ACRX - FDA reduces certain requirements under drug safety program for AcelRx's Dsuvia

AcelRx Pharmaceuticals (NASDAQ:ACRX) on Thursday said the U.S. Food and Drug Administration (FDA) had reduced certain requirements under the drug safety program required for the company's Dsuvia treatment for acute pain. ACRX's Dsuvia is indicated for use in adults only in a medically supervised or hospital setting for the management of acute pain severe enough to require an opioid analgesic and for which alternative treatments are inadequate. The tablet comes with a boxed warning for life-threatening respiratory depression and the potential to be abused and misused. The FDA had placed Dsuvia under a Risk Evaluation and Mitigation Strategy (REMS), which is a drug safety program that the FDA can require for certain medications with serious safety concerns. On Thursday, ACRX said the FDA in April had revised the Dsuvia REMS program to eliminate the six-month healthcare setting audit requirement and reduce annual healthcare setting audits to a total of up

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FDA reduces certain requirements under drug safety program for AcelRx's Dsuvia