 8, 2017 press release, the agency said it was requesting Endo “voluntarily remove” Opana ER from the market based on postmarketing data that indicated a “significant shift in the route of abuse” after the drug was reformulated. This is the first time the agency has requested a company remove an opioid from the market.
Endo reformulated Opana ER in 2012 with the intention of making it resistant to the physical and chemical manipulation consistent with abuse. However, the agency said that data on the reformulated version of the drug did not appear to “meaningfully reduce abuse.” In addition, FDA said it has found that injection abuse of the reformulated Opana ER is associated with an outbreak of HIV and hepatitis C, as well as the blood disorder thrombotic microangiopathy.
In a March 2017 advisory meeting, the agency voted 18–8 that the benefits associated with Opana ER no longer outweigh the risks. If Endo does not take steps to remove Opana ER from the market, the agency said it intends to move to withdrawal its approval.
Endo responded in a statement saying that it was reviewing FDA’s request. “Despite the FDA's request to withdraw Opana ER from the market, this request does not indicate uncertainty with the product's safety or efficacy when taken as prescribed. Endo remains confident in the body of evidence established through clinical research demonstrating that Opana ER has a favorable risk-benefit profile when used as intended in appropriate patients,” the company wrote. Seeking Alpha reported the company’s shares fell 14% after FDA released its request.
Newly appointed FDA Commissioner Scott Gottlieb, MD, outlined his intention to combat opioid abuse in an FDA Voice Blog in May 2017. Gottlieb said he intends to create a steering committee to review the agency’s response to opioid abuse in the United States.
“We are facing an opioid epidemic–a public health crisis, and we must take all necessary steps to reduce the scope of opioid misuse and abuse,” Gottlieb said in a statement. “We will continue to take regulatory steps when we see situations where an opioid product’s risks outweigh its benefits, not only for its intended patient population but also in regard to its potential for misuse and abuse.”