The Food and Drug Administration approved a powerful new opioid Friday for use in health care settings, rejecting criticism from some of its own advisers that it would inevitably be diverted to illicit use and cause more overdose deaths.
The product, Dsuvia, consists of the synthetic opioid sufentanil, which is 500 times stronger than morphine, packaged in a plastic applicator for faster pain relief.
Critics are blasting the FDA for approving Dsuvia as the country faces increasing opioid overdose deaths. 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.
The FDA is taking some precautions in the hopes that the drug will not be abused.
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. It would not be available in retail pharmacies. One stipulation of its stamp of approval was that the drug can only be administered within the walls of designated facilities like hospitals, surgical centers and emergency rooms, USA Today reported. The opioid in question is a highly potent, and risky drug that has more risks than benefits in health-care.
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The tiny pill was developed as an option for patients who pose difficulties for the use of IVs, including soldiers on the battlefield.
Additionally, four Democratic senators had urged Gottlieb to deny approval on Dsuvia until Brown and other drug safety committee members could participate in the decision and vote, in a letter they sent last Wednesday.
Drug overdose deaths hit the highest level ever recorded in the United States past year, with an estimated 200 people dying per day, according to a report by the U.S. Drug Enforcement Administration.
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. Leiman was a researcher on an AcelRx study of Dsuvia in post-surgical patients.
"As a single-dose, non-invasive medication with a rapid reduction in pain intensity, DSUVIA represents an important alternative for healthcare providers to offer patients for acute pain management", Dr. David Leiman, clinical assistant of surgery at University of Texas at Houston, said in a statement from AcelRx.
Emalie Gainey, a spokeswoman for state Attorney General Maura Healey, said Healey has "serious concerns" about Dsuvia and "will be monitoring this closely".