The FDA Was Wise to Approve a New Opioid: The use of Dsuvia is limited, and wounded soldiers need it.

Wall Street Journal, November 7, 2018

By Sally Satel

The Food and Drug Administration last week approved Dsuvia, a powerful new opioid. The typical scenario for use is in wounded soldiers being transported off the battlefield who lack intravenous access for an injection or drip and who cannot swallow medication. Using a syringe-like applicator, medical personnel place the quickly dissolving pill under the patient’s tongue.

A new analgesic option for American soldiers in terrible pain should be greeted as a pharmaceutical win. But Dsuvia has come under attack. It contains sufentanil, a synthetic opioid as much as 10 times as powerful as fentanyl and about 1,000 times as potent as morphine.

“I just don’t believe at this point in the U.S. that there is any good reason to put another potent opioid on the streets,” said Raeford Brown Jr., a professor of anesthesiology and pediatrics at the University of Kentucky who chairs the FDA’s Anesthetic and Analgesic Drug Products Advisory Committee. Despite his warnings, the advisory committee voted 10-3 to recommend approval.

“It is certain that Dsuvia will worsen the opioid epidemic,” said Sidney Wolfe, founder of Public Citizen’s Health Research Group. Massachusetts Sen. Ed Markey has called on the FDA to “stop the approval of this dangerously unnecessary opioid medication.”

They’re wrong-the FDA made the right call. Dsuvia won’t be “on the streets” but available only in inpatient settings. Outpatient pharmacies won’t stock it. Patients cannot take it home. The recommended limit on administration is three days. The only realistic potential abusers of Dsuvia are medical personnel, who have had access to liquid sufentanil from hospital pharmacies since the drug was approved in 1984 for intravenous and epidural use.

The dangerous hyperpotent drugs now on the street-fentanyl and carfentanil, which is 100 times as potent and used to tranquilize large animals-are manufactured illicitly in China and Mexico. For the past four years, heroin and fentanyl have been the overwhelming drivers of overdose deaths.

An odd calculus marks the Dsuvia controversy. Critics say that benefit to soldiers in excruciating pain is outweighed by risk to hospital personnel who might deliberately abuse it-the very professionals who have sworn to do no harm and who already have direct access to this drug and others.

Protecting the public from drug abuse and addiction to opioids, licit and illicit, requires perspective. The proper response to health-care professionals who abuse opioids is addiction treatment and disciplinary action by state health boards, not restriction of the drug from patients in need.

Dr. Satel is a resident scholar at the American Enterprise Institute, and a lecturer in psychiatry at Yale.