FDA approves a powerful new opioid, rejecting criticism from advisers

Ebony Scott
November 7, 2018

Officials with the FDA have approved a new opioid, (Dsuvia, AcelRx Pharmaceuticals), sparking some controversy in the media that the opioid has potential for abuse. Sufentanil is between five and 10 times more potent than fentanyl and the tiny pill is only three millimeters across. And in doing so, the agency addressed wider regulatory thinking for endorsing such a medicine amid nationwide angst about overdoses and deaths attributed to opioids. In a statement, FDA Commissioner Scott Gottlieb, MD, sought to deflect criticism of the approval, saying that, "Looking beyond this particular drug approval, I believe that we should consider whether we should be doing more to evaluate each candidate opioid, not just as an independent review decision, but rather also to consider each novel opioid drug in the context of the overall therapeutic armamentarium that's available to patients and providers". "It is certain that Dsuvia will worsen the opioid epidemic and kill people needlessly", Dr. Sidney Wolfe, founder and senior adviser of Public Citizen's Health Research Group, said in a statement. That might allow the agency to turn down future applications for new opioid approvals if the drugs are not filling an unmet need. The Defense Department paid for R&D activities for Dsuvia through a 2015 contract in search for a replacement to using morphine injections, according to AcelRx's Securities and Exchange Commission filings.

More: The opioid crisis hits home. Diversion, of course, is the term used to describe how drugs end up in the hands of someone other than the intended patient.

Gottlieb also points out in his statement that it can help in special circumstances in which a patient may not be able to swallow, adding that there could be potential uses on the battlefield. The medication is called DSUVIA; it is a single-dose 30 mcg sublingual tablet of sufentanil. And many of those will overdose and die.

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"The FDA has made it a high priority to make sure our soldiers have access to treatments that meet the unique needs of the battlefield, including when intravenous administration is not possible for the treatment of acute pain", Gottlieb wrote. Most of that was the result of a record number of opioid-related deaths.

Including brand name and generic drugs, there are almost 400 opioids now on the market. "DSUVIA will only be distributed to health care settings certified in the DSUVIA Risk Evaluation and Mitigation Strategy (REMS) program following attestation by an authorized representative that the healthcare setting will comply with appropriate dispensing and use restrictions of DSUVIA", AcelRx said.

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