Amid Deepening Addiction Crisis, FDA Approves Powerful New Opioid Dsuvia
Nov 08 2018
Experts and elected officials are lambasting the Food and Drug Administration for approving a new opioid that is 500 times stronger than heroin as the nation is in the grip of an addiction crisis.
The drug is called Dsuvia, and FDA commissioner Scott Gottlieb, MD, addressed the timing in a statement released late last week. "The crisis of opioid addiction is an issue of great concern for our nation", he said.
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. Advisors had warned that the opioid could be ill-used and would lead to more overdose deaths. Drug overdose estimates from the Centers for Disease Control and Prevention hit record highs the past two years.
One factor that weighed heavily in the Dsuvia decision is military interest in the drug, Gottlieb said in his statement. FDA has restricted its use to certified medically-supervised health care settings only, such as hospitals, surgical centers, and emergency departments, and for administration by a health care professional. The FDA commissioner has also taken an unusual stance by saying that he wants more authority for the agency to consider similar drugs in the market which would make it easier for the agency to turn down applications for opioids in the future.
The drug, called Dsuvia, was approved Friday as a fast-acting alternative to intravenous painkillers.
The FDA also said it had signed a memorandum of understanding with the Defense Department to expedite availability of medical products, particularly those used to treat injuries in battlefield settings. Dr. Raeford Brown, a professor of anesthesiology and pediatrics at the University of Kentucky, urged the FDA to reject the drug.
"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. Preliminary figures show more than 72,000 people died in 2017 from drug overdoses across the country. Already, it's clear that in the context of the opioid crisis, "our evaluation of opioids is different than how we assess drugs in other therapeutic classes", Gottlieb noted. A spokeswoman said the company is not providing information on expected sales.
An FDA advisory committee did recommend for approval of Dsuvia in a 10-3 vote last month. As such, "We believe the unique features of Dsuvia are an important leap forward in the management of acute pain and patient care in these settings", said AcelRx's CEO, Vince Angotti, in a statement. Dsuvia is an unnecessary opioid, they say, and its size and potency will appeal to people looking to sell or misuse it.