Voluntary Removal of Opioid Opana ER from the Market

Posted by Stephanie Labonville on Aug 2, 2017 8:00:00 AM

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Endo Pharmaceuticals Inc. recently released news that it will voluntarily remove Opana ER from the market, with planned shipments slated to end September 1, 2017.  This news follows the Food and Drug Administration’s (FDA) June 2017 request to withdraw Opana ER from the market due to risks related to abuse. 

While this product is being discontinued from Endo Pharmaceutical’s product line, the available Opana ER that is available on the market may still continue to be used as this medication has not been recalled.  In fact, according to a company spokeswoman, shipments will continue through September 1 to "enable time for patients currently taking Opana ER to work with their physicians to convert to an appropriate alternative treatment."

Opana ER is a long-acting (extended-release) opioid prescription pain medicine that is used to manage pain severe enough to require daily, around-the-clock, long-term opioid treatment. This medication was first approved in 2006 and in 2012, Endo replaced the original formulation with a new formulation intended to make the drug resistant to physical and chemical manipulation for abuse by snorting or injecting.  Now, with more information about the risks of the reformulated product, the FDA has requested its removal from the market – to which Endo Pharmaceuticals has obliged.

Why is Opana ER being voluntarily removed from the market?

The FDA’s decision to request the removal of Opana ER from the market is based on an extensive review of post-marketing data, which showed that following the product’s reformulation, there was a significant shift in the route of abuse from nasal to injection. Injection abuse of the reformulated medication has been associated with a serious outbreak of hepatitis C and HIV, 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.

What should anyone taking Opana ER do now?

Endo Pharmaceuticals suggests, “[p]atients taking OPANA® ER should discuss treatment options with their prescribing physician at their next visit.”  While there are other long acting products available, transitioning off of Opana ER does not automatically mean someone should just move to another long acting opioid.  The discussion of what to do about the removal of this opioid from the market for people that are taking the medication should start with a conversation about what that individual’s best plan going forward will be. Taking a look at the individual’s treatment goals and revisiting some things to think about before continuing opioids can be helpful before going forward. For instance, is an opioid medication going to offer more benefit than risk at this time? What other alternatives might be an option?

What else is the FDA working on in relation to opioids?

The request for removal of Opana ER is likely not the last we’ll hear from the FDA on their efforts to respond to the current opioid crisis, while balancing the need for people in pain to have access to effective pain relief.

The FDA has been working on its’ timeline of addressing opioid misuse and abuse and has established a far-reaching action plan, which includes plans to expand the use of advisory committees, develop warnings and safety information for immediate-release (IR) opioid labeling, strengthen post-market requirements, update Risk Evaluation and Mitigation Strategy (REMS) Program, expand access to abuse-deterrent formulations (ADFs) to discourage abuse, support better treatment, and reassess the risk-benefit approval framework for opioid use.

The FDA has also commissioned a study from the National Academies of Sciences, Engineering, and Medicine (NASEM). NASEM has been asked to identify additional actions the FDA should consider to address the opioid crisis, with a particular focus on approaches the agency can take to support a more formal assessment of public health risks and benefits within its benefit-risk framework for opioids.

Further, on July 10-11th, 2017 the FDA held a Scientific Meeting on Opioids where FDA Commissioner, Dr. Gottlieb, outlined some further steps the FDA intends to take in regards to opioids including, stating the FDA intends to update the existing REMS on extended release opioid analgesics, and for the first time, extend these same regulatory requirements to the manufacturers of immediate release opioid analgesic products. 

The FDA isn’t the only one looking at optimizing pain care while dealing with the opioid epidemic in the United States.  Among several other initiatives, The National Institutes of Health has announced they will take a scientific “all hands on deck” approach in their new push to fight the opioid crisis, with fresh efforts to develop better drugs to fight addiction, treat pain, and stop overdoses. 

The voluntary removal of Opana ER from the market joins the flurry of news surrounding opioids and the many future plans for balancing effective pain care with the opioid epidemic in the United States.

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Topics: Clinical