- The FDA has recently modified the AcelRx Pharmaceuticals Inc's (NASDAQ:ACRX) Dsuvia Risk Evaluation and Mitigation Strategies (REMS) requirements for healthcare setting audits.
- The Dsuvia REMS program aims to mitigate the risk of respiratory depression resulting from accidental exposure by ensuring that DSUVIA is dispensed only to patients in certified medically supervised healthcare settings.
- In April, the FDA revised the Dsuvia REMS program to eliminate the 6-month healthcare setting audit requirement and reduce annual healthcare setting audits to up to 400 sites that have received a shipment of Dsuvia in the past six months.
- Previously, the DSUVIA REMS required AcelRx to audit all healthcare settings within six months of an initial Dsuvia order and continue to audit all such sites annually after that.
- Dsuvia, known as Dzuveo in Europe, is indicated for pain management in certified medically supervised healthcare settings.
- Price Action: ACRX shares are up 18.10% at $0.27 during the market session on the last check Thursday.
