Amid Deepening Addiction Crisis, FDA Approves Powerful New Opioid Dsuvia

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That said, Gottlieb still acknowledged the concerns and criticisms over the approval, as well as how it opened a broader discussion about FDA policy about opioids. Indeed, its potential use by soldiers was one reason Dsuvia was approved, according to FDA Commissioner Dr. Scott Gottlieb. And many of those will overdose and die.

But Dsuvia's approval comes amid controversy, with an epidemic of opioid abuse continuing to ravage the United States. "I recognize that the debate goes beyond the characteristics of this particular product or the actions that we're taking to mitigate this drug's risks and preserve its differentiated benefits".

"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", he said.

But the criticism was quick.

But critics of the drug and its potency - it's 10 times stronger than fentanyl - are tired that such a pill could add to the country's already alarming opioid epidemic.

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"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.

Dsuvia will not be available at retail pharmacies or for any home use, Gottlieb said. As part of the program, the drug maker will monitor distribution and audit wholesalers' data, evaluate proper use in the healthcare setting, and monitor for diversion or abuse and decertify any healthcare setting that is noncompliant. Advisors had warned that the opioid could be ill-used and would lead to more overdose deaths.

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.

The statement noted the benefit the drug could have for soldiers injured on the battlefield. DSUVIA was developed by AcelRx in collaboration with the Department of Defense, which sought a strong, non-invasive pain medication for battlefield injuries. Sufentanil has historically been primarily administered through an IV. It is restricted to being used in certified medically supervised health care settings like hospitals, surgical centers, and emergency departments. Dsuvia was approved by the European Medicines Agency in June under the name Dzuveo.

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.