FDA approves opioid painkiller 1000 times stronger than morphine

Lynette PayneNov 08, 2018

The opioid medication is a form of sufentanil, considered 5 to 10 times more powerful than fentanyl and 1000 times more potent than morphine.

The rate of overdose deaths among health care workers is relatively high, however, according to an August study by the Centers for Disease Control and Prevention, with 876 succumbing to prescription opioids between 2007 and 2012.

The U.S. Food and Drug Administration has approved the marketing of an opioid named Dsuvia, with FDA Commissioner Dr. Scott Gottlieb posting a lengthy statement defending the decision.

Supporters of the drug also argue that even though sufentanil is known to be very potent, the effective dose of Dsuvia is a tiny, premeasured 30 mcg. Alan says the concern around the drug is "valid given the potential for abuse". 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.

As the worst drug crisis in US history has accelerated, agency critics and some public officials have clamored for that holistic approach to narcotic painkillers, instead of the FDA's practice of evaluating each opioid application on its own.

Leading the dissent was Raeford Brown, the chairman of an FDA advisory committee that reviewed AcelRx Pharmaceuticals' Dsuvia last month and ultimately recommended its approval in a 10-3 vote. The Defense Department paid for R&D activities for Dsuvia through a 2015 contract in search for a replacement to using morphine injections, according to AcelRx's Securities and Exchange Commission filings.

The Food and Drug Administration is facing criticism over the approval of a drug called Dsuvia.

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. 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. Preliminary figures show more than 72,000 people died in 2017 from drug overdoses across the country.

The Redwood City, California-based company expects the pill to be available early next year at a price of $50 to $60 per pill.

"As a single-dose, non-invasive medication with a rapid reduction in pain intensity, DSUVIA represents an important alternative for healthcare providers to offer patients for acute pain management", Dr. David Leiman, clinical assistant of surgery at University of Texas at Houston, said in a statement from AcelRx.

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

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