Despite Addiction Worries, FDA Panel Quietly Approves a Stronger Opioid

Image of a rubber stamp that says "FDA Approved"

An FDA panel gave preliminary approval to a new kind of opioid drug meant to treat severe pain such as the kind people experience during surgery. The drug, sufentanil, which will be marketed under the brand name Dsuvia, is actually five to 10 times stronger than fentanyl.

Surprisingly, the drug advisory committee voted 10-3, approving the drug. While this doesn’t set approval in stone, the FDA usually follows the advisory committee’s instruction. While the FDA has been pushing for more restrictions on opioids, there was no mention of fears of addiction or overdose in the discussions.

There was one dissenting opinion, however; Raeford E. Brown Jr., MD, who chairs the committee. Dr. Brown doesn’t like the idea of allowing another potent and lethal opioid into the drug market, where fentanyl rules the day when it comes to accidental overdoses. He worries that some doctors won’t pay attention to dosing, which could also be dangerous.

With the approval, the pharmaceutical company itself is pretty thrilled to reveal a new product. “We are pleased with the advisory committee’s recommendation to approve Dsuvia as a treatment in medically supervised settings for adults experiencing moderate-to-severe acute pain,” said Pamela Palmer, chief medical officer and co-founder of manufacturer AcelRx.

“We believe Dsuvia represents an important noninvasive acute pain management option with potential to significantly improve the current standard of care.”

Sufentanil is a synthetic opioid that is supposed to be used for IV and epidural anesthesia. It is ingested as a pill that dissolves under the tongue. This new formulation of sufentanil was designed for rapid pain relief and takes effect in about 15 minutes. The drug itself lasts about three hours, making it ideal for surgeries.

The FDA had earlier mentioned two safety concerns to the manufacturer. They were worried about possible adverse effects in patients who require the maximum proposed dosing. They also worried that due to the small size, misplaced pills could be lethal who come across them or misuse them. The small size could have been deceptive to young people who experiment with drugs.

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