Pharmaceutical

FDA approves potent new opioid despite public health concerns

opioid oxycodone Shutterstock 329x210 FDA approves potent new opioid despite public health concernsIn the midst of the nation’s opioid epidemic, the Food and Drug Administration (FDA) has approved a new, highly potent opioid for severe acute pain in adults that is five to 10 times more potent that fentanyl and 1,000 times stronger than morphine.

Dsuvia is a sublingual (under the tongue) formulation of sufentanil that is delivered to patients through a disposable, pre-filled, single dose applicator. Its use is restricted for certified medically supervised health care settings – such as hospitals, surgical centers and emergency departments for administration by a health care professional.

Dsuvia has some “unique features in that the drug is delivered in a stable form that makes it ideally suited for certain special circumstances where patients may not be able to swallow oral medication, and where access to intravenous pain relief is not possible,” the FDA said in a News Release.

This ability makes Dsuvia of particular interest in situations like on the battlefield, and for that reason the Department of Defense worked closely with the sponsor on development of this medication. “This opioid formulation, along with Dsuvia’s unique delivery device, was a priority medical product for the Pentagon because it fills a specific and important, but limited, unmet medical need in treating our nation’s soldiers on the battlefield,” the agency said.

The drug’s approval was met with criticism by nonprofit consumer advocacy group Public Citizen.

“It is certain that Dsuvia will worsen the opioid epidemic and kill people needlessly,” said Sidney Wolfe, MD, founder and senior advisor of Public Citizen’s Health Research Group. “It will be taken by medical personnel and others for whom it has not been prescribed. And many of those will overdose and die. It is likely, if not certain, that Dsuvia will be banned after ‘enough’ such deaths occur and the inevitable House oversight hearings are held investigating why the FDA approved this opioid with no unique benefit but unique harms.”

Sources:
Medscape
Public Citizen
FDA News Release