FDA approves new, powerful drug amidst opioid crisis

FDA approves new opioid

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 Food and Drug Administration's approval of a powerful new opioid stirred up fierce opposition in some consumer and healthcare circles after it was announced Friday, continuing debate about the agency's role and responsibility in the opioid crisis. The drug is called Dsuvia, which is a tablet version of an opioid marketed for intravenous delivery, but is administered under the tongue using a specially developed, single-dose applicator.

"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. However, despite the warnings, the opioid has been approved by the FDA for use in health-care. These "unique features" make the medicine well-suited for the military and therefore was a priority for the Pentagon, a point that factored heavily into the decision, according to FDA Commissioner Scott Gottlieb. "It is certain that Dsuvia will worsen the opioid epidemic and kill people needlessly", Dr. Sidney Wolfe, founder and senior adviser of Public Citizen's Health Research Group, said in a statement. Part of that effort may be a closer and more stringent assessment of the need for new opioid formulations going forward, Gottlieb added.

The statement noted the benefit the drug could have for soldiers injured on the battlefield.

The sublingual administration makes Dsuvia an option for patients with nothing by mouth (NPO) status and patients with hard IV access (obese, elderly, burn or needle-phobic patients), according to the 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. The numbers say it all: More people die in the United States each year from drug overdoses than from breast cancer.

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

"I am very disappointed with the decision of the agency to approve Dsuvia". 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. Experts worry that supplies of the drug will somehow make their way from doctors' offices and pharmacies to addicts. It is expected to be available in the first quarter of next year.

The medication is called DSUVIA; it is a single-dose 30 mcg sublingual tablet of sufentanil. Dsuvia (sufentanil) will be marketed by California-based maker AcelRX.

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