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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. And in doing so, the agency addressed wider regulatory thinking for endorsing such a medicine amid nationwide angst about overdoses and deaths attributed to opioids.
The drug is called Dsuvia, which is a tablet version of an opioid marketed for intravenous delivery, but is administered under the tongue using a specially developed, single-dose applicator. These “unique features” make the medicine well-suited for the military and therefore was a priority for the Pentagon, a point that factored heavily into the decision, according to FDA Commissioner Scott Gottlieb.
Although an FDA advisory committee last month recommended approval, the agency was urged by critics not to endorse the drug because it is 10 times more powerful than fentanyl, a highly addictive opioid. Among those who those who opposed approval were four U.S. senators and the FDA advisory panel chair, who could not attend the meeting, but took the rare step of later writing a letter to the agency.
The objections included complaints that Dsuvia has no unique medical benefits and might be easily diverted by medical personnel, despite a risk mitigation plan the manufacturer, AcelRx Pharmaceuticals, must maintain. There was also criticism the FDA failed to convene the Drug Safety and Risk Management Advisory Committee, not just the Anesthetic and Analgesic Drug Products Advisory Committee. Last year, the FDA refused to approve the medicine over concerns about usage directions and a need for additional safety data.
originally posted by: LightSpeedDriver
a reply to: dug88
Sufentanil (Dsuvia) is 500 times more powerful than morphine. It sounds scary to my non-medically trained ears. Hopefully it will not become available on the black market because people who don't know it is 500 times stronger will die.
Currently sufentanil is the strongest opioid painkiller available for use in humans. Although stronger narcotic pain medications do exist, all medications stronger than sufentanil are approved for veterinary use only.
originally posted by: threeeyesopen
a reply to: Cobaltic1978
I dont doubt its effectiveness and I dont doubt I'd be screaming for something too. I just question the rush on getting it in use thats all.
originally posted by: toms54
a reply to: dug88
Maybe if the military has this drug we won't need to guard the opium crop against the Taliban in Afghanistan anymore.
Why else are we over there anyway? To keep out the Chinese? c'mon. This whole opiate epidemic began when we went over there. Just like the smuggling from the golden triangle during Vietnam. CIA claims they only sell to Russia and Kazakhstan.