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Dsuvia – A new opioid with a high abuse potential hits the market

The Food and Drug Administration (FDA) approved “Dsuvia” – a new and extremely potent opioid – for management of acute pain in adults. This decision was made only a few weeks after the committee who reviewed the drug requested that the FDA reject its approval because the drug would likely be abused by users.

Dsuvia is a pill form of the opioid sufentanil, which has previously only been administered to patients intravenously or through an epidural. It is ten times more potent than fentanyl, an already controversial opioid responsible for the deaths of thousands of Canadians per year. Fentanyl is typically used in clinical settings but is also produced illegally.

Dsuvia was approved by the FDA review committee with a 10-3 vote. Despite that, Dr. Raeford Brown, the panel’s chairman, wrote a letter to the top FDA officials expressing his reluctance. Dr. Brown is an anesthesiology professor at the University of Kentucky and understands opioid pharmacology. He wrote that Dsuvia is “an extremely divertible drug,” and that he predicts “we will encounter diversion, abuse and death within the early months of its availability on the market.”

In response, Dr. Scott Gottlieb, the commissioner of the FDA released a statement to defend the panel’s decision. He stressed that Dsuvia will be delivered through a “pre-filled, single-dose applicator,” and that its use will only be permitted in clinical settings. Further, he noted that Dsuvia will only be idea for certain situations such as battlefield injuries in soldiers who do not have access to intravenous painkillers. Lastly, Dr. Gottlieb emphasized that Dsuvia will not be prescribed to patients for in-home use nor available at pharmacies. He wrote, “these measures to restrict the use of this product only within a supervised health care setting, and not for home use, are important steps to help prevent misuse and abuse.”

In addition to the safety measures put in place by the FDA, AcelRx, the company who creates the drug, will follow a risk evaluation and mitigation strategy put forward by the FDA. This includes monitoring distribution of the drug and data from wholesalers. Further, they will assess whether hospitals and health care providers are properly using drug; keeping an eye out for any diversion or abuse.

Last year, deaths caused by opioid overdose in the United States exceeded 40,000. More than 30,000 of these deaths were related to fentanyl. The FDA’s decision comes not long after states and the federal government have become more stringent on the prescription of opioids. In response, many patients living with chronic pain have complained about being undertreated or losing access to pain medication completely.

Dr. Brown was not present during the vote for Dsuvia’s approval. However, he cautions practitioners in his letter that Dsuvia is “so potent that abusers of this intravenous formulation often die when they inject the first dose.” In addition, he is skeptical that the FDA will successfully enforce its regulations when the drug hits the market. He wrote that in his experience with the FDA, once an opioid is approved, there are no safeguards to prevent the drug from reaching certain populations, nor are there any ongoing analyses of the risks that the drug poses to the general population.

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