US FDA asks Endo to withdraw Opana ER opioid; shares fall

Opana ER was approved by the FDA for pain management in 2006 as an extended-release opioid.

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 March, an FDA advisory committee voted 18-8 that the benefits of the reformulated Opana ER no longer outweighed the risks it posed.

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".

The drug was reformulated in 2012 in an attempt to make the medication more hard for people to abuse; specifically, the drug makers sought to make it hard for users to snort or inject the drug.

Endo's stock was down more than 14% after-hours on Thursday.

Endo, which has its US headquarters in Malvern, said it was reviewing the request and "evaluating the full range of potential options".

FDA officials said their decision is based on a review of all available postmarketing data, which demonstrated a significant shift in the route of abuse of the reformulated product from nasal to injection following the product's reformulation.




Today's announcement said that even though Opana ER was reformulated to reduce its potential abuse, that reformulation had not meaningfully made a difference.

Endo has had other issues with the FDA and the drug.

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

Endo had touted the new formulation as abuse-resistant, though the FDA did not allow the company to market it as such when granting approval for sales several years ago. The company said when taken as prescribed Opana ER has a favorable risk-benefit profile. "When we determined that the product had risky unintended consequences, we made a decision to request its withdrawal from the market".

The FDA has previously requested that companies remove opioid painkillers from the market; however, in those cases it was not because of the risk of abuse that the drug carried. "This action will protect the public from the further potential for misuse and abuse of this product".

"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. However, the company came under fire from both the FDA and the state of NY for not making significant changes that reduced the risk of abuse.

Endo had about $4 billion in revenue previous year, only $159 million of that from Opana.

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