FDA attacked for OK'ing a painkiller stronger than morphine

FDA approves powerful opioid despite fears of more overdose deaths

FDA approves powerful opioid despite fears of more overdose deaths

"We won't sidestep what I believe is the real underlying source of discontent among the critics of this approval-the question of whether or not America needs another powerful opioid while in the throes of a massive crisis of addiction", Gottlieb's wrote.

In a highly controversial move, the Food and Drug Administration approved an especially powerful opioid painkiller despite criticism that the medicine could be a "danger" to public health.

The product, Dsuvia, consists of the synthetic opioid sufentanil, which is 500 times stronger than morphine, packaged in a plastic applicator for faster pain relief. Also, Dr. Palmer argues that risk for abuse is low because it must be administered-again, by a health care professional in a controlled medical center setting-under the tongue.

"The agency is taking new steps to more actively confront this crisis, while also paying careful attention to the needs of patients and physicians managing pain", he said.

FDA Commissioner Scott Gottlieb issued an unusual statement saying he would seek more authority for the agency to consider whether there are too many similar drugs on the market, which might allow the agency to turn down future applications for new opioid approvals.

One factor that weighed heavily in the Dsuvia decision is military interest in the drug, Gottlieb said in his statement.

Sidney Wolfe of Public Citizen's Health Research Group, a consumer group, called Gottlieb's statement "empty rhetoric" and said the agency missed a big opportunity when it approved the pill. Most of that was the result of a record number of opioid-related deaths.

The drug, Dsuvia, is a quick-dissolve tablet designed as an alternative to the rapid-fire infusion of pain meds available via IV at a hospital. According to the administration, prescription opioids were responsible for the most overdose deaths of any illicit drugs since 2001.

For Dsuvia specifically, Gottlieb referenced the opioid multiple times as a Pentagon priority, citing its potential use on the battlefield to treat soldiers through its sublingual formulation. An estimated 51 million of these visits are to emergency departments (ED), with an estimated 18 million of these ED patients receiving an IV only for pain management.

Dsuvia was rejected by an FDA advisory committee in 2017 because the committee wanted more data.

AcelRx Pharmaceuticals, in a statement, said the drug was long in the making. It is expected to be available in the first quarter of next year.

Supporters of the drug also argue that even though sufentanil is known to be very potent, the effective dose of Dsuvia is a tiny, premeasured 30 mcg. Leiman was a researcher on an AcelRx study of Dsuvia in post-surgical patients.