The Atlanta Journal-Constitution
Powerful new opioid could get FDA approval
Review panel head comes out against post-surgery drug.
WASHINGTON — The Food and Drug Administration is poised to approve a new form of a powerful opioid for use in hospitals and emergency rooms despite opposition from the head of the committee that reviewed the drug.
The FDA is scheduled to decide by Nov. 3 whether to allow a California company to produce a 30-microgram pill form of sufentanil, a potent painkiller commonly used after surgery.
An FDA advisory committee recommended approval of the drug in a 10-to-3 vote on Oct. 12. The FDA usually follows the guidance of those committees, which are comprised of experts on various drugs and medical devices.
But in this case, the chairman of the committee, who missed the meeting because he was speaking at a medical conference in San Fran- cisco that day, has publicly urged the agency to reject the drug application because of the epidemic of opioid over- doses in the United States.
Raeford Brown, a profes- sor of anesthesiology and pediatrics at the University of Kentucky who heads the FDA’s Anesthetic and Analgesic Drug Products Advisory Committee, sent his views in a letter to FDA Commissioner Scott Gottlieb and other agency officials. He also made his opposition public, a rare step for an FDA advisory committee chairman.
Brown said another potent painkiller is not needed in medical centers. The drug is five to 10 times more potent than pharmaceutical fentanyl. The tiny pill — just three millimeters in diam- eter — is all but certain to be diverted to the streets, he said. Brown also said the safety and effectiveness of the new drug has not been fully proven.
Sen. Edward Markey, D-Mass., and the advocacy group Public Citizen, which co-signed Brown’s letter to Gottlieb, also oppose FDA approval of the drug, which the company AcelRx would market as Dsuvia.
“This is a drug which is being proposed for approval at a time when we are trying to get the issues of opi- oid misuse and abuse under control in the United States,” Brown said in an interview. “We have yet [to] be effective at preventing diversion of these opioids, and we try very hard.”
In July, Gottlieb issued a statement promising that the FDA would balance efforts to curb the drug crisis with the needs of patients in pain.
“The FDA remains focused on striking the right balance between reducing the rate of new-addiction by decreasing exposure to opioids and rationalizing prescribing, while still enabling appropriate access to those patients who have legitimate medical need for these medicines,” he said.
Hundreds of millions of doses of prescription painkillers have been diverted from the pharmaceutical supply chain to illegal users over the past 15 years, during what has become the worst drug crisis in U.S. history. In many cases, illicit users obtain them from friends, relatives or rogue doctors and pharmacists, according to a 2016 survey conducted by the federal Substance Abuse and Mental Health Services Administration. A significant portion were stolen from health-care providers, according to the survey.