FDA requests to remove Endo's opioid pain medication from the market

Kristen Gonzales
June 9, 2017

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".

Opana ER was first approved in 2006 for the management of moderate-to-severe pain when a continuous, around-the-clock opioid analgesic is needed for an extended period of time. The pill became notorious after it was blamed for prompting an HIV outbreak in rural in in 2015, and it was also linked to reports of a rare but serious blood disease characterized by clots that can lead to organ damage.

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. As opioid abuse continues to take a heavy toll on communities in IN and across the country, we must take steps to confront this public health epidemic.

As public health authorities and the FDA became increasingly concerned about the nation's epidemic of opioid abuse and overdoses, the company reformulated the drug in 2012, by adding a coating that was meant to make it harder to snort or inject the medicine.

Endo, which has its USA headquarters in Malvern, said it was reviewing the request and "evaluating the full range of potential options". The company defended its drug, a version of the medicine oxymorphone hydrochloride, citing the opioid's effectiveness in alleviating pain and Endo's efforts to prevent abuse.

This is the first time that the federal agency has requested that a drug company voluntarily stop selling a medication because of the risk of abuse that the drug carries, the FDA said in a statement.

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Drug overdose deaths have been on the rise in the U.S., with opioid overdoses accounting for more than 33,000 deaths in 2015, according to the U.S. Centers for Disease Control and Prevention.

Abuse of the drug via.

The request was made after the FDA determined that injecting the drug, which is one way of abusing it, was linked to outbreaks of disease, including HIV and hepatitis C. Other states and cities have filed similar lawsuits. "This action will protect the public from further potential for misuse and abuse of this product". "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, attempting to fight drug abuse, claimed to have reformulated the drug so that it could not be crushed or molded for snorting or injection.

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

Other reports by TheSundaySentinel

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