FDA approves new, powerful drug amidst opioid crisis

FDA approves new, powerful drug amidst opioid crisis

FDA approves new, powerful drug amidst opioid crisis

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. Dsuvia (sufentanil) will be marketed by California-based maker AcelRX. In a statement, FDA Commissioner Scott Gottlieb, MD, sought to deflect criticism of the approval, saying that, "Looking beyond this particular drug approval, I believe that we should consider whether we should be doing more to evaluate each candidate opioid, not just as an independent review decision, but rather also to consider each novel opioid drug in the context of the overall therapeutic armamentarium that's available to patients and providers". This includes potential uses on the battlefield. 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.

Gottlieb said the drug will carry a boxed warning and won't be available at drugstores for patients to take home.

The decision has met a lot of criticism because the opioid is 5-10 times more potent than pharmaceutical fentanyl.

An FDA advisory committee did recommend for approval of Dsuvia in a 10-3 vote last month. Critics point out that this comes amid an opioid epidemic in the United States - which led to more than 72,000 deaths in 2017 alone.

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"The FDA has made it a high priority to make sure our soldiers have access to treatments that meet the unique needs of the battlefield, including when intravenous administration is not possible for the treatment of acute pain related to battlefield wounds".

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.

"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?" The goal, of course, was for the committee to determine the drug's overall safety and efficacy; and the FDA usually follows whatever guidance their committees provide.

Dsuvia isn't created to be taken by people who haven't taken morphine in the past, Alan says.

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"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.

The FDA has approved this new drug in the midst of a severe opioid epidemic in the country.

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

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