FDA Modifies REMS Requirements for Opioid Analgesic Dsuvia

The Risk Evaluation and Mitigation Strategies (REMS) requirements for Dsuvia® (sufentanil) have recently been modified by the Food and Drug Administration (FDA) with regard to health care setting audits.

The goal of the Dsuvia REMS is to mitigate the risk of respiratory depression resulting from accidental exposure by ensuring that Dsuvia is dispensed only to patients in certified medically supervised health care settings.

Dsuvia contains sufentanil, an opioid agonist, and is classified as a Schedule II controlled substance. The product is indicated for use in adults in a certified medically supervised health care setting, such as hospitals, surgical centers, and emergency departments, for the management of acute pain severe enough to require an opioid analgesic and for which alternative treatments are inadequate. It is intended for sublingual delivery only by a health care provider.

The revised Dsuvia REMS program eliminates the need for AcelRx to audit all health care settings within 6 months of an initial Dsuvia order and reduces annual health care setting audits to a total of up to 400 sites that have received a shipment of Dsuvia in the past 6 months. Previously, AcelRx was required to audit all sites within 6 months of an initial order, and then continue annual audits with no limit to the number of sites audited.

“We continue to work closely with the FDA on the Dsuvia REMS program and have established a track record of compliance and safety with Dsuvia, including lack of accidental exposure,” said Pamela Palmer, MD, PhD, Co-Founder and Chief Medical Officer of AcelRx. “We believe that it is this history of stewardship and responsibility, which is included in our latest 3-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.”

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