FDA approves opioid stronger than fentanyl

FDA approves new opioid

The medication is called DSUVIA; it is a single-dose 30 mcg sublingual tablet of sufentanil. Approval of the drug was highly criticized; Raeford Brown, MD, chair of the FDA's Anesthetic and Analgesic Drug Products Committee, urged the FDA not to approve Dsuvia.

Drug overdose deaths hit the highest level ever recorded in the United States previous year, with an estimated 200 people dying per day, according to a report by the U.S. Drug Enforcement Administration.

The medication won't be available at pharmacies and shouldn't be used for more than 72 hours.

Brown, four U.S. Senators and the advocacy group Public Citizen have predicted that Dsuvia will be diverted to illicit use and cause more opioid overdose deaths. Drug overdose estimates from the Centers for Disease Control and Prevention hit record highs the past two years.

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Gottlieb said the drug will carry a boxed warning and won't be available at drugstores for patients to take home. The pill from AcelRx Pharmaceuticals contains the same decades-old painkiller often given in IV form or injection to surgical patients and women in labor. 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.

"Because of the risks of addiction, abuse and misuse with opioids; Dsuvia is also to be reserved for use in patients for whom alternative pain treatment options have not been tolerated, or are not expected to be tolerated, where existing treatment options have not provided adequate analgesia, or where these alternatives are not expected to provide adequate analgesia", according to a statement from Gottlieb about the drug's approval.

"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. The drug itself is only allowed for use in health-care settings and perhaps the battlefield and is not available to be sold separately at retail pharmacies. 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. "This drug just will work a lot more than morphine - it's 1,000 times stronger", she says. According to Gottlieb, "This opioid formulation, along with Dsuvia's unique delivery device, was a priority medical product for the Pentagon because it fills a specific and important, but limited, unmet medical need in treating our nation's soldiers on the battlefield".

In one study, the pill provided about the same pain relief to patients as IV morphine.

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