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Introduction

Opana ER is the brand name for oxymorphone hydrochloride extended-release tablets, a potent opioid analgesic that was approved by the FDA in 2006 for the management of pain severe enough to require daily, around-the-clock, long-term opioid treatment . For a period, it was prescribed for patients with chronic severe pain who had not responded adequately to other treatments.

Opana ER's story, however, is not primarily a story about analgesia. It is a story about formulation changes, shifting patterns of abuse, and a public health crisis that ultimately led the FDA to request the product's removal from the market—the first time the agency had taken such an action for an opioid due to abuse-related harms . In December 2020, the FDA formally withdrew approval of the reformulated Opana ER application, and distribution of the product in interstate commerce without an approved application is illegal .

This guide covers Opana ER in full: what it was, its clinical profile, its regulatory history, the reasons for its withdrawal, and the broader lessons its trajectory illustrates.

What Is Opana ER?

Opana ER was an extended-release formulation of oxymorphone hydrochloride, a mu-opioid agonist and a Schedule II controlled substance with an abuse liability similar to other opioid analgesics .

Available Formulations (Historical)

Opana ER was manufactured in seven strengths: 5 mg, 7.5 mg, 10 mg, 15 mg, 20 mg, 30 mg, and 40 mg extended-release tablets . The tablets were designed to be swallowed whole and were not to be broken, chewed, crushed, or dissolved, because doing so could lead to the rapid release and absorption of a potentially fatal dose of oxymorphone .

Two Formulations: Original and Reformulated

Opana ER existed in two distinct formulations over its commercial life:

Original formulation (approved 2006): A conventional extended-release tablet. The primary route of abuse for this formulation was nasal insufflation (snorting) after crushing the tablet into powder .

Reformulated formulation (approved 2011/2012): An abuse-deterrent formulation (ADF) designed to make the tablet harder to crush and insufflate. The manufacturer removed the original formulation from the market over the course of 2011 and 2012 and replaced it with the ADF version .

Regulatory Status: Withdrawn

The reformulated Opana ER was approved under NDA 201655. On June 8, 2017, the FDA requested that Endo Pharmaceuticals remove the reformulated product from the market. Endo requested withdrawal of the application on October 3, 2017, and the FDA formally withdrew approval effective December 23, 2020 . The product is listed as Discontinued in the FDA's Orange Book .

The Clinical Profile (Historical)

Although Opana ER is no longer marketed, understanding its clinical profile is relevant to understanding why it was regulated as it was and why its withdrawal mattered to patients who had been prescribed it.

Approved Indication

Opana ER was indicated for the management of pain severe enough to require daily, around-the-clock, long-term opioid treatment and for which alternative treatment options were inadequate . It was not intended for use as an as-needed analgesic .

Mechanism of Action

Oxymorphone, like other mu-opioid agonists, produces analgesia by binding to opioid receptors in the central nervous system. Respiratory depression is the chief hazard of the medication, and it was the subject of a boxed warning .

Common Adverse Reactions

Adverse reactions reported in ≥2% of patients in placebo-controlled trials included: nausea, constipation, dizziness, somnolence, vomiting, pruritus, headache, sweating increased, dry mouth, sedation, diarrhea, insomnia, fatigue, appetite decreased, and abdominal pain .

Boxed Warnings and Serious Risks

Opana ER's prescribing information carried multiple boxed warnings, reflecting the serious risks inherent to potent extended-release opioids.

Addiction, Abuse, and Misuse

Opana ER exposed users to risks of addiction, abuse, and misuse, which could lead to overdose and death. As a modified-release product delivering opioid over an extended period, there was a greater risk for overdose and death due to the larger amount of oxymorphone present .

Life-Threatening Respiratory Depression

Serious, life-threatening, or fatal respiratory depression could occur with use of Opana ER, especially during initiation or following a dose increase .

Accidental Ingestion

Accidental ingestion of even one dose of Opana ER, especially by children, could result in respiratory depression and death due to an overdose of oxymorphone .

Interaction With Alcohol

Co-ingestion of alcohol with Opana ER could result in increased plasma levels and a potentially fatal overdose of oxymorphone. Patients were instructed not to consume alcoholic beverages or any prescription or non-prescription medications containing alcohol while on Opana ER therapy .

Risks From Concomitant Use With Benzodiazepines and Other CNS Depressants

Profound sedation, respiratory depression, coma, and death could result from combined use with benzodiazepines or other CNS depressants. Observational studies demonstrated that concomitant use of opioid analgesics and benzodiazepines increases the risk of drug-related mortality compared to use of opioid analgesics alone .

Neonatal Opioid Withdrawal Syndrome

Prolonged use of Opana ER during pregnancy could result in withdrawal in the neonate, which may be life-threatening if not recognized and treated .

The Abuse-Deterrent Formulation: Promise and Unintended Consequences

The reformulated Opana ER was intended to resist physical and chemical manipulation for abuse by snorting or injecting. Clinical studies showed that the ADF did reduce drug liking via nasal insufflation compared to oxymorphone powder . However, the real-world outcome was more complicated.

A Shift in Route of Abuse

Based on postmarketing data, the FDA observed that there was a significant shift in the route of abuse from nasal to injection following the product's reformulation . Although the crush-resistant formulation reduced the potential for intranasal inhalation, drug users identified methods for defeating the product's gelling properties and extracted oxymorphone for intravenous injection .

Public Health Consequences

Injection abuse of reformulated Opana ER was associated with a serious outbreak of HIV and hepatitis C, as well as cases of a serious blood disorder (thrombotic microangiopathy) . This association with blood-borne infections was a central factor in the FDA's determination that the benefits of the drug no longer outweighed its risks.

Research Findings on ADF Effectiveness

A study published in the journal Pain compared the effectiveness of abuse-deterrent formulations of OxyContin and Opana ER. While the OxyContin ADF was highly effective in reducing nonoral abuse (91.4% before the ADF, 47.9% afterwards), the Opana ER ADF showed a reduction in insufflation (80% to 37.1%) but no significant decrease over time in overall nonoral abuse . The researchers concluded that an ADF's effectiveness may be drug-specific, even when the same proprietary technology is used .

The Withdrawal From Market

FDA Request (June 2017)

On June 8, 2017, the FDA requested that Endo remove reformulated Opana ER from the market based on its concern that the benefits of the drug may no longer outweigh its risks due to the public health consequences of abuse . This was the first time the FDA had asked the manufacturer of an opioid pain medication to take its product off the market because of its potential for abuse .

Manufacturer Request and FDA Withdrawal (2020)

On October 3, 2017, Endo requested withdrawal of NDA 201655 for reformulated Opana ER and waived its opportunity for a hearing. The FDA formally withdrew approval effective December 23, 2020 . The Federal Register notice states directly: "Distribution of reformulated OPANA ER into interstate commerce without an approved application is illegal and subject to regulatory action" .

What the Opana ER Case Illustrates

The Opana ER trajectory offers several lessons that remain relevant to discussions of opioid prescribing and regulation.

Abuse-Deterrent Formulations Are Not a Complete Solution

The reformulation successfully reduced one route of abuse (nasal insufflation) but was associated with an increase in another (injection), which carried its own severe public health consequences. The case demonstrated that ADF technology can have unpredictable real-world effects and that each formulation must be evaluated on its own merits .

Postmarketing Surveillance Matters

The shift in abuse route and the associated HIV and hepatitis C outbreak were identified through postmarketing data, not pre-approval trials. This underscores the importance of continued monitoring after a product reaches the market.

Regulatory Action Can Follow Real-World Evidence

The FDA's request for withdrawal, and the eventual formal withdrawal of approval, illustrate that regulatory decisions can be revisited when real-world evidence indicates that a product's risks have shifted or become clearer.

Patients Were Affected

The withdrawal of Opana ER meant that patients who had been prescribed it for chronic pain needed to transition to alternative treatments. This is a genuine clinical consequence of regulatory action, and it underscores the importance of individualized pain management planning.

Frequently Asked Questions

Is Opana ER still available in the United States?

No. The FDA withdrew approval of the reformulated Opana ER application effective December 23, 2020. The product is listed as discontinued in the FDA's Orange Book, and distribution without an approved application is illegal .

Why was Opana ER taken off the market?

The FDA requested removal in June 2017 due to public health concerns. Postmarketing data showed a significant shift in the route of abuse from nasal to injection following reformulation, and injection abuse was associated with an outbreak of HIV and hepatitis C, as well as a serious blood disorder .

What was Opana ER used for?

It was indicated for the management of pain severe enough to require daily, around-the-clock, long-term opioid treatment, when alternative treatment options were inadequate .

What is oxymorphone?

Oxymorphone is the active ingredient in Opana ER. It is a mu-opioid agonist and a Schedule II controlled substance .

Was Opana ER an abuse-deterrent formulation?

The reformulated version approved in 2011/2012 was designed to be resistant to crushing and snorting. However, it did not prevent injection abuse, and the FDA determined that its benefits no longer outweighed its risks .

What should patients who were prescribed Opana ER do?

Anyone who was prescribed Opana ER should have been transitioned to an alternative treatment by their prescriber. Opana ER is no longer legally available, and patients should not seek it from unregulated sources.

Conclusion

Opana ER was a potent extended-release opioid analgesic that was approved for severe chronic pain and later reformulated with abuse-deterrent properties. Its trajectory—from approval in 2006, through reformulation in 2011/2012, to an FDA request for removal in 2017 and formal withdrawal of approval in 2020—illustrates the complex interplay between opioid pharmacology, formulation technology, real-world abuse patterns, and regulatory decision-making.

The case is notable for several reasons: it was the first time the FDA asked for an opioid's removal due to abuse-related harms; it demonstrated that abuse-deterrent formulations can have unintended consequences; and it showed that postmarketing surveillance can reveal risks that pre-approval trials did not. For patients, the withdrawal meant the need to transition to alternative pain management approaches under medical supervision.