News outlets have decried the approval and emphasized sufentanil's effects as "500 times more powerful than morphine;" however, Pamela Palmer, MD, PhD, chief medical officer of AcelRx Pharmaceuticals, which developed the drug, explained in an interview with Pharmacy Times' sister publication, MD Magazine, that these overstatements are misguided.
The painkiller Dsuvia will be restricted to limited use only in health care settings, such as hospitals, surgery centers and emergency rooms, but critics worry the opioid will fuel an already grim opioid epidemic.
The FDA announced its approval November 2 of a new prescription opioid called Dsuvia, despite public and medical criticism for the drug's approval in the midst of the opioid epidemic, according to STAT.
At the same time, FDA Commissioner Scott Gottlieb issued an unusual statement saying he would seek more authority for the agency to consider whether there are too many similar drugs on the market.
"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.
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. 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. The guidelines would allow the agency to consider a narcotic's benefit to public health, its risk of being diverted for inappropriate use or abuse and its unique benefits to groups of people in pain before deciding to approve an opioid.
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"DSUVIA will not be available in retail pharmacies or for outpatient use".
Accordingly, then, the FDA's Anesthetic and Analgesic Drug Products Advisory Committee voted in favor, 10 to 3, of approval of this medication. The study demonstrated that patients receiving the drug experienced significantly greater pain reduction versus placebo over the first 12 hours post-treatment.
The drug, called Dsuvia, was approved Friday as a fast-acting alternative to intravenous painkillers.
Critics and public officials alike have commented on how the FDA should change its approach when evaluating opioid applications. Preliminary figures show more than 72,000 people died in 2017 from drug overdoses across the country.
And even as his agency gave the nod to Dsuvia, Gottlieb said other steps are being taken to restrict access to highly potent opioids.