FDA approves new painkiller, discusses future consideration of new opioids

The Food and Drug Administration Nov. 2 approved a new opioid drug called Dsuvia, which will be used to manage acute pain in adults. FDA Commissioner Scott Gottlieb, M.D., said that there are tight restrictions being placed on the distribution and use of the drug, which is 10 times stronger than fentanyl.
 
The drug will be restricted to use in certified medically-supervised health care settings ‒ such as hospitals, surgical centers and emergency departments ‒ for administration by a health care professional. It is formulated to be administered sublingually and may be particularly useful for battlefield injuries or other severe traumas where the the usual modes of administering pain medications are compromised.   
 
“Looking beyond this particular drug approval, I believe that we should consider whether we should be doing more to evaluate each candidate opioid, not just as an independent review decision, but rather also to consider each novel opioid drug in the context of the overall therapeutic armamentarium that’s available to patients and providers,” Gottlieb said. “As we look at the public health implications of each new approval, we should evaluate whether we need to take additional steps to systematically consider new opioids relative to the comparative benefit and risks of other opioids already on the market. We should consider whether we could do more in weighing approvals to ensure that new opioids are sufficiently better than existing drugs to justify their addition to the market in the context of the current crisis of abuse.”