Last month, the Federal Drug Administration (FDA) approved a new opioid called Dsuvia that is 1000 times stronger than morphine and 10 times stronger than fentanyl. Despite being recommended by the FDA in a 10-3 vote, many have expressed concern about Dsuvia’s use. After hearing these concerns, Dr. Scott Gottleib, the FDA commissioner, released a statement that tried to mitigate concerns. His statement said that Dsuvia will only be administered by healthcare providers through a single dose applicator and will not be available for home use.
Despite Dr. Gottleib's statement, the approval of Dsuvia creates concerns beyond its own use. Recently, physicians have been encouraged to reduce their prescriptions of opioids. While prescription rates have decreased, the approval of Dsuvia sends the unintentional signal that we need to eliminate pain altogether.
The lack of consensus on opioid prescription rates is the result of historical ambiguity on opioid policies, and the approval of Dsuvia adds to this confusion. Prior to the 1990s, opioids were rarely used from chronic pain. However, during the 1990s, the medical environment changed and the treatment of pain became more flexible, leading to an expansion in opioid use. In 2001, however, policies shifted again and the Department of Veterans Affairs (VA) said that pain should be considered a “fifth vital sign” rather than a disease deserving treatment. Then, in 2008, researchers showed that short-term opioids are effective in treating severe pain, but evidence for long-term opioid treatment was fragmentary. Now, physicians are being encouraged to decrease their prescription rates and use alternative methods to address pain. Over the course of 30 years, various professional medical bodies sought to revise and clarify opioids guidelines, but this effort just led to confusion. The collapse of consensus around opioids resulted in prescribers setting their own practice patterns, creating prescription variation.
By approving Dsuvia, key constituents are sending the unintentional signal that pain should be eradicated altogether. This message contradicts the VA message that pain should be considered a “fifth vital sign” and the current movement to treat pain through alternative methods. While there are unintentional consequences of approving this drug, Dsuvia has only been approved for a month, so only time will tell how this new opioid will affect the landscape of the current epidemic.