Dr. Marc Siegel: Why is the FDA approving a powerful new synthetic opioid in the midst of a crisis? Here’s why

A U.S. Army Blackhawk medevac helicopter arrives with wounded soldiers at the 31st Combat Support Hospital in Baghdad, Iraq Tuesday, Nov. 9, 2004. (AP Photo/John Moore) (AP)

It is over 200 years since F.W. Serturner isolated a crystalline substance from opium that he called morphium. Morphine and its derivatives (heroin was first developed by Bayer in 1898) have been used ever since to manage severe pain in cancer patients, agony from wounds on the battlefield, and even mild discomfort from persistent coughing.

Also from the beginning, the danger of abuse and addiction have accompanied these drugs’ extraordinary usefulness. The powerful drug Fentanyl was introduced more than 50 years ago, and immediately became a mainstay of both intra-operative pain management as well as a highly effective treatment for cancer pain. With Fentanyl too, there was a big upside along with a highly addictive dark side.

Now along comes a new synthetic opioid, Dsuvia, just approved by the FDA that is a thousand times more powerful than morphine and ten times more powerful than Fentanyl. At first it may seem contradictory to approve a drug like this at a time of opioid curtailment.

In fact, Dr. Scott Gottlieb, FDA Commissioner, acknowledged this, releasing a statement saying that while approving Dsuvia, the FDA “should evaluate whether we need to take additional steps to systematically consider new opioids relative to the comparative benefit and risks of other opioids already on the market.”

“For civilian use it’s restricted to inpatient hospitals and we have in place tight restrictions that we believe will mitigate the potential for abuse,” Gottlieb stated.

He continued, stating, “We should consider whether we could do more in weighing approvals to ensure that new opioids are sufficiently better than existing drugs to justify their addition to the market in the context of the current crisis of abuse.”

So the question is how does Dsuvia fit that bill? Fentanyl (and similar compounds) led to close to 30,000 of the 72,000 drug overdose deaths in the U.S. last year alone, and Dsuvia is ten times more powerful than Fentanyl. The potential for abuse and fatal overdose would seem to be quite high, especially when you consider that illicit chemists outside the U.S. in China and Mexico have already created a growing market for massively powerful and deadly drugs based on Fentanyl.

Here is the answer: Dsuvia serves a purpose that no other opioid does – therefore, it fulfills the FDA’s new criteria for approval.

As FDA chief Gottlieb told me in an exclusive statement, “This drug serves a potentially important medical niche providing an alternative for rapid pain relief in austere settings like the battlefield. For this reason, the product was a priority for the defense department and its development was a part of our collaboration with the Pentagon.”

Consider a wounded soldier in tremendous pain from an IED going off. The amount of blood lost may make intravenous access temporarily impossible, and the soldier certainly can’t swallow a pill while semi-unconscious. Dsuvia can relieve agony from multiple fractures or even the loss of a limb while the patient is being stabilized and brought to a MASH unit.

Though developed for the military, Dsuvia has important civilian uses as well, especially when restricted to physician administration in hospital or ambulatory surgery settings, as the FDA is doing.

Here the most likely use would be in pre or post-surgical patients where intravenous access is a problem. “For civilian use it’s restricted to inpatient hospitals and we have in place tight restrictions that we believe will mitigate the potential for abuse,” Gottlieb stated. These restrictions include pre-filled syringes and a limit of 72 hours. The FDA is also on the lookout for misuse and potential for fatal overdose. “We’ll monitor its use closely and intervene if new risks emerge,” he said to me.

At the same time that it is approving powerful new opioids with very strict therapeutic indications, the FDA has also been clamping down on misleading websites that promote unapproved opioids. It is also considering and approving opioid alternatives for pain, limiting prescriptions, providing education, and extending the use of opioid antidotes (medically assisted therapy).

The FDA is pushing to have easily abused opioids from the market, and even extending the scrutiny to opioid overuse in animals.

In sum, the FDA is part of the ongoing battle against the opioid epidemic. Dr. Gottlieb in particular, is an effective warrior in the fight. Dsuvia’s approval is a medical decision, not a political one, and does not undermine the progress that is being made. Just the opposite: We need to replace the excess overuse of some opioids like Oxycontin or Vicodin with the responsible effective use of Dsuvia and others.