Published: Wed, November 07, 2018
Medical | By Vicki Mclaughlin

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

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

The Food and Drug Administration's approval of a powerful new opioid stirred up fierce opposition in some consumer and healthcare circles after it was announced Friday, continuing debate about the agency's role and responsibility in the opioid crisis. Each would come in a plastic applicator that looks like a syringe.

"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 Food and Drug Administration on Friday approved a new form of an extremely potent opioid to manage acute pain in adults, weeks after the chairman of the advisory committee that reviewed it asked the agency to reject it on grounds that it would likely be abused. Experts worry that supplies of the drug will somehow make their way from doctors' offices and pharmacies to addicts. "We are committed to the safe and effective administration of Dsuvia through diligent adherence to our FDA-approved Risk Evaluation and Mitigation Strategies program".

"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.

According to the FDA's statement, the drug was designed for military use, and while no one wants soldiers to suffer, some may argue that in the war against opioid-related overdoses, there are plenty of battlefields right here at home-with more than 115 people dying after overdosing on opioids every single day in the United States. "It will be taken by medical personnel and others for whom it has not been prescribed".

Brown added that he has personally tried to resuscitate health care providers who abuse sufentanil, "some successfully".

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The FDA says that controls on drugs inside medical facilities are tight and the greatest risk of diversion is among medical personnel themselves. Fewer than 1 percent of people said they acquired opioids that way. Advisors had warned that the opioid could be ill-used and would lead to more overdose deaths.

Along with the approval, Commissioner Scott Gottlieb released a statement of more than 2,200 words explaining the decision as well as how the agency will consider future opioid applicants.

Pamela Palmer, an anesthesiologist, said she founded the company to reduce the number of deaths caused by opioid dosing errors in hospitals and ambulatory care centers.

Emalie Gainey, a spokeswoman for state Attorney General Maura Healey, said Healey has "serious concerns" about Dsuvia and "will be monitoring this closely". It is only going to be used in medically-supervised settings, which [will not] contribute to the outpatient abuse issue.

Including brand name and generic drugs, there are almost 400 opioids now on the market.

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