Ultra-Powerful Opioid Approved by FDA

Leslie Hanson
November 7, 2018

Leiman was a researcher on an AcelRx study of Dsuvia in post-surgical patients. However, the approval indicates the opioid is to only be used in certified medically supervised health care settings, such as hospitals, surgical centers, and emergency departments.

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

The drug is for very restricted use in operating rooms or on the battlefield.

"DSUVIA will not be available in retail pharmacies or for outpatient use". It is 10 times stronger than fentanyl, a parent drug that is often used in hospitals but is also produced illegally in forms that have caused tens of thousands of overdose deaths in recent years. The approval of Dsuvia was based on the results of 3 phase 3 clinical trials.

Sanjay Gupta that opioids are the biggest crisis facing the nation, a crisis fueled by overprescribing. Dsuvia was approved by the European Medicines Agency in June under the name Dzuveo.


"To that end, I've asked the professional staff at the FDA to evaluate a new framework for opioid analgesic approvals", he said. Dr. Raeford Brown, a professor of anesthesiology and pediatrics at the University of Kentucky, urged the FDA to reject the drug.

At the same time, 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. AcelRx Pharmaceticals, maker of the drug, explains that, in many care settings-including battlefield settings-patients may not have readily available access to intravenous (IV) treatments for pain, and intramuscular injections (currently the standard of care for battlefield patients) are not as effective as IV options at providing timely relief, and may not be effective in cases of severe trauma that involves hypovolemic shock.

"To what extent should we evaluate each opioid exclusively on its own merits, and to what extent should we also consider. the epidemic of opioid misuse and abuse that's gripping our nation?"

Dsuvia isn't created to be taken by people who haven't taken morphine in the past, Alan says. "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". Already, it's clear that in the context of the opioid crisis, "our evaluation of opioids is different than how we assess drugs in other therapeutic classes", Gottlieb noted. Dsuvia was a priority for the Pentagon because its unique properties make it suited for military use, which was a factor in the FDA's approval.

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

Other reports by Iphone Fresh

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