On Friday, the United States Food and Drug Administration (FDA) approved a new opioid despite strong opposition to the new drug. The military asked that the FDA approve the drug.
According to an NBC News report, the FDA approved a powerful new drug, Dsuvia, amidst strong criticism that the governing body did not follow its own process during the approval. The drug, called sufentanil generically, goes under the tongue to treat intense, acute pain, and it was designed to use in battlefields and emergencies. It is ten times more powerful than fentanyl and 1,000 times more potent than morphine, and some healthcare providers feel significant concern.
AcelRx makes the 3-millimeter-wide tablet. The drug cannot be used for more than 72 hours and must be administered by a health care provider. Plus, it cannot be used at home.
On October 12, the new drug went in front of the FDA panel, which voted 10-3 on Friday to recommend approval of the potent opioid, NPR reported.
At a time when many states are limiting opioid distribution and cracking down on misuse, the approval strikes some experts as a bad move.”This is a dangerous, reckless move,” said Dr. Sidney Wolfe, senior adviser of Public Citizen’s Health Research Group, which was left out of the entire process. Because of the concentrated nature and small size of the drug, its detractors believe that the FDA’s decision puts people in danger because it would be easy to divert into the black market.
Others, like Dr. Pamela Palmer, an anesthesiologist and co-founder of AcelRx, feel that the fact that pharmacies don’t dispense the drugs for patients to take home will end up helping prevent misuse. “It will not contribute to the large outpatient opioid crisis,” said Palmer.
The FDA just approved an addictive opioid that is five to 10 times more potent than fentanyl and 1,000 times more potent than morphine. This is absolutely the wrong call. Dsuvia will worsen the opioid epidemic and kill people needlessly. https://t.co/xoYmT251We
— Public Citizen (@Public_Citizen) November 2, 2018
However, in a statement, FDA Commissioner Dr. Scott Gottlieb defended the decision. He wrote, “We understand the concerns about the availability of a high potency formulation of sufentanil and the associated risks. There are very tight restrictions being placed on the distribution and use of this product. We’ve learned much from the harmful impact that other oral opioid products can have in the context of the opioid crisis.”
Dr. Raeford Brown, chair of the FDA’s Anesthetic and Analgesic Drug Products Advisory Committee and a professor of anesthesiology and pediatrics at the University of Kentucky, wrote in a statement, “I am very disappointed with the decision of the agency to approve Dsuvia.”
Brown went on to point out that he believes the drug’s approval is inconsistent with the FDA’s charter. Brown reported that the sponsor did not properly answer safety concerns or provide sufficient efficacy data.
Opioids and heroine have killed between 40,000 and 50,000 people a year since 2016.