New Opioid Approval Creates Controversy

Outcry Over Dsuvia’s Availability Is Overblown, Given the Safeguards in Place for This Pain Medication.

A blurb came across my desk in early November concerning the FDA’s approval of the drug Dsuvia, a sublingual sufentanil tablet designed for individuals with extreme acute pain and to be used only in medically supervised health care settings. This means, of course, that it will not be prescribed outside the health care setting, and it will not be present in retail pharmacies.

The outcry occurred almost immediately. Politicians and other critics could not believe that the FDA would approve such a potent opioid, given the addiction and overdose crisis.

“It is certain that Dsuvia will worsen the opioid epidemic and kill people needlessly,” Sidney Wolfe, MD, cofounder of and senior advisor to nonprofit Public Citizen’s Health Research Group, said in a statement.

“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,” Sen Ed Markey (D-MA) said in a separate statement.

Those are incredible statements about a drug that is to be used only in health care settings under strict supervision. In addition, the FDA is requiring Dsuvia’s manufacturer, AcelRx, to conduct a Risk Evaluation and Mitigation Strategy to accompany the drug approval. AcelRx has already contracted with Denver Health’s RADARS system, a group of programs used to monitor prescription diversion and drug abuse and misuse. The RADARS system is a program that I have been a part of for many years with the Science Advisory Board.

The RADARS system will put the new drug into a group that is monitored by several surveys, one of which is the drug diversion survey. This survey is compiled by several hundred law enforcement agencies across the country that report to the system quarterly. If Dsuvia shows up in the hands of law enforcement, it will be easily and quickly identified. I do not expect that to happen, but it is one example of the safeguards that will accompany the drug.

It is unlikely that Dsuvia will be diverted and end up on the street. It is designed to be used inside supervised health facilities and is not available on the retail market and therefore not in retail pharmacies, where it could be easily obtained through an armed robbery or other theft.

Dsuvia is designed to be put under the tongue to deliver almost immediate pain relief to individuals in excruciating acute pain. This could be especially important for those going to an emergency department (ED) with unbearable pain, hoping for a quick and effective way to mitigate their misery.

“For acute pain management in a hospital, there hasn’t been a new opioid developed for many years,” Pamela Palmer, MD, chief medical officer at AcelRx, told ABC News. “Right now, if you broke your femur and went into an emergency [department], you would either be stuck with a needle or they would just give you an oral pill that you would swallow and kind of wait for it to kick in, which could take up to an hour.”

The most likely type of diversion of Dsuvia would be by addicted health care professionals inside the hospital. This certainly can happen, but these offenders have many other options to satisfy their addiction, and the probability of the drugs’ leaving the facility is virtually nil. Instances of diversion by these health care professionals are almost exclusively self-addiction situations that do not affect others.

Although many people are up in arms about Dsuvia’s approval, the bottom line is that Dsuvia is a needed drug that can assist countless patients suffering from excruciating acute pain, and it has a low potential for diversion.

I certainly do not want another opioid in the retail pharmacy ready to be exploited as others have been for decades. However, when an important pain drug serves a niche in our EDs or on the battlefield, I want legitimate patients to have access to credible pain management, and the quicker the better.

Let’s not cry that the sky is falling just because the FDA approves a new opioid. Instead, we should calmly assess the new medication and try to understand how it might be used responsibly and with the least possibility of diversion.

Cmdr. John Burke is a 40-year veteran of law enforcement, the past president of the National Association of Drug Diversion Investigators, and the president and cofounder of the International Health Facility Diversion Association. He can be reached by email at burke@rxdiversion.com or via rxdiversion.com.