FDA approves new opioid

Cheryl Sanders
November 8, 2018

Despite the ongoing opioid crisis plaguing the nation, the US Food and Drug Administration on Friday approved a new opioid medication five to 10 times more powerful than fentanyl.

This makes Dsuvia 1000 times stronger than morphine. The medication is called DSUVIA; it is a single-dose 30 mcg sublingual tablet of sufentanil.

"This new opioid will soon be hitting the market in the middle of the worst drug crisis this country has ever seen", the Bay State senator said. The tiny pill - just three millimeters in diameter - is likely to worsen the nation's drug crisis, according to critics and the head of the FDA's advisory committee on painkillers. It'll also help them evaluate the risk of a drug being misused or abused and also the unique benefits of the drug to the people in pain. Experts worry that supplies of the drug will somehow make their way from doctors' offices and pharmacies to addicts. 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. On Friday, new statistics released by the U.S. Drug Enforcement Administration found the number of opioid overdose deaths in the United States reached a new record previous year with 72,000 deaths - about 200 per day.

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While intravenous and epidural administrations of sufentanil have been FDA-approved for decades, Dsuvia's oral, under-the-tongue formulation was developed in collaboration with the Department of Defense. Dr. Raeford Brown, a professor of anesthesiology and pediatrics at the University of Kentucky, urged the FDA to reject the drug.

Sidney Wolfe of Public Citizen's Health Research Group, a consumer group, called Gottlieb's statement "empty rhetoric" and said the agency missed a big opportunity when it approved the pill. That panel recommended the drug's approval despite his warning. 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. And many of those will overdose and die. "That means it won't be available at retail pharmacies for patients to take home".

The Redwood City, California-based company expects the pill to be available early next year at a price of $50 to $60 per pill. Dsuvia is an unnecessary opioid, they say, and its size and potency will appeal to people looking to sell or misuse it.

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"We believe the unique features of Dsuvia are an important leap forward in the management of acute pain and patient care in these settings", AcelRx CEO Vince Angotti said in a statement.

"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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