The Controversial Approval of Dsuvia by the FDA

Nov 21, 2018 8:23:13 AM by Mario Ramirez, MD

DsuviaEarlier this month on November 2nd, the U.S. Food and Drug Administration approved Dsuvia, a new sublingual version of an older drug, sufentanil, that has been in use since 1984. 

 While most drug approval events do not receive much spotlight, the nation’s worsening opioid epidemic focused greater attention on Dsuvia’s approval and forced many to ask whether approval of a new opioid is truly something that’s needed at this time.  We’re breaking down the issue for our readers, so they can better understand the controversy that’s been generated and help them make an informed decision about its use.

What is Dsuvia?

Dsuvia is a sublingual form of sufentanil, a more potent form of fentanyl that has been in clinical use since the early 1980s.  Primarily used for intravenous and epidural purposes in hospital settings, sufentanil, along with fentanyl also happens to be the one of the two most frequently diverted opioids.[1]  Dsuvia was developed by drug maker AcelRx and is supplied in single use applicators with a 30 mcg dose that according FDA Administrator Scott Gottlieb, “is delivered in a stable form that makes it ideally suited for certain special circumstances where patients may not be able to swallow oral medication, and where access to intravenous pain relief is not possible.”[2]  The product was reportedly developed with financial support from the U.S. Department of Defense who wanted to offer a field-stable pain management option for injured troops without viable drug administration access.  The time to deliver clinically significant pain relief is approximately one-hour according to clinical studies.

Why is there a Dsuvia Controversy?

In his statement on Dsuvia’s approval, Director Gottlieb made the point that whenever the FDA considers a drug for approval, it considers each drug on its individual merit.  Acknowledging the worsening opioid epidemic, however, he also went on to note that Congress’ recent intent with the opioid bill was to grant FDA greater authority around opioid regulation to address supply and control concerns around these drugs, and said they were a “unique class of medicines,” that require particular oversight.2  As a result, each new approval in this area should fill a particular or unique niche that isn’t currently filled by formulations or drugs already on the market.

In a very public rebuttal, Dr. Raeford Brown, a Professor of Anesthesiology and Pediatrics at the University of Kentucky, and Chair of the Food and Drug Administration’s Advisory Committee (ACAADP) on Anesthetic and Analgesic Drug Products, along with Sidney Wolfe, founder and Senior Advisor at Public Citizen’s Health Research Group, co-wrote an op-ed in The Washington Post, which argued not only that Dsuvia fails to fill unmet analgesic needs, but that it also represents a critical risk for diversion and misuse.1  Their arguments were several but notably include:

  • A flawed clinical trials process in which the drug was tested after “minor surgical procedures,” but not in patients with massive trauma or shock such as would be encountered on the battlefield
  • A time of onset of one hour that is considerably longer than preferable in these types of patients for whom intravenous or other access could be secured more quickly
  • An allegation that members of the FDA’s drug safety advisory commission were disinvited from an October 12th advisory committee meeting that made a favorable vote for approval more likely.

The went on to argue that in light of those points above along with its field stability, that the drug would “add to the flood of opioids that are feeding the epidemic1” and lead to more unnecessary overdose deaths.

The op-ed was controversial for a number of reasons not the least of which included an argument that the approval process had been unfairly tainted and no longer served the public interest.  Compounded by the fact that it was co-written by Dr. Brown, the Chair of the ACAADP, lent particular credibility and weight to the criticism.

In Response and Where Dsuvia Stands Now

For its part, the FDA has reportedly implemented a Risk Evaluation and Mitigation Strategy (REMS) to accompany the drug and argues that it “will tightly control its distribution and use.2” Director Gottlieb noted that distribution will be limited to specially certified health care settings and that continual implementation monitoring of the REMS will be used to make regulatory adjustments as needed.  In his approval statement, he also noted that he will be directing FDA staff to clearly delineate a new framework for opioid analgesic approvals that will be forthcoming at a future date.  This framework would be designed to address the public health concerns inherent around opioids, but also clear enough to provide a framework for drug developers and manufacturers who are interested in understanding where unmet needs exist.

Its unlikely that Dsuvia will be the last controversial opioid to seek FDA approval and it will be interesting to see how the approval process changes in light of these recent events.  In the meantime, you can turn to our blog for updates on Dsuvia as well the opioid approval process.  We’ll gather the facts to help you make an informed decision for yourself.

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References

[1] https://www.washingtonpost.com/opinions/the-fda-made-the-wrong-call-on-this-powerful-new-opioid/2018/11/16/39b212e2-e464-11e8-ab2c-b31dcd53ca6b_story.html?utm_term=.2166f06eda3b

[2] https://www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/ucm624968.htm

Topics: dsuvia, FDA, Raeford Brown, Opioid Therapy, Opioid Epidemic

 

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