WASHINGTON- The nytimes.com reports that a new and highly potent form of opioids has been approved by the Food and Drug Administration (FDA) as a treatment for acute pain despite a review from the advisory committee that found there was a high risk of the drug being abused.
The drug is named Dsuvia, and it is a form of a synthetic opioid called sufentanil, which has been in use since the 1980s. Previous forms of the drug were intravenous and in epidurals, but the new form comes in a tablet. Dsuvia is “10 times stronger than fentanyl,” which is a synthetic opioid used by hospitals, but that has also been illegally produced and has led to an increase in drug overdoses across the United States.
The FDA advisory committee recommended 10-3 to approve Dsuvia, but the chairman of the panel, Dr. Raeford Brown, wrote to the FDA and stating that he was deeply concerned about the drug being abused. Dr. Brown stated that the drug was “extremely divertible” and that he predicts that the drug will be diverted, leading to abuse and overdose deaths after being on the market for only a matter of months.
In his defense of the agency’s decision, the FDA commissioner, Dr. Scott Gottlieb, wrote that the drug is only administered in medical centers and will not be available for patients to use at home. Dsuvia will not be for sale in retail pharmacies and will only be offered in single-dose applicators that will be administered by healthcare providers.
The controversy over the new drug comes after the total number of fatal opioid deaths rose to a record of over 40,000 in 2017. Synthetic opioids like fentanyl were responsible for greater than 30,000 of those deaths.
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