Critics blasted the agency for bringing a new opioid to market as the nation faces increasing opioid overdose deaths in what many call a crisis.
Critics are blasting the FDA for approving Dsuvia as the country faces increasing opioid overdose deaths.
But Gottlieb stressed Friday that his agency has placed very tight restrictions on Dsuvia. "It is certain that Dsuvia will worsen the opioid epidemic and kill people needlessly", Dr. Sidney Wolfe, founder and senior adviser of Public Citizen's Health Research Group, said in a statement.
More: The opioid crisis hits home. It will not be available at your local pharmacy and is designed only for use in a "certified medically-supervised healthcare settings".
"Because of the risks of addiction, abuse and misuse with opioids; Dsuvia is also to be reserved for use in patients for whom alternative pain treatment options have not been tolerated, or are not expected to be tolerated, where existing treatment options have not provided adequate analgesia, or where these alternatives are not expected to provide adequate analgesia", according to a statement from Gottlieb about the drug's approval.
Gottlieb also points out in his statement that it can help in special circumstances in which a patient may not be able to swallow, adding that there could be potential uses on the battlefield.
The pills contain sufentanil, a chemical cousin of the opioid fentanyl. But Raeford Brown, a professor of anesthesiology and pediatrics at the University of Kentucky who chairs the committee, then took the rare step of publicly condemning that decision and urging the FDA to reject the drug.
AcelRx already has approval for 15- and 30-microgram versions of the drug in Europe.
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. The Defense Department paid for R&D activities for Dsuvia through a 2015 contract in search for a replacement to using morphine injections, according to AcelRx's Securities and Exchange Commission filings.
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