FDA asks Endo to withdraw Opana ER opioid, shares fall

Kathleen Mckinney
June 9, 2017

The Food and Drug Administration requested Thursday that the drugmaker Endo Pharmaceuticals stop selling Opana ER - its extended-release version of Opana.

FDA requests Opana, a commonly abused opioid prescription drug, to be taken off the market.

The company must now choose between voluntarily taking Opana off the market or face an impending formal FDA drug approval withdrawal.

Gottlieb said the agency 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". "When we determined that the product had risky unintended consequences, we made a decision to request its withdrawal from the market", Janet Woodcock, MD, director of the FDA's Center for Drug Evaluation and Research said in the FDA's prepared statement. The agency says this the first time it has asked that an opioid pain medication be pulled due to "the public health consequences of abuse".

Thursday's announcement followed a March vote from an independent group of experts, brought together by the FDA, who voted 18-8 that the benefits of reformulation no longer outweighed the risks.

If Opana ER sounds familiar, it's because it was the drug of choice for many addicts at the center of an HIV outbreak in IN in 2015. In 2012, Endo replaced the original formulation of Opana ER with a new formulation meant to make the drug resistant to physical and chemical manipulation for abuse by snorting or injecting.

"When we determined that the product had unsafe unintended consequences, we made a decision to request its withdrawal from the market", said Janet Woodcock, M.D., director of the FDA's Center for Drug Evaluation and Research in a statement.


If Endo refuses to withdraw the product, the FDA could offer the company an opportunity for a hearing to make the case for why the product should not be removed.

TRENTON, N.J. (AP) - U.S. regulators want a narcotic painkiller involved in the opioid epidemic off the market amid data showing people continue to abuse it.

Cities and states have started suing makers of opioid drugs, saying that they've pushed their drugs on doctors and patients alike, helping drice addiction.

"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", FDA Commissioner Dr. Scott Gottlieb said in a statement. "When we determined that the product had risky unintended consequences, we made a decision to request its withdrawal from the market".

"The abuse and manipulation of reformulated Opana ER by injection has resulted in a serious disease outbreak", said Dr. Janet Woodcock, director of the FDA's Center for Drug Evaluation and Research.

Those generic products might also face action by the FDA, which said it is "assessing the latest available data on abuse patterns".

Randall Stanicky, an analyst at RBC Capital Markets, said Opana ER is a declining asset whose sales are expected to fall to US$97 million in 2019, down from an estimated US$134 million in 2017.

Other reports by TheDigitalNewspaper

Discuss This Article

FOLLOW OUR NEWSPAPER