DSUVIA: A New FDA-Approved Drug More Potent (and Dangerous) Than Fentanyl

Just last month, the U.S. Food and Drug Administration (FDA) approved DSUVIA™, a new pain-relieving drug consisting of the opioid agonist, sufentanil. Sufentanil is a Schedule II controlled substance. It is also 5 to 10 times more potent than fentanyl, the dangerous opioid drug that has been fueling the nation’s opioid overdose crisis.

It’s no wonder, then, why there is question as to why this drug was approved by the government. After all, an average of 115 Americans are dying every day from an opioid overdose. Why bring more dangerous, more potent opioids into the mix?

Dsuvia is the first and only drug of its kind – a sublingual (dissolvable, under the tongue) tablet of sufentanil, that is administered through a disposable, pre-filled, single-dose applicator. According to the FDA, Dsuvia is for the management of acute pain that is “severe enough to require an opioid analgesic and for which alternative treatments are inadequate.” Currently, the medicine can only be used for adults, in certified medically-supervised health care settings ‒ such as hospitals, surgical centers and emergency departments ‒ and only by a certified healthcare professional. It is not available in outpatient centers or pharmacies, reports the FDA, and therefore has less room for addiction and abuse.

According to FDA Commissioner Dr. Scott Gottlieb, there are “unique aspects” of Dsuvia that make it a welcome addition to the medical field, including that the drug will be especially useful for soldiers who cannot obtain intravenous opioids for acute pain. The benefits of Dsuvia (in a medical setting) include that it is fast-acting for rapid pain reduction, and also easy to administer, as opposed to current oral and IV opioid analgesics.

But does the benefit outweigh the risks, is still a question to be answered. Fentanyl was once a drug administered as an IV in medical establishments, such as hospitals, and prescribed in lozenges or patches to help manage acute pain. Over the years, however, fentanyl started to be produced illicitly all over the world. Now, many of the most commonly abused drugs are being laced with fentanyl – a drug 100 times more potent than morphine, with fast- and fatal effects, causing a long and unending string of overdoses throughout the country. Drug treatment experts, along with parents, educators, and authorities, are all wondering if illegal sufentanil (Dsuvia) will come next. And what will that mean for the opioid epidemic?

Dsuvia is 500 to 1,000 times more potent than the opioid drug morphine, and 250 to 800 times more potent than illicit heroin. If, by any means, Dsuvia gets diverted from hospitals to the streets, there is a great potential for abuse, addiction, and overdose. According to Massachusetts’ Democratic Senator Ed Markey, “An opioid that is a thousand times more powerful than morphine is a thousand times more likely to be abused and a thousand times more likely to kill.”

Others express similar concerns about the new drug, Dsuvia. Dr. Raeford Brown, chair of the FDA advisory committee on analgesics and anesthetic drug products, even has significant concerns about the drug. Dr. Brown was not present during the approval of Dsuvia, but stated in the Public Citizen press release that he was “very disappointed by the decision.” He explained to ABC News:

“It doesn’t seem reasonable to place another potent opioid on the market at this time, especially when we’re currently still writing 200 million prescriptions for opioids a year… We know from looking at other potent opioids that have been put on the market in the last four years that once these drugs get past the FDA, there’s very little, if any, control over them, no matter what the sponsor says prior to the time they come on the market.”

According to Dsuvia’s creators, AcelRX, the drug will only be distributed to healthcare settings certified in the Dsuvia Risk Evaluation and Mitigation Strategy (REMS) program. As part of the REMS program, AcelRx says they will monitor distribution and audit wholesalers' data, evaluate proper usage of Dsuvia within the healthcare settings, and monitor for any diversion and abuse, de-certifying any healthcare settings that are non-compliant with the REMS program.

People who take a prescription opioid are 40 times more likely to develop an addiction to an illicit opioid, according to treatment sources. Even in a medical setting, opioid medications have addictive qualities that cannot be overlooked. Dsuvia should not be used for more than 72 hours, likely for this very reason, though AcelRX has not studied the use of Dsuva beyond that 72-hour mark.

Dsuvia is brand-new and as a result, needs to be monitored, tested, and analyzed for effectiveness as well as addiction and abuse. Without a doubt, the recent approval of this new drug does raise severe concerns about the state of the nation’s opioid crisis, and questions as to whether we’ll ever climb out.

If you or someone you love is in need of help or seeking opioid addiction treatment, please do not hesitate to reach out. Turnbridge is here for you, to answer your questions, ease your concerns, and help you find the help you need. Call 877-581-1793 to learn about our opioid addiction treatment programs in Connecticut.