Senator Markey Urges FDA to Deny Approval of Powerful Opioid Dsuvia, Cites Warning of Committee Chair
Boston (October 18, 2018) – Senator Edward J. Markey (D-Mass.) today blasted the decision by a Food and Drug Administration (FDA) advisory committee to approve a powerful new opioid medication Dsuvia, an opioid painkiller that is up to 10 times more powerful than fentanyl and 1,000 times more powerful than morphine. This week, the FDA’s Anesthetic and Analgesic Drug Products Advisory Committee voted 10-3 to accept the application for approval of AcelRx Pharmaceuticals’ sublingual sufentanil medication. The advisory committee vote, however, occurred without the presence of its chair Dr. Raeford Brown, who has publicly opposed the application. The FDA also failed to have the full Drug Safety and Risk Management Advisory Committee participate in the Anesthetic and Analgesic Drug Products Advisory Committee meeting, thereby making approval of the application more likely. According to experts, the opioid sufentanil does not offer unique benefits over other available FDA-approved opioid products for treating serious pain and poses unique risks if it is misused or abused.
“An opioid that is a thousand times more powerful than morphine is a thousand times more likely to be abused, and a thousand times more likely to kill,” said Senator Markey. “Even in the midst of the worst drug crisis our nation has ever seen, the FDA once again is going out of its way to approve a new super-charged painkiller that would only worsen the opioid epidemic. It makes no sense to approve an opioid painkiller that has no benefits over similar medications and against the advice of experts. I call on the FDA to reject the vote of the advisory committee and stop the approval of this dangerously unnecessary opioid medication.”
The current deadline for FDA approval of the application is November 3, 2018.
Senator Markey has previously called for the FDA’s commitment to convene advisory committees for any future opioid-approval questions; to consider addiction, abuse and dependence as part of its determinations of which opioids are ‘safe’; and to rescind the approval of OxyContin for kids and convene an advisory panel to provide direction as it reconsiders that decision.