Thursday, 22 November, 2018

US FDA Approves New-and Very Potent-Painkiller, Despite Warnings

FDA approves new opioid The FDA just approved an opioid painkiller 10 times more powerful than fentanyl
Melissa Porter | 07 November, 2018, 22:32

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 (FDA) is taking heat for approving a powerful, fast-acting opioid. It is 10 times stronger than fentanyl, a parent drug that is often used in hospitals but is also produced illegally in forms that have caused tens of thousands of overdose deaths in recent years. 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.

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. Critics point out that this comes amid an opioid epidemic in the United States - which led to more than 72,000 deaths in 2017 alone.

More: Drugs kill more Americans than guns, cars and AIDS. It would not be available in retail pharmacies.

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

"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.

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. For this reason, the Department of Defense (DoD) worked closely with the sponsor on the development of this new medicine.

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

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 manufacturer, a California company called AcelRx, will market the drug beginning in early 2019 under the name Dsuvia, at a wholesale price of $50 to $60 per dose. Dr. Palmer says that the drug will not be dispensed to patients via pharmacy; instead, it can only be administered by a healthcare provider in a medical center. On October 12-so, not that long ago-AcelRx brought its sufentanil tablet Dsuvia before an FDA advisory committee.