FDA Approves Painkiller Dsuvia Amid Criticism

FDA Approves Painkiller Dsuvia Amid Criticism

Ruling against the recommendation of one of its chief experts, the U.S. Food and Drug Administration on Friday approved an extremely potent new opioid painkiller, Dsuvia.

Kolodny called Dsuvia an "exceptionally dangerous" drug that is 10 times stronger than fentanyl, which is 50 times stronger than heroin.

Dsuvia is a sublingual (meaning it is taken under the tongue) form of sufentanil (a synthetic opioid) that's delivered through a disposable, pre-filled, single-dose applicator, the FDA says. Dr. Gottlieb indicated the FDA will re-evaluate its consideration of individual and public health impacts of new approved opioids entering the market.

But Gottlieb stressed Friday that his agency has placed very tight restrictions on Dsuvia.

The medication should not be used for more than 72 hours at a time, according to the FDA. Advisors had warned that the opioid could be ill-used and would lead to more overdose deaths. 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. FDA has restricted its use to certified medically-supervised health care settings only, such as hospitals, surgical centers, and emergency departments, and for administration by a health care professional. According to the administration, prescription opioids were responsible for the most overdose deaths of any illicit drugs since 2001.

The chair of an FDA advisory panel that considered whether the drug should be approved, Dr. Raeford Brown, called it a "danger to the general public health" last month.

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

"It is certain that Dsuvia will worsen the opioid epidemic and kill people needlessly", said Dr. Sidney Wolfe, founder and senior adviser of Public Citizen's Health Research Group. 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. AcelRx returned to the committee this year, and on October 12 the drug was recommended for approval.

More: Drugs kill more Americans than guns, cars and AIDS.

In a statement, he said, "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". A spokeswoman said the company is not providing information on expected sales.

"The FDA approval of Dsuvia is the culmination of almost 15 years of research to improve the standard of care for managing acute pain in medically supervised settings", Palmer said in a statement.

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