FDA Approves Opioid Drug 1,000 Times Stronger than Morphine

FDA OKs powerful opioid pill as alternative to IV painkiller

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. On October 12-so, not that long ago-AcelRx brought its sufentanil tablet Dsuvia before an FDA advisory committee. The FDA commissioner has also taken an unusual stance by saying that he wants more authority for the agency to consider similar drugs in the market which would make it easier for the agency to turn down applications for opioids in the future.

For Dsuvia specifically, Gottlieb referenced the opioid multiple times as a Pentagon priority, citing its potential use on the battlefield to treat soldiers through its sublingual formulation.

Dsuvia will not be available at retail pharmacies or for any home use, Gottlieb said.

It's 10 times more powerful than Fentanyl, making it 1,000 times more potent than morphine. "We are committed to the safe and effective administration of Dsuvia through diligent adherence to our FDA-approved Risk Evaluation and Mitigation Strategies program".

As the worst drug crisis in US history has accelerated, agency critics and some public officials have clamored for that holistic approach to narcotic painkillers, instead of the FDA's practice of evaluating each opioid application on its own.

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

USA regulators on Friday approved a fast-acting, super-potent opioid tablet as an alternative to IV painkillers used in hospitals. The medication, which comes in a single-use package, also should not be used for more than 72 hours.

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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 United States continues to struggle with the opioid abuse epidemic.

Scott Gottlieb was quick to defended the approval in a statement Friday: "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".

As for Dsuvia, even after approval, "the FDA will continue to carefully monitor the implementation of the [regulatory safeguards] associated with Dsuvia and compliance with its requirements, and we'll work to quickly make regulatory adjustments if problems arise", Gottlieb said.

He also stated he believes FDA approval for opioids should come "within a broad public health context", one that acknowledges other opioids on the market, alternative therapeutic options, the ongoing epidemic and the risk for further abuse.

Still, critics hold that the drug does not serve a unique need, despite its seemingly more controlled administration environment.

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