Experts question FDA’s approval of new opioid

By ISAAC CHEN | November 15, 2018

The opioid epidemic has become one of the greatest concerns in the U.S., with an estimated 29,000 deaths from overdose of fentanyl and other synthetic drugs last year, according to the Centers for Disease Control and Prevention. On average, 115 Americans pass away due to an opioid overdose every day. 

Despite the plethora of other opioids already available on the market, on Nov. 2 the Food and Drug Administration (FDA) approved a new opioid called Dsuvia produced by AcelRX Pharmaceuticals. Dsuvia is a 30 microgram sufentanil tablet administered under the tongue (sublingual) in a single-dose, pre-filled applicator. Previous studies have shown that sufentanil is 10 times for potent than fentanyl and 1,000 times more potent than morphine. 

Raeford Brown, chair of the FDA’s Anesthetic and Analgesic Drug Products Advisory Committee (AADPAC), was not present during the approval meeting due to previous commitments. However, he later wrote a statement expressing his opposition to the 10 to 3 vote on Oct. 12.

“It is so potent that abusers of this intravenous formulation often die when they inject the first dose,” Brown wrote in a letter to FDA leaders.

With four years of experience assessing countless opioids, Brown has observed that once the FDA approves a drug, there are no safeguards against the populations exposed to the drug or post-marketing assessment analyses of prescription behavior. There are also currently no regulatory policies that will guarantee that the drug will be used as described on the label. 

“Sublingual sufentanil represents a danger to the general public health and will make our job of protecting Americans more difficult,” Brown wrote. 

Brown also raised concern over whether there is a reason to put the health of the public at more risk by introducing another opioid in the market. 

Caleb Alexander, associate professor of Epidemiology and Medicine at the Bloomberg School of Public Health and co-director of the Center for Drug Safety and Effectiveness, also disapproves of the FDA’s decision to approve the opioid. Author of over 250 articles, his broad research interests include prescription drugs, regulatory policies and drug utilization. 

“There are dozens of rapidly acting opioids on the market, including highly potent products like sublingual fentanyl,” Alexander wrote in an email to The News-Letter. “It’s simply a stretch to argue that there is a large unmet need that outweighs the public health imperative of reigning in opioid overuses.” 

Therefore, experts argue that the potential value of Dsuvia does not outweigh the associated risks. 

“Unfortunately, this approval is yet another instance in which the FDA has interpreted its statutory obligations too narrowly, and I’m not sure why,” Alexander wrote. 

After the final approval, FDA Commissioner Scott Gottlieb addressed some of the concerns raised against the approval to defend the agency’s decision. Gottlieb wrote that during the approval process, the FDA takes into account the drug’s impact on the overall therapeutic options available to patients and providers. 

“We should consider whether we could do more in weighing approvals to ensure that new opioids are sufficiently better than existing drugs to justify their addition to the market in the context of the current crisis of abuse,” Gottlieb wrote in a statement. 

Furthermore, Gottlieb emphasizes that Dsuvia is restricted only to medically supervised health-care settings such as hospitals and emergency departments to control its distribution and use. It cannot be assessed simply through local retail pharmacies. Dsuvia also has important implications for soldiers on the battlefield, specifically in circumstances where patients cannot swallow oral medication. 

Besides the public health experts, four Democratic senators — Edward J. Markey of Mass., Richard Blumenthal of Conn., Claire McCaskill of Mo. and Joe Manchin of W.Va. — also wrote a letter to urge the FDA to deny the approval of Dsuvia. 

They questioned why the approval process went through the AADPAC without Brown, the chair, present and without the involvement of the FDA’s Drug Safety and Risk Management Advisory Committee. 

Alexander also explained the implications of the approval on the relationship between pharmaceutical companies and the FDA. 

“Its [Dsuvia’s] approval nevertheless signals to opioid manufacturers that things remain business as usual at the FDA — and that is the last thing we need when it comes to the opioid epidemic,” he wrote.

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