Key Takeaways
- Opana ER is no longer manufactured, as Endo Pharmaceuticals voluntarily withdrew the brand-name reformulated product following FDA’s request on June 8, 2017.
- The FDA sought removal because postmarketing data showed abuse shifted from nasal to injection routes despite the 2012 abuse-deterrent reformulation.
- Injection abuse was linked to outbreaks of HIV, hepatitis C, and documented cases of thrombotic microangiopathy.
- Distribution halted on September 1, 2017, with Endo collaborating with the FDA for an orderly removal minimizing treatment disruption.
- The withdrawal affected only brand-name Opana ER; generic oxymorphone remains available in the U.S. from manufacturers like Amneal Pharmaceuticals.
Do they still make Opana
No, Opana ER isn’t made anymore. Endo Pharmaceuticals voluntarily withdrew the reformulated brand-name product after the FDA’s June 8, 2017 request, halting distribution starting September 1, 2017. The FDA concluded the drug’s benefits no longer outweighed its risks, driven by postmarketing data showing abuse had shifted from nasal to injection routes despite the 2012 abuse-deterrent reformulation. That reformulation failed to prevent dissolution for injection, and injection abuse was linked to an HIV and hepatitis C outbreak plus cases of thrombotic microangiopathy.
If you’re seeking oxymorphone, you’ve still got options. The withdrawal only affected the brand-name reformulated Opana ER, not generic oxymorphone. You can still access generic extended-release and immediate-release oxymorphone formulations from manufacturers like Amneal Pharmaceuticals, which fill the clinical need.
Why was Opana ER taken off the market
Opana ER was taken off the market because postmarketing data revealed a dangerous shift in abuse patterns. The FDA requested Opana ER’s removal on June 8, 2017, the first time the agency pulled an opioid due to abuse-related public health risks.
The 2012 reformulation, designed to deter abuse, backfired. Instead of stopping misuse, it shifted abuse from nasal to injection routes because the abuse-deterrent features couldn’t prevent dissolution in liquid for injection. This injection abuse triggered a serious HIV and hepatitis C outbreak and cases of thrombotic microangiopathy, a dangerous blood disorder.
The FDA concluded that Opana ER’s benefits no longer outweighed its risks. The agency also found Endo’s evidence insufficient to prove the reformulation reduced abuse. Given these public health consequences, the FDA determined removal was necessary.
What happened in the 2017 FDA market withdrawal
The 2017 FDA market withdrawal saw Endo Pharmaceuticals voluntarily withdraw Opana ER from the market in less than a month after the FDA’s June 8, 2017 request. Even as it agreed to withdrawal, Endo maintained the drug was safe and effective when taken as prescribed. You should understand the timeline: Endo agreed to stop distributing Opana ER starting September 1, 2017, giving prescribers time to switch patients to alternatives. The withdrawal cost the company roughly $20 million, while Q1 2017 net sales had totaled $35.7 million. Endo collaborated with the FDA to coordinate an orderly removal, minimizing treatment disruption. This action was unprecedented. It was the first time the FDA requested an opioid’s removal due to abuse-related public health risks, specifically the injection abuse driving HIV, hepatitis C, and thrombotic microangiopathy cases.
How injection abuse of the reformulated drug led to the removal
Injection abuse of the reformulated drug led to its removal because the 2012 reformulation shifted the problem rather than solving it. couldn’t stop dissolution in liquid, so misuse migrated toward injection. That route change drove serious public health consequences:
- Bloodborne disease transmission: Injection abuse triggered an outbreak of HIV and hepatitis C among users sharing equipment.
- Thrombotic microangiopathy: Injecting the reformulated product caused this serious blood disorder in multiple documented cases.
- Elevated overdose risk: Because oxymorphone is roughly twice as potent as oxycodone, injection amplified the danger.
When postmarketing data confirmed this shift, the FDA concluded that the reformulation’s benefits no longer outweighed its risks, prompting the unprecedented request to remove the drug.
What the FDA advisory committee concluded
The FDA advisory committee concluded that the reformulated product’s benefits no longer justified its risks. The postmarketing data shaped a formal review that culminated in the agency’s decision. The evidence centered on the failed reformulation and its unintended consequences.
| Finding | Conclusion |
|---|---|
| 2012 abuse-deterrent reformulation | Failed to prevent dissolution for injection |
| Abuse route shift | Moved from nasal to injection post-reformulation |
| Injection-linked outcomes | HIV, hepatitis C outbreak, thrombotic microangiopathy |
| Benefit-risk balance | Risks outweighed benefits |
The features meant to deter abuse didn’t stop illicit injection, so the agency requested removal, concluding the drug posed a serious public health threat.
Is generic oxymorphone still available
Yes, generic oxymorphone remains available in the U.S. despite the 2017 Opana ER withdrawal. The FDA’s request targeted only Endo’s brand-name reformulated Opana ER, not the underlying oxymorphone molecule. Manufacturers like Amneal Pharmaceuticals continue supplying generic formulations to meet legitimate clinical needs for severe pain management.
You’ll find these key points relevant when prescribing or switching patients:
- Original formulation available: Impax Laboratories (now Amneal) sold a generic version of the original 2006 formulation after the FDA denied Endo’s 2012 blocking petition.
- Patent retained: Endo kept the patent for the original formulation, which stayed legally available via generics.
Generic oxymorphone ER fills the ongoing clinical requirement.
How Miami Outpatient Detox connects people to opioid detox and treatment
Miami Outpatient Detox connects you to evidence-based detox and treatment services designed for safe passages. When you’re shifting off oxymorphone ER or another opioid, you need medically supervised tapering to manage withdrawal safely. Miami Outpatient Detox assesses your dependence severity, then matches you with appropriate detox protocols and medication-assisted treatment options. You’ll receive individualized care that addresses both physical dependence and relapse risk, particularly important given the injection-related complications documented with reformulated Opana ER. If you’ve been misusing opioids, the program links you to counseling, monitoring, and long-term recovery resources. By coordinating your detox with ongoing treatment, Miami Outpatient Detox helps you avoid dangerous abrupt discontinuation and supports sustained, evidence-based recovery.
Get Help for Oxymorphone or Opioid Dependence in Miami
If oxymorphone or another opioid has led to dependence, withdrawal symptoms, or difficulty controlling use, professional support can help you move forward safely. Miami Outpatient Detox can help you explore opioid detox, alcohol detox, medical detox, outpatient detox, and ongoing addiction treatment based on your clinical needs. Verify your insurance to review potential coverage, or call +1 (786) 228-8884 to discuss available treatment options in Miami.
Frequently Asked Questions
How Potent Is Opana ER Compared to Oxycontin?
You’re looking at a drug that’s roughly twice as potent as OxyContin. Opana ER contains oxymorphone hydrochloride, and milligram for milligram, it delivers about double the potency of oxycodone-based OxyContin. That heightened potency matters clinically because it raises your overdose risk, especially if the drug’s misused via injection. When you’re switching patients between these opioids, you’ll need to account for this difference to avoid dangerous dosing errors and respiratory depression.
What Is Thrombotic Microangiopathy Caused by Injected Opana ER?
Thrombotic microangiopathy is a serious blood disorder you can develop when you inject reformulated Opana ER. It’s linked to the drug’s abuse-deterrent formulation, which doesn’t dissolve properly for injection. When you inject it, you risk microvascular clotting that damages your blood cells and organs. This complication, alongside HIV and hepatitis C outbreaks, drove the FDA’s 2017 decision that Opana ER’s risks outweighed its benefits, prompting its withdrawal.
How Much Did the Opana ER Withdrawal Cost Endo?
The Opana ER withdrawal cost Endo approximately $20 million. To put that in perspective, you should know the drug generated $35.7 million in net sales during Q1 2017 alone, so you’re looking at a withdrawal expense that’s well below a single quarter’s revenue. When Endo voluntarily pulled the product in 2017, you’ll find the company absorbed this cost while coordinating an orderly market removal to minimize patient treatment disruption.
Why Did the FTC Sue Endo and Impax in 2021?
The FTC sued Endo and Impax in 2021 because they’d entered a profit-sharing agreement that allegedly eliminated competition in the extended-release oxymorphone market. You should understand this deal spanned 11 years, starting January 1, 2018. The FTC contended it was anticompetitive, effectively preventing rivalry between the two companies over ER oxymorphone products. By sharing profits rather than competing, they’d unlawfully restrained the market, prompting the FTC’s legal action against both manufacturers.
Are Abuse-Deterrent Opioids Effective at Preventing Injection Misuse?
You shouldn’t rely on abuse-deterrent formulations to fully prevent injection misuse. Opana ER’s 2012 reformulation proved this: despite abuse-deterrent features, the drug still dissolved in liquid, letting users inject it. Misuse simply shifted from nasal to injection routes, triggering HIV and hepatitis C outbreaks plus thrombotic microangiopathy cases. So while these features can reduce certain abuse pathways, they don’t guarantee protection, and you’ll want to weigh their real-world limitations carefully.