FDA considers new pill form of powerful opioid, despite warnings and history of unintended consequences

Posted at 8:48 AM, Oct 23, 2018
and last updated 2018-10-24 13:28:23-04

(RNN) – The FDA is considering whether to approve a new pill form of a powerful opioid that the chairman of an advisory committee that voted to approve it has called a “danger to the general public health.”

The FDA will decide by Nov. 3 whether to allow pharmaceutical company AcelRx to begin producing Dsuvia, a new sublingual (taken under the tongue) form of sufentanil, an opioid that is considered more potent than fentanyl, one of the drugs central to the opioid crisis.

Sufentanil has historically been primarily administered intravenously (IV). The company has argued this new version, which is designed to be taken only under medical supervision from a single-dose applicator, is necessary as an “important non-invasive, rapidly acting alternative to IV opioids.”

An FDA advisory panel voted 10-3 for its approval earlier this month. A version called Dzuveo has already been approved by the European Commission.

But the chairman of the FDA panel, Dr. Raeford Brown, has forcefully and publicly dissented.

In a statement sent by the group Public Citizen last week to FDA administrators who will ultimately decide Dsuvia’s fate, Brown made the case that allowing production of the drug in a smaller, more portable tablet form will likely have unintended consequences.

Namely, Brown warned, it will be highly difficult to strictly ensure a proper and legal distribution of the drug, something the FDA has failed to do in previous instances with opioids.

“The agency feels that there is a capability, so far not demonstrated, to regulate this drug so that it is used only in closely controlled settings,” Brown wrote. “In order to have this happen, the education of all prescribers would need to be guaranteed. This has not been demonstrated with any other opioid and … there is currently no educational nor regulatory scheme that will guarantee that this drug will be used only as described in the label.”

Brown predicted “that we will encounter diversion, abuse, and death within the early months of its availability on the market.”

“Sublingual sufentanil represents a danger to the general public health and will make our job of protecting Americans more difficult,” he concluded.

Other doctors have insisted that the drug’s distribution can indeed be safely managed by professionals.

“Although we are in the midst of an opioid crisis, from my understanding, this will only be administered by professional healthcare providers in a hospital or similar setting,” Dr. Jeff Gudin, the director of pain management and palliative care at a New Jersey hospital, told MD Magazine.

He agreed with the vote to approve Dsuvia and said it could “fill an unmet need” in pain management treatments.

One doctor on the advisory panel who voted to approve it, Dr. Ronald Litman of Children’s Hospital of Philadelphia, told BuzzFeed News that “it may potentially be useful in the emergency room setting or for our soldiers on the battlefield” if they cannot get an IV.

And the chief medical officer of AcelRx, Pamela Palmer, argued that the relatively lower dose in this product would blunt its abuse.

“I don’t think other people would want it - it won’t deliver the effect that illicit drug users want in such a very low dose,” she told BuzzFeed.

But a 2017 regulatory summary review, which was included with a briefing document for the Oct. 12 meeting where the advisory panel approved the drug, said the FDA’s Controlled Substances Staff concluded “that the major risks associated with Dsuvia are opioid overdose and unauthorized access to the product for purposes of misuse and abuse.”

And the agency’s risk evaluation for the drug (officially a Risk Evaluation and Mitigation Strategy, or REMS) did not “specifically address the risks of abuse, misuse, and addiction because this product will be used exclusively in inpatient settings” even though the drug was tested in outpatient settings.

And a company press release from just a week ago quoted a University of Minnesota Medical Center professor, Dr. Jacob Hutchins, touting the drug’s benefits because “pain is the most common reason for delayed discharge from outpatient surgery centers and the main reason for unanticipated hospital admissions.”

The FDA also has a checkered history with controlling the spread of opioids once they’re on the market.

Those drugmakers then “failed to ban doctors with repeated violations from prescribing the drugs.”

“The lax enforcement had consequences: the majority of patients prescribed the potent subdrugs didn’t qualify and some of them died,” the investigation found. “The drugmakers prospered from sales of the high-priced drugs.”

Dr. Brown noted a “lack of historical ability of the FDA to enforce controls” as one reason he would “never consider this product for marketing in the U.S.”

Dsuvia, the Public Citizen letter warned, “will only add to the worsening, not the mitigation, of the opioid epidemic in this country.”

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