The FDA endorsed Dsuvia, which can be applied once under the tongue and benefit soldiers on the battlefield where IVs can be impractical.
"To what extent should we evaluate each opioid exclusively on its own merits, and to what extent should we also consider. the epidemic of opioid misuse and abuse that's gripping our nation?"
Dsuvia will not be available at retail pharmacies or for any home use, Gottlieb said.
Sanjay Gupta that opioids are the biggest crisis facing the nation, a crisis fueled by overprescribing.
Dsuvia (sufentanil) is an exceptionally powerful opioid, roughly 1,000 times stronger than morphine and more potent than fentanyl. 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. And it should only be administered by a health care provider using a single-dose applicator. Gottlieb noted Dsuvia was "a priority medical product for the Pentagon" and the military's use "was carefully considered in this case".
The New York Times: F.D.A.
FDA Commissioner Scott Gottlieb announced approval of AcelRx Pharmaceuticals' painkiller Dsuvia Friday, an announcement that largely went under the public's radar, except for a swift denouncement by U.S. Sen.
The FDA announced its approval November 2 of a new prescription opioid called Dsuvia, despite public and medical criticism for the drug's approval in the midst of the opioid epidemic, according to STAT.
A new tablet form of an ultra-powerful opioid is about to make its way into hospitals, despite the ongoing opioid crisis plaguing the U.S.
"We won't sidestep what I believe is the real underlying source of discontent among the critics of this approval-the question of whether or not America needs another powerful opioid while in the throes of a massive crisis of addiction", Gottlieb's wrote. It'll also help them evaluate the risk of a drug being misused or abused and also the unique benefits of the drug to the people in pain.
The company producing Dsuvia, AcelRx, argued it would be an "important non-invasive, rapidly acting alternative to IV opioids". Alan says the concern around the drug is "valid given the potential for abuse".
But this wasn't an Federal Bureau of Investigation sting or DEA operation.
Drug overdose deaths hit the highest level ever recorded in the United States a year ago, with an estimated 200 people dying per day, according to a report by the U.S. Drug Enforcement Administration. Part of that effort may be a closer and more stringent assessment of the need for new opioid formulations going forward, Gottlieb added. The numbers say it all: More people die in the USA each year from drug overdoses than from breast cancer.