12/17/2017
`
`Press Announcements > FDA requests removal of Opana ER for risks related to abuse
`
`FDA News Release
`
`FDA requests removal of Opana ER for
`risks related to abuse
`
`For Immediate Release
`
`June 8, 2017
`
`Release
`
`Español (/NewsEvents/Newsroom/ComunicadosdePrensa/ucm562499.htm)
`
`Today, the U.S. Food and Drug Administration requested that Endo Pharmaceuticals remove its opioid pain
`medication, reformulated Opana ER (oxymorphone hydrochloride), from the market. After careful consideration, the
`agency is seeking removal based on its concern that the benefits of the drug may no longer outweigh its risks. This
`is the first time the agency has taken steps to remove a currently marketed opioid pain medication from sale due to
`the public health consequences of abuse.
`
`“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,” said FDA Commissioner Scott Gottlieb, M.D. “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.”
`
`The FDA’s decision is based on a review of all available postmarketing data, which demonstrated a significant shift
`in the route of abuse of Opana ER from nasal to injection following the product’s reformulation. Injection abuse of
`reformulated Opana ER has been associated with a serious outbreak of HIV and hepatitis C, as well as cases of a
`serious blood disorder (thrombotic microangiopathy). This decision follows a March 2017 FDA advisory committee
`meeting where a group of independent experts voted 18-8 that the benefits of reformulated Opana ER no longer
`outweigh its risks.
`
`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. In 2012, Endo replaced the original formulation
`of Opana ER with a new formulation intended to make the drug resistant to physical and chemical manipulation for
`abuse by snorting or injecting. While the product met the regulatory standards for approval, the FDA determined
`that the data did not show that the reformulation could be expected to meaningfully reduce abuse and declined the
`company’s request to include labeling describing potentially abuse-deterrent properties for Opana ER. Now, with
`more information about the risks of the reformulated product, the agency is taking steps to remove the reformulated
`Opana ER from the market.
`
`https://www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/ucm562401.htm
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`1/3
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`Purdue - IPR2018-00625; IPR2018-00717, Ex. 2024
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`12/17/2017
`
`Press Announcements > FDA requests removal of Opana ER for risks related to abuse
`
`“The abuse and manipulation of reformulated Opana ER by injection has resulted in a serious disease outbreak.
`When we determined that the product had dangerous 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. “This action will protect the public from further potential for misuse and abuse of this product.”
`
`The FDA has requested that the company voluntarily remove reformulated Opana ER from the market. Should the
`company choose not to remove the product, the agency intends to take steps to formally require its removal by
`withdrawing approval. In the interim, the FDA is making health care professionals and others aware of the
`particularly serious risks associated with the abuse of this product.
`
`The FDA will continue to examine the risk-benefit profile of all approved opioid analgesic products and take further
`actions as appropriate as a part of our response to this public health crisis.
`
`The FDA, an agency within the U.S. Department of Health and Human Services, promotes and protects the public
`health by, among other things, assuring the safety, effectiveness, and security of human and veterinary drugs,
`vaccines and other biological products for human use, and medical devices. The agency also is responsible for the
`safety and security of our nation’s food supply, cosmetics, dietary supplements, products that give off electronic
`radiation, and for regulating tobacco products.
`
`###
`
`Inquiries
`
`Media
`
`  Sarah Peddicord (mailto:sarah.peddicord@fda.hhs.gov)
`  301-796-2805
`
`  Michael Felberbaum (mailto:michael.felberbaum@fda.hhs.gov)
`  240-402-9548
`
`Consumers
`
`  888-INFO-FDA
`
`Related Information
`
`FDA: March 13-14, 2017 Meeting of the Anesthetic and Analgesic Drug Products Advisory Committee
`(/AdvisoryCommittees/CommitteesMeetingMaterials/Drugs/AnestheticAndAnalgesicDrugProductsAdvisoryCommittee/uc
`FDA: Opioid Medications (/Drugs/DrugSafety/InformationbyDrugClass/ucm337066.htm)
`FDA: How does FDA decide when a drug is not safe enough to stay on the market?
`(/AboutFDA/Transparency/Basics/ucm194984.htm)
`FDA: Drug-Specific Information, Opana ER
`(/Drugs/DrugSafety/PostmarketDrugSafetyInformationforPatientsandProviders/ucm562339.htm)
`
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`12/17/2017
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`Press Announcements > FDA requests removal of Opana ER for risks related to abuse
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