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 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.
I agree. This drug should not be approved. Sorry surgery patients and cancer patients that are still undertreated for pain. We need to focus on the 2% of the population thar abuses drugs so you’ll have to suffer. With our efforts to reduce and control the use of pharmaceutical opioids we’ve cut … Ok no the death from opioids has increased but any day now our plan will work just like every war on drugs. Success is just around the corner.
If this product is sooooo bad…then just remove all opiates! (Sarcasm). This drug has many many benefits
Thank goodness I have brain tumor and opiod is all that helps
Yet the FDA sent a CRL for Trevena’s Oliceridine, a druge that is safe and more efficacious than morphine. Makes absolutely no sense. Oh well, I guess thats the world we live in.
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