Opioid Hysteria and the Demonizing of Dsuvia

By John Burke, Guest Columnist

Recently the FDA approved a new sublingual formulation of sufentanil -- called Dsuvia -- for the management of moderate to severe acute pain in hospital-like settings. This would include surgical centers and emergency departments.

When the FDA announced this approval, several so-called experts claimed that Dsuvia – which is a potent opioid – would worsen the already out of control opioid problem. They said it would quickly find its way to the streets of America and kill even more of our citizens addicted to opioids. They can’t imagine why the FDA would approve such a killer drug!

Dsuvia was originally developed by AcelRx Pharmaceuticals, in cooperation with the U.S. Department of Defense, to treat battlefield wounds. The single dose formulation is designed to enter your body and provide pain relief faster than the traditional intramuscular injections that are now standard in treating traumatic injuries.

I can only imagine the horrendous wounds that are present on the battlefield. Offering faster pain relief seems like a great option, to say the least!  

ACELRX PHARMACEUTICALS

Dsuvia will also be used in our nation’s emergency departments and other healthcare facilities to offer faster pain relief to patients who suffer traumatic injuries. The drug will not be available in retail pharmacies or for most prescribers to order up for a patient. Doctor shoppers, script scammers and others that prey on retail pharmacies will have no access to this pain reliever. Those involved in armed robberies or burglaries of retail pharmacies will also have zero access.

Who will have access to Dsuvia are healthcare employees -- nurses, doctors and other medical professionals who already have access to a whole host of opioid drugs. There is no question that Dsuvia could potentially be a target of a small group of professionals who suffer from addiction problems. However, the illegal diversion and sale of this specific medication seems less likely in healthcare facilities.

Dsuvia will be more easily identified when it is diverted due to its limited availability and usage. Addicted healthcare employees will likely opt for more commonly used opioids like morphine and hydromorphone rather than a rarely used medication that will be easily missed when diverted.

The other part of this equation, that was either not considered by critics or didn’t suit their narrative, is that diversion inside healthcare facilities virtually always involves self-addiction. This means that even if an opioid is stolen by an employee inside one of these facilities, it will rarely make it to the street and cause more deaths.  

AcelRx has already developed a Risk Evaluation and Mitigation Strategy (REMS) involving RADARS, a nationwide drug abuse surveillance system, to monitor any diversion of Dsuvia and provide quarterly reports to law enforcement. In the interest of full disclosure, I am on the Scientific Advisory Board of RADARS.

Dsuvia has great potential to provide quick relief to trauma patients in a focused setting. Its diversion potential, especially to the public, is almost nil. Demonizing a drug without any real knowledge of its legal distribution and potential for diversion is irresponsible to say the least.

The drug problem in America primarily involves street drugs such as heroin, illicit fentanyl, and more recently crystal methamphetamine and cocaine. Even as the prescribing of opioids has dropped over 30% in recent years, drug deaths continued to rise. The reason is the increased supply of street drugs supplied by cartels that continue to profit from our nation’s addiction.

Put the blame where it belongs, and don’t ostracize a legitimate new pain drug that any of us might need in an emergency.

John Burke spent nearly 50 years in drug and law enforcement in southwestern Ohio. John is a former president of the National Association of Drug Diversion Investigators and is the president and founder of the International Health Facility Diversion Association, a non-profit devoted to the issues surrounding the diversion of controlled substances from healthcare facilities.

The information in this column should not be considered as professional medical advice, diagnosis or treatment. It is for informational purposes only and represent the author’s opinions alone. It does not inherently express or reflect the views, opinions and/or positions of Pain News Network.

Zohydro 'Not a Public Health Risk'

By Pat Anson, Editor

Eighteen months after the introduction of Zohydro, there is little evidence the controversial painkiller is being abused or diverted, according to a new report from a nationwide drug monitoring program.

"Zohydro is not a public health risk and has shown little tendency to increase over the time it has been available," stated the report by the Researched Abuse, Diversion and Addiction-Related Surveillance System (RADARS). "The drug is either not desirable or unavailable for abuse."

The report covered the first quarter of 2015. RADARS monitors hundreds of hospitals, poison control centers and addiction treatment clinics in the U.S. to track the abuse, misuse and diversion of prescription drugs.

"Everyone thought this was going to be some horrible, horrible thing. And it didn't materialize that way," said Errol Gould, PhD, Director of Medical Affairs for Pernix Therapeutics, which bought the rights to Zohydro from Zogenix Inc. earlier this year.

"There have been very few reports of people checking into treatment centers and reporting Zohydro ER as the drug they were abusing. In the past 18 months I can tell you there have been less than 40."

There was a storm of controversy surrounding Zohydro when it was introduced in March 2014. The first single ingredient  hydrocodone painkiller sold in the U.S. was approved by the Food and Drug Administration over the objections of its staff and an advisory committee -- which warned there was a potential for Zohydro to be abused even more than other hydrocodone products.

Addiction treatment experts also predicted Zohydro would fuel a new wave of painkiller addiction and overdoses. The Governor of Massachusetts even declared a state of emergency and tried unsuccessfully to ban Zohydro sales in his state.

"All the media attention sort of scared people, so there weren't a lot of prescriptions written in the beginning," said Gould. "But now over time the prescription rate has picked up. But we're still not seeing diversion. The abusers already know what hydrocodone is like and they're not going out and looking for Zohydro when they can get other things that are more readily available to them."

Only about 1,600 prescriptions are being written for Zohydro each week, a tiny fraction of the 130 million hydrocodone prescriptions that are filled each year in the U.S. Prescribing of Zohydro is also closely monitored to keep it away from pain patients who might misuse or abuse it.

"I think the growth has been slow. Most of that has been because of the prior perceptions. We fully expect that to change over time. It just takes time to change people's views and minds. We've had a bit of an uphill battle," said Doug Drysdale, President and CEO of Pernix. "The good news here from RADARS is that the product is not being abused. And I think that's very encouraging."

The biggest problem faced by Pernix going forward may not be the hysteria over Zohydro's introduction -- but competition from rival drug makers.

Purdue Pharma has introduced its own "pure" hydrocodone product -- sold under the brand name Hysingla ER. Hysingla is designed to be taken once a day, while Zohydro is meant to be taken twice daily for chronic pain. Both products are sold in abuse deterrent formulas that make them harder for drug abusers to snort or inject.

Until the introduction of Zohydro, most hydrocodone products on the market were combined with acetaminophen, which at high doses can cause liver damage. Hydrocodone combination drugs such as Vicodin, Lortab and Lorcet are the most commonly prescribed and abused painkillers in the U.S. In 2014 hydrocodone was reclassified by the Drug Enforcement Administration as a Schedule II medication to make it harder to obtain.