On Nov. 2, the Food and Drug Administration approved the opioid Dsuvia, a sublingual tablet (it is placed under the tongue until it dissolves, providing faster pain relief than intravenous or swallowed tablet painkillers) five-to-10 times stronger than fentanyl (itself 100 times as strong as morphine and 50 times as strong as heroin).

Critics of the approval are worried that adding such a powerful opioid to the market may exacerbate the Opioid Crisis that caused more than 49,000 deaths in 2017 alone. That epidemic started with legal opioid painkillers such as oxycodone and hydrocodone and—when stricter controls made those too hard to get—progressed to heroin, fentanyl, and even carfentanil.

However, proponents of Dsuvia counter that:

  • Dsuvia is just another formulation of sufentanil, an IV drug that is necessary for situations when neither swallowing a pill or IV administration is practical (under battlefield conditions or when a vein cannot be found)
  • A strong opioid such as Dsuvia is necessary for patients who are already on opioids for chronic pain and have developed a tolerance
  • Dsuvia will be very strictly controlled, so
    • No pharmacy prescriptions
    • Only available in a single-use, single-dose package
    • Only available to doctors in a medical center setting (or the military)

Besides, oxycodone and hydrocodone diversion has been greatly reduced under strict controls, which has fueled a rise in heroin and fentanyl abuse. Fentanyl also is a prescription medicine, but its misuse isn’t the result of diversion but smuggling and creation: it is relatively easy to synthesize.

So, stricter controls on legal medicines make illegal drugs easier and cheaper to come by. The European Medicines Agency had already approved Dsuvia as Dzuveo. The cat is out of the bag.

The concern over Dsuvia is partly because of how badly Big Pharma, the FDA, and the Drug Enforcement Agency dropped the ball on drugs such as OxyContin by claiming or concluding that they didn’t pose a high risk for addiction. Many state attorney generals are not considering lawsuits.

It is exacerbated further by what some say is the too-quick and too-hasty approval by the FDA and the fact that the FDA’s Drug Safety and Risk Management Advisory Committee and Dr. Raeford Brown, an anesthesiologist at the University of Kentucky and chair of the FDA’s Anesthetic and Analgesic Drug Products Advisory Committee—a key opponent—were not included in the deliberation process. That could look like they were excluded on purpose.

A cynically inclined individual might even suspect that Dsuvia is needed not by doctors and pain sufferers but by the pharmaceutical company because sufentanil is no longer under patent but its Dsuvia formulation will be. (A transdermal sufentanil patch also is in development or up for approval.) The company says it anticipates more than $1 billion a year in sales. Dsuvia is expected to go on sale in the first quarter of 2019.

Dsuvia may be safe from diversion and addiction, but then no one expected fentanyl to become such a large part of the illegal drug market. If fentanyl can be synthesized, so, too, many Dsuvia. The FDA must keep a close eye on it. If it becomes responsible for many deaths, it should be recalled or voluntarily withdrawn from the market like Opana ER before it.

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