Oct. 18, 2018 -- An FDA panel this week gave preliminary approval to a new kind of opioid for pain that is five to 10 times more potent than fentanyl. The drug advisory committee voted 10-3 to approve the drug, sufentanil, which would be marketed as Dsuvia. The panel vote is not the final step of approval, but the FDA regularly follows the committee’s lead.

"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," Pamela Palmer, MD, PhD, chief medical officer and co-founder of manufacturer AcelRx, says in a news release.

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

But at least one committee member feels quite differently.

Raeford E. Brown Jr., MD, a professor of anesthesiology and pediatrics at the University of Kentucky, who chairs the committee, says he is concerned about allowing an opioid as potent and potentially lethal as this one onto the market. He's also worried about the lack of appropriate education for doctors who might prescribe it.

"The FDA's inability to enforce controls, the potency of the drug, and the ease with which it will be diverted are some of the reasons why I would never consider this product for marketing in the U.S.," says Brown, who was unable to attend he committee’s meeting.

Sufentanil is a synthetic opioid that is used for IV and epidural anesthesia. It is a pill that dissolves under the tongue.

The new sufentanil formulation was designed for rapid pain relief. It can take effect in as little as 15 minutes and can last for about 3 hours.

AcelRx says the drug’s single-dose, prefilled, disposable packaging should prevent dosing errors and misuse.

The company says there's a need for opioid pain medicines that don't require swallowing, because some patients have difficulty taking oral medication and may not have access to IV opioids.

The FDA had earlier flagged two safety concerns. These include possible adverse effects in patients who require the maximum proposed dosing, and the risk for misplaced pills (they're small in size), which could contribute to abuse and accidental exposure. The company had submitted a new drug application for consideration.