New Opioid Approved By FDA Is Stronger Than Fentanyl
The Food and Drug Administration has approved a new opioid to manage acute pain in adults. The drug is new form of a synthetic opioid called sufentanil that has historically been used intravenously and in epidurals. The drug will be marketed under the name Dsuvia by AcelRx. The drug is likely to hit the market early next year.
Dsuvia will be sold in tablet form and is delivered through a pre-filled, single-dose applicator. It will not be dispensed to patients for home use or be made available at retail pharmacies. It’s only approved for use in hospitals, surgical centers and other medically supervised settings. FDA commissioner Dr. Scott Gottlieb said in a statement, “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.”
The new drug’s approval has been met with some controversy. The country is in the midst of an opioid overdose epidemic that shows no sign of abating anytime soon. Opioid overdose deaths rose to more than 40,000 last year. More than 30,000 of those deaths were attributed to fentanyl and other synthetic opioids. Sufentanil is 10 times stronger than fentanyl.
Dr. Raeford Brown, the chairman of the advisory committee that reviewed the drug recommended rejection on grounds that it would likely be abused. In the letter he wrote to top FDA officials, he said, “I predict that we will encounter diversion, abuse and death within the early months of its availability on the market.” The advisory committee ultimately recommended that the agency approve the drug in a 10-3 vote.
Four Democratic senators – Richard Blumenthal of Connecticut, Edward Markey of Massachusetts, Claire McCaskill of Missouri and Joe Manchin of West Virginia – have also written a letter to FDA regulators criticizing the approval of the drug. States and the federal government have been cracking down on manufacturers and prescribers to reduce the supply of opioids available to consumers. The crackdown has led to many chronic pain patients complaining about being undertreated or completely losing access to opioids.