The FDA just approved an opioid painkiller 10 times more powerful than fentanyl
07 November, 2018, 22:30
What makes this particular approval so interesting is that the drug has many outspoken critics.
A tiny pill more potent than 1,000 times the strength of morphine has been approved for use by the Food and Drug Administration.
The decision has met a lot of criticism because the opioid is 5-10 times more potent than pharmaceutical fentanyl.
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".
Critics, including the head of the FDA advisory committee that reviews pain-relieving products, are anxious about putting such a potent and addictive medication on the market in the midst of the U.S.'s opioid crisis. Approval of the drug was highly criticized; Raeford Brown, MD, chair of the FDA's Anesthetic and Analgesic Drug Products Committee, urged the FDA not to approve Dsuvia. In a lengthy statement, Scott Gottlieb, FDA Commissioner, said there will be "very tight restrictions" placed on its distribution and it is intended only for supervised settings like hospitals.
"It is certain that Dsuvia will worsen the opioid epidemic and kill people needlessly", Sidney Wolfe, founder of Public Citizen's Health Research Group, said in a statement.
Sanjay Gupta that opioids are the biggest crisis facing the nation, a crisis fueled by overprescribing. Preliminary figures show more than 72,000 people died in 2017 from drug overdoses across the country.
"To address concerns about the potential risks associated with Dsuvia, this product will have strong limitations on its use", Gottlieb said.
The statement noted the benefit the drug could have for soldiers injured on the battlefield.
Brown, four U.S. Senators and the advocacy group Public Citizen have predicted that Dsuvia will be diverted to illicit use and cause more opioid overdose deaths. The drug, Dsuvia, is a tablet form of sufentanil, a synthetic opioid that has been used intravenously and in epidurals since the 1980s. For this reason, the Department of Defense (DoD) worked closely with the sponsor on the development of this new medicine. The study demonstrated that patients receiving the drug experienced significantly greater pain reduction versus placebo over the first 12 hours post-treatment.
AcelRx already has approval for 15- and 30-microgram versions of the drug in Europe. Leiman was a researcher on an AcelRx study of Dsuvia in post-surgical patients.
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.
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