Opioid 500 times stronger than morphine gets OK

Postado Novembro 07, 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 (FDA) approved a highly controversial opioid.

Democratic Senator Ed Markey of MA urged the FDA not to approve Dsuvia last month, saying "an opioid that is a thousand times more powerful than morphine is a thousand times more likely to be abused, and a thousand times more likely to kill".

Medical professionals administer Dsuvia underneath the tongues of patients with an applicator that releases the opioid in tablet form.

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".

The Food and Drug Administration (FDA) is getting the side-eye after approving a painkiller that's said to be 1,000 times stronger than morphine. "The military application for this new medicine was carefully considered in this case", Dr. Gottlieb said in a statement.

"It is certain that Dsuvia will worsen the opioid epidemic and kill people needlessly", Sidney Wolfe, founder of Public Citizen's Health Research Group, said in a statement. The opioid in question is a highly potent, and unsafe drug that has more risks than benefits in health-care.

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 numbers say it all: More people die in the United States each year from drug overdoses than from breast cancer.

Gottlieb said the drug will carry a boxed warning and won't be available at drugstores for patients to take home.

Drug overdose deaths hit the highest level ever recorded in the United States past year, with an estimated 200 people dying per day, according to a report by the U.S. Drug Enforcement Administration. This includes potential uses on the battlefield. 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".

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

AcelRx Pharmaceuticals, in a statement, said the drug was long in the making. Company executives said they expect to launch Dsuvia in the first quarter of 2019. Leiman was a researcher on an AcelRx study of Dsuvia in post-surgical patients.

The FDA has approved a new sublingual formulation of sufentanil, Dsuvia, for the management of acute pain in adults in medically supervised healthcare settings, such as hospitals, surgical centers, and emergency departments.