FDA Modifies Dsuvia REMS Program

The FDA has recently modified the Dsuvia Risk Evaluation and Mitigation Strategies (REMS), eliminating the six-month healthcare setting audit requirement and reducing annual healthcare setting audits. Previously the FDA required the manufacturer, AcelRx Pharmaceuticals, to audit all healthcare settings within six months of an initial order, and to then continue to audit all such sites annually thereafter.

The FDA approved Dsuvia (sufentanil), a synthetic opioid, in November 2018 for the management of acute pain severe enough to require an opioid analgesic. It is a sublingual tablet that was designed to provide rapid pain relief and to eliminate dosing errors associated with intravenous administration.

Dsuvia was approved with a REMS program to ensure proper use and administration. The REMS required distribution through certified healthcare settings and required AcelRx to audit these facilities.

“We continue to work closely with the FDA on the Dsuvia REMS program and have established a track record of compliance and safety, including lack of accidental exposure,” Pamela Palmer, M.D., Ph.D., co-founder and chief medical officer of AcelRx, said in a press release. “We believe that it is this history of stewardship and responsibility, which is included in our latest three-year assessment REMS report as submitted to the FDA, that has resulted in the lowering of both the number and frequency of required site audits.”

In February 2021, the FDA had issued a warning letter to AcelRx about false and misleading advertising. The company’s “Tongue and Done” campaign, the agency said, minimized the risk of serious adverse events and undermined the conditions for safe use. The company in a 2021 earnings release said that it been notified by the FDA that AcelRx had met all requirements of the warning letter.