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Opioid Rotation From Opana ER Following FDA Call for Removal

Switching from one opioid to another is never easy, but when the FDA pulls a product from the market, the urgency to find a replacement may make the process that much more difficult. A review of what products may be an appropriate substitute for Opana ER and why is provided.
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The US Food and Drug Administration (FDA) asked Endo Pharmaceuticals to voluntarily remove Opana ER from the market in June 2017.1 A month later, Endo announced their compliance with the request to remove the product. Shipments of Opana ER will end on September 1, 2017 to enable patients to convert to an appropriate alternative treatment, noted the company.

As experienced pain clinicians, we are concerned with the potential ramifications that may follow the removal of any opioid product from the marketplace, particularly one used in the treatment of thousands of patients suffering with chronic pain. This removal threatens to, at least temporarily, disrupt treatment, worsening patient discomfort (or far worse) and leaving many clinicians scrambling to figure out what to do next.

We do not wish to debate the merits (or lack thereof) of the FDA’s decision. However, we also recognize that the thousands of patients who had been prescribed Opana ER each month and the thousands of clinicians doing the prescribing may view this as a potential emergency. Opana ER is formulated with abuse-deterrent technology. Although Opana ER was never approved by the FDA as an abuse-deterrent formulation (ADF), if someone attempts to crush and dissolve the tablets, they turn into a gel that is difficult to inject.2 Crushing Opana ER into a fine powder for snorting also is difficult.2 Prescribers will need to make an educated and safe rotation to an alternative opioid based on the best therapeutic decisions and clinical evidence available. Patients treated with the branded Opana ER are matched by thousands taking generic oxymorphone ER, which has no abuse-deterrent properties, is more easily abused, and has not been affected by the FDA request.

Knowing how to accomplish an opioid rotation safely is an important, but often atrophied, skill in the prescriber community. It has become increasingly important, with clinicians now encouraged to stay within sanctioned morphine milligram equivalent (MME) limits set forth in various guidelines (and in certain circumstances, in state laws). The ability to switch nimbly, but safely, between opioids may even capitalize on incomplete cross-tolerance and might be a way to maintain response and decrease total daily doses, even to within acceptable limits.

In the earlier days of expanded opioid prescribing, the fact that there was no pharmacologic ceiling was taken to mean that prescribing high doses reached slowly and methodically over time was a legitimate way to dose opioids. One consequence might have been that clinicians did not learn all they needed to about rotating these drugs. Now that the mores of practices, or at least the approach to prescribing, have changed, it has become particularly crucial to revisit the critical concepts behind opioid rotation.

One final point to remember before we delve into the thought process of deciding which drug to target and the challenges of switching medications is that this can and should be done slowly and carefully. Just because the mathematics of a switch seems straightforward does not mean it will be a smooth and easy transition for patients, especially those who had been treated with Opana ER for a long time.3,4 As we used to tell patients, “Your liver and kidneys don’t know how to add.”

Clinicians should be prepared to change practice patterns to get this done right. It will likely require the patient following up weekly, not monthly. Opioid rotation has its origins in cancer pain management, which means it was often done in semi-emergent situations. For example, a patient with new disease progression has a dramatic increase in pain and has their opioid dose rapidly escalated. In the process, they develop delirium and need to be rotated to a new drug; this often was done all at once, generally in an institutional setting.5 In outpatient practice, this should be done more slowly and methodically to avoid catastrophic, idiosyncratic reactions.

Targeting a Medication to Try in Lieu of Opana

Marketing Initiatives Likely

Fortunately, there are numerous available options for clinicians to consider, with several branded, proprietary products available, as well as generic alternatives that may be effective (Table 1). Moreover, it is a certainty that other pharmaceutical companies are preparing to capitalize on the withdrawal of Opana ER as an opportunity to invite switches to their product. In so doing, they will offer reasons for clinicians to consider their product. Considering the idiosyncrasies of various opioids and variable response, no one product will suffice.

Our experience tells us that most companies are ethical. More to the point, they will likely be practical enough to recognize that their extended-release opioid (ERO) will not be the right product for 100% of the patients who had been taking Opana ER. Although companies would love to see patients switched to their respective product, they are likely to recognize that for some prescribers, the switch away from Opana ER might represent the first real opportunity for their drug to be considered as an appropriate ERO replacement.

We believe any respectable company would like to avoid the “one-trial learning” that accompanies a treatment failure, or worse, on the first occasion a prescriber uses their product. Thus, we believe that they too would like to see only those patients who have the highest likelihood of a reasonable tolerability and response switched to their product.  

To begin the process, it might be helpful for clinicians to remind themselves why the patient was receiving Opana ER in the first place. For many years, Opana ER was the second-most commonly prescribed branded long-acting opioid, per market analyses.6 Many patients started on Opana ER after trying another long-acting opioid (perhaps generic long-acting products such as morphine ER or fentanyl patches with or without the most commonly prescribed branded long-acting opioid, OxyContin). Given that Opana ER had 1 of the highest levels of persistence of therapy over all the long-acting opioid products, clinicians might need to review the medical record to be reminded of how the patient initially came to be on Opana ER.6

Last updated on: August 16, 2017
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