FDA Approves DSUVIA Sublingual Synthetic Opioid Formulation & Delivery System

FDA approves new opioid

FDA approves new opioid

Officials with the FDA have approved a new opioid, (Dsuvia, AcelRx Pharmaceuticals), sparking some controversy in the media that the opioid has potential for abuse.

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.

The painkiller Dsuvia will be restricted to limited use only in health care settings, such as hospitals, surgery centers and emergency rooms, but critics worry the opioid will fuel an already grim opioid epidemic.

FDA Commissioner Scott Gottlieb issued an unusual statement saying he would seek more authority for the agency to consider whether there are too many similar drugs on the market, which might allow the agency to turn down future applications for new opioid approvals.

Dsuvia was rejected by an FDA advisory committee in 2017 because the committee wanted more data.

"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.

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

What makes this particular approval so interesting is that the drug has many outspoken critics. The opioid in question is a highly potent, and risky drug that has more risks than benefits in health-care.

The drug is intended for use within health-care settings and perhaps 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.

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.

The drug is also only for use by patients who can not tolerate other painkillers, or for whom other painkillers have failed or are expected to fail. Experts worry that supplies of the drug will somehow make their way from doctors' offices and pharmacies to addicts. "It is certain that Dsuvia will worsen the opioid epidemic and kill people needlessly", Dr. Sidney Wolfe, founder and senior adviser of Public Citizen's Health Research Group, said in a statement. Dsuvia was approved by the European Medicines Agency in June under the name Dzuveo. Leiman was a researcher on an AcelRx study of Dsuvia in post-surgical patients.

"We believe the unique features of Dsuvia are an important leap forward in the management of acute pain and patient care in these settings", AcelRx CEO Vince Angotti said in a statement.

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