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Amid deepening addiction crisis, FDA approves powerful new opioid

07 November 2018

Other news on opioids focuses on the FDA's armed hunt for counterfeit drugs and the continued threat of fentanyl and heroin.

The Food and Drug Administration approved a drug called Dsuvia Friday.

The product, Dsuvia, consists of the synthetic opioid sufentanil, which is 500 times stronger than morphine, packaged in a plastic applicator for faster pain relief.

Scott Gottlieb was quick to defended the approval in a statement Friday: "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". Dr. Gottlieb indicated the FDA will re-evaluate its consideration of individual and public health impacts of new approved opioids entering the market. Although the FDA has pledged to curb the on-going crisis, the statement made by the commissioner gives a clear insight as to how the agency will be moving forward with its drug evaluations.

"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. The opioid in question is a highly potent, and risky drug that has more risks than benefits in health-care. Preliminary figures show more than 72,000 people died in 2017 from drug overdoses across the country.

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USA regulators on Friday approved a fast-acting, super-potent opioid tablet as an alternative to IV painkillers used in hospitals. 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 tiny pill was developed as an option for patients who pose difficulties for the use of IVs, including soldiers on the battlefield. According to the administration, prescription opioids were responsible for the most overdose deaths of any illicit drugs since 2001. It notes that the Department of Defense was involved in its development and that it was a priority for the Pentagon because it "fills an unmet need". An estimated 51 million of these visits are to emergency departments (ED), with an estimated 18 million of these ED patients receiving an IV only for pain management.

Although the FDA is committed to reducing the opioid crisis and despite their claims to work in the interest of addiction-free drugs, the latest opioid may go against everything that has been said.

"I am very disappointed with the decision of the agency to approve Dsuvia". Alan says the concern around the drug is "valid given the potential for abuse".

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. On October 12-so, not that long ago-AcelRx brought its sufentanil tablet Dsuvia before an FDA advisory committee.

Amid deepening addiction crisis, FDA approves powerful new opioid