FDA OKs powerful opioid pill as alternative to IV painkiller

FDA OKs powerful opioid pill as alternative to IV painkiller

FDA OKs powerful opioid pill as alternative to IV painkiller

"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 said in his written statement.

More importantly, though, some critics argue that the drug's size (about 3mm wide) and potency (at least 10 times more powerful than fentanyl) will certainly have more appeal to those looking to misuse/abuse the drug or to sell it.

Gottlieb said Dsuvia, which is administered under the tongue through a disposable, pre-filled, single-dose applicator, "is 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".

"The agency is taking new steps to more actively confront this crisis, while also paying careful attention to the needs of patients and physicians managing pain", he said.

"This new opioid will soon be hitting the market in the middle of the worst drug crisis this country has ever seen", the Bay State senator said. 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.

Sidney Wolfe of Public Citizen's Health Research Group, a consumer group, called Gottlieb's statement "empty rhetoric" and said the agency missed a big opportunity when it approved the pill. This includes potential uses on the battlefield.

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"DSUVIA will not be available in retail pharmacies or for outpatient use".

The sublingual administration makes Dsuvia an option for patients with nothing by mouth (NPO) status and patients with hard IV access (obese, elderly, burn or needle-phobic patients), according to the statement.

According to the FDA's statement, the drug was designed for military use, and while no one wants soldiers to suffer, some may argue that in the war against opioid-related overdoses, there are plenty of battlefields right here at home-with more than 115 people dying after overdosing on opioids every single day in the United States.

"I am very disappointed with the decision of the agency to approve Dsuvia".

The manufacturer, a California company called AcelRx, will market the drug beginning in early 2019 under the name Dsuvia, at a wholesale price of $50 to $60 per dose.

The Food and Drug Administration on Friday approved a new form of an extremely potent opioid to manage acute pain in adults, weeks after the chairman of the advisory committee that reviewed it asked the agency to reject it on grounds that it would likely be abused. AcelRx returned to the committee this year, and on October 12 the drug was recommended for approval. Leiman was a researcher on an AcelRx study of Dsuvia in post-surgical patients.

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