New FDA approved synthetic opioid serves a good purpose

New FDA approved synthetic opioid serves a good purpose
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The Fentanyl lollipop was co-invented by Dr. Ted Stanley in 1983 and hit the market in 1998 to treat cancer pain. At the time, this powerful treatment seemed to be extremely useful and humane. Unfortunately, by the time he died last year of prostate cancer, Stanley left behind a mixed legacy, because the Fentanyl lollipop is so easy to misuse and is so highly addictive.

In fact, of the more than 70,000 drug overdose deaths in the U.S. last year according to CDC, close to 30,000 were due to Fentanyl or related chemicals. Fentanyl is also made in a highly potent and addictive form by illicit chemists especially in China and Mexico

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Now along comes Dsuvia, a new sublingual synthetic opioid (injected under the tongue from pre-filled syringes), that is ten times more powerful than Fentanyl, with a seemingly high risk for abuse, addiction and overdose death.

At first glance, it would seem questionable that such a powerful opioid would be approved at a time when the FDA is trying to streamline approvals for opioids and make sure that they have completely justified medical uses especially when the abuse and addiction potential is high.

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Dsuvia fits this expectation to a tee. It was developed jointly with the FDA and the Pentagon for use on the battlefield. It was used for wounded soldiers when they were in agony and intravenous lines may not have been available or they were impossible to place. Dsuvia affords the battlefield surgeon or medic the opportunity to deliver instant pain relief where it might not otherwise be possible.

The same is true for civilian use, for severely injured trauma or surgical patients without easy intravenous access. It is significant that this drug is only approved for physician use in a hospital, emergency or ambulatory surgical center. It will not be available at your local pharmacy and it is not something you will be able to get a prescription for. This is as it should be and will likely limit the potential for abuse.

Still, the FDA intends to monitor Dsuvia closely and restrict use to 72 hours. “We’ll monitor its use closely and intervene if new risks emerge,” FDA Commissioner Scott Gottlieb said to me.

I believe this is the right approach. The out-of-control epidemic where physicians still vastly over prescribe opioids, even if the numbers are on the decline (191,218,272 in 2017 down from a high of 255,207,954 in 2012) remains at the core of the problem. Since prescribed opioids help to fuel the addiction/overdose crises, we physicians have a long way to go before we gain control. We need to learn other approaches for both identifying and treating pain. 

But keep in mind that Dsuvia will not be routinely prescribed and it will be highly controlled and supervised, in both the operating room and on the battlefield. This is the way towards the future. Not head-in-the-sand ostrich restrictive medicine but careful considered pharmacotherapeutics.

There is a difference between chronic pain and the acute pain of injury, wound, or fracture. Chronic pain is real but may be more subjective. Modalities including physical therapy, acupuncture, heat, chiropractic, yoga and less addictive non-narcotic medications have all been tried with some success.

Curtail the Oxycontin, Vicodin, Percocet gravy train for so-called chronic pain, but allow Dsuvia and drugs like it their proper medical niche for acute pain control.

Marc Siegel M.D. is a professor of medicine and medical director of Doctor Radio at NYU Langone Health. He is a Fox News medical correspondent.