June 9, 2017
By Alex Keown, BioSpace.com Breaking News Staff
WASHINGTON – As the nation continues to grapple with an opioid addiction crisis, the U.S. Food and Drug Administration has made a bold move, it has asked Endo Pharmaceuticals to remove its opioid pain medication, reformulated Opana ER, from the market.
On Thursday, FDA Commissioner Scott Gottlieb said the nation is facing an opioid epidemic, which is forcing the agency to take the “necessary steps to reduce the scope of opioid misuse and abuse.” The announcement follows the thoughts of an FDA advisory committee which suggested earlier this year that Opana ER should be pulled from the shelves. The FDA’s request is the first time the agency has taken steps to remove a current opioid product due to concerns over abuse.
“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,” Gottlieb said in a statement.
The FDA’s request caused shares of Endo to fall in premarket trading. Shares are down more than 12 percent this morning, trading at $12.17, below Thursday’s closing price of $13.78.
Ireland-based Endo said Thursday it was reviewing the FDA’s request and is evaluating potential options as the company determines the “appropriate path forward.” In a statement issued Thursday, the company said the benefits for opioid-based pain treatments are widely recognized, but as the drugs have become more prevalent, so too have the levels of abuse in the United States.
“As a pharmaceutical company with a demonstrated commitment to the improvement of pain management, Endo feels a strong sense of responsibility to improve the care of pain for patients while at the same time taking comprehensive steps to minimize the potential misuse of its products,” Endo said in a statement.The FDA’s request is for Endo to voluntarily remove the product from the market. If Endo does not comply, the FDA said it will “take steps to formally require its removal by withdrawing approval.”
Opana ER was initially 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. Six years later the company changed the formulation of Opana ER in order to make it more resistant to physical and chemical manipulation from those hoping to abuse the drug. The FDA said the reformulation of the drug met its standards, the data did not show the new formula could be expected to “meaningfully reduce abuse” of those who wanted to snort or inject the drug. As a result, the FDA rejected Endo’s request to include labeling describing potentially abuse-deterrent properties for Opana ER.
Janet Woodcock, director of the FDA’s Center for Drug Evaluation and Research, said in a statement that the “abuse and manipulation” of reformulated Opana ER “has resulted in a serious disease outbreak.”
Not only has Opana ER been abused for the opioid high, but in 2015 the drug was linked to an outbreak of HIV in rural Indiana due to opioid abusers sharing needles, NPR reported. According to that report, it was only after the drug was reformulated that people began to inject the drug because it was no longer easy to crush and snort it.
Opioid addiction has reached epidemic proportions in the United States. According to the U.S. Department of Health and Human Services, 78 Americans die daily from opioid overdoses. During his confirmation earlier this year, Gottlieb expressed concern over the growing opioid epidemic. In March, President Donald Trump formed a commission tasked with fighting the growing opioid epidemic.
Several companies have been at the center of public concerns of opioid-based drugs, including Purdue Pharmaceuticals the maker of OxyContin--a drug that has become one of the most abused pain treatments in the United States. Arizona-based Insys has also seen its share of problems over allegations of corrupt marketing practices to push Subsys, the company’s fentanyl-based pain medication.
