The Food and Drug Administration (FDA) approved a highly controversial opioid.
But critics of the drug and its potency - it's 10 times stronger than fentanyl - are tired that such a pill could add to the country's already alarming opioid epidemic.
Critics, including the head of the FDA advisory committee that reviews pain-relieving products, are anxious about putting such a potent and addictive medication on the market in the midst of the U.S.'s opioid crisis.
According to Gottlieb, there are very tight limitations for the use of the drug. It's intended for short-term use only, and should not be used for more than 72 hours.
Brown, four U.S. Senators and the advocacy group Public Citizen have predicted that Dsuvia will be diverted to illicit use and cause more opioid overdose deaths. "DSUVIA will only be distributed to health care settings certified in the DSUVIA Risk Evaluation and Mitigation Strategy (REMS) program following attestation by an authorized representative that the healthcare setting will comply with appropriate dispensing and use restrictions of DSUVIA", AcelRx said.
Gottlieb said the drug will carry a boxed warning and won't be available at drugstores for patients to take home. The military wants to explore whether the pill can be used as a battlefield painkiller that is less cumbersome than liquid analgesics.More news: Ariana Grande performs 'Thank U, Next' in a wedding dress
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. 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.
While intravenous and epidural administrations of sufentanil have been FDA-approved for decades, Dsuvia's oral, under-the-tongue formulation was developed in collaboration with the Department of Defense. Dsuvia was a priority for the Pentagon because its unique properties make it suited for military use, which was a factor in the FDA's approval.
The Redwood City, California-based company expects the pill to be available early next year at a price of $50 to $60 per pill. "This drug just will work a lot more than morphine - it's 1,000 times stronger", she says. 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.
"It's a huge mistake", Wolfe said.
"The FDA approval of Dsuvia is the culmination of almost 15 years of research to improve the standard of care for managing acute pain in medically supervised settings", Palmer said in a statement.