Despite Warnings, FDA Approves Potent New Opioid Painkiller

The Food and Drug Administration has approved a potent new opioid painkiller, despite warnings from physician critics who say the drug will contribute to the addiction epidemic.

Dsuvia, a 3-millimeter-wide tablet of sufentanil made by AcelRx, came before an FDA advisory committee on Oct. 12. Such committees weigh in on the safety and efficacy of proposed products, and the FDA generally follows committee guidance in its decisions about drugs. The FDA’s Anesthetic and Analgesic Drug Products Advisory Committee voted 10-3 to recommend approval for the medication, and the agency approved the drug Friday.

“There are very tight restrictions being placed on the distribution and use of this product,” said FDA Commissioner Scott Gottlieb in a written statement Friday regarding his agency’s approval of Dsuvia. “We’ve learned much from the harmful impact that other oral opioid products can have in the context of the opioid crisis. We’ve applied those hard lessons as part of the steps we’re taking to address safety concerns for Dsuvia.”