FDA Set To Approve Opioid 10x Stronger Than Pharmaceutical Fentanyl, Despite Objections of Head of Review Board


 
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BY ASRN STAFF

Despite opposition from the head of the committee that reviewed the drug, in a shocking victory for the drug industry, the FDA is set to approve a new, more powerful opioid, for use in hospitals and emergency rooms.

The FDA will decide this week, by November 3rd, whether to allow a California-based company to manufacture a 30 microgram pill form of sufentanil. The potent painkiller, a tiny pill, just 3 millimeters in diameter, is 5 to 10 times more potent than pharmaceutical fentanyl.

Despite more than 49,000 opioid overdoses in 2017, a record number of deaths, and hundreds of millions of doses of prescription painkillers getting diverted from the pharmaceutical supply chain to the streets, the drug was approved by an FDA advisory committee vote of 10-3 on October 12.

Strangely, the chairman of the committee, Dr. 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, and who had publicly urged the agency to reject the drug application, missed the meeting because he was out of town speaking at a medical conference in San Francisco that day.

The company, AcelRx,according to it's co-founder and chief medical officer, Pamela Palmer, is expected to manufacture the pill, Dsuvia, which would have the same impact as five milligrams of intravenous morphine.

The FDA doesn't comment on drugs under review.



 
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