WASHINGTON — The Food and Drug Administration is poised to approve a new form of a powerful opioid for use in hospitals and emergency rooms despite opposition from the head of the committee that reviewed the drug.

The FDA is scheduled to decide by Nov. 3 whether to allow a California company to produce a 30-microgram pill form of sufentanil, a potent painkiller commonly used after surgery.

An FDA advisory committee recommended approval of the drug in a 10-to-3 vote on Oct. 12. The FDA usually follows the guidance of those committees, which are comprised of experts on various drugs and medical devices.

But in this case, the chairman of the committee, who missed the meeting because he was speaking at a medical conference in San Francisco that day, has publicly urged the agency to reject the drug application because of the epidemic of opioid overdoses in the United States.

Raeford Brown, a professor of anesthesiology and pediatrics at the University of Kentucky who heads the FDA’s Anesthetic and Analgesic Drug Products Advisory Committee, sent his views in a letter to FDA Commissioner Scott Gottlieb and other agency officials. He also made his opposition public, a rare step for an FDA advisory committee chairman.

Brown said another potent painkiller is not needed in medical centers. The drug is five to 10 times more potent than pharmaceutical fentanyl. The tiny pill – just three millimeters in diameter – is all but certain to be diverted to the streets, he said. Brown also said the safety and effectiveness of the new drug has not been fully proven.

Sen. Edward Markey, D-Mass., and the advocacy group Public Citizen, which co-signed Brown’s letter to Gottlieb, also oppose FDA approval of the drug, which the company AcelRx would market as Dsuvia.

“This is a drug which is being proposed for approval at a time when we are trying to get the issues of opioid misuse and abuse under control in the United States,” Brown said in an interview.

“We have yet (to) be effective at preventing diversion of these opioids, and we try very hard.”


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