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FDA approves new opioid analgesic - Dsuvia™ (sufentanil sublingual tablet)

by
Optum Workers' Comp
| Nov 06, 2018

On November 2, 2018, the U.S. Food and Drug Administration (FDA) approved the first and only sufentanil sublingual (under-the-tongue) tablet for acute pain in healthcare settings, Dsuvia (sufentanil sublingual tablet, 30 mcg). Dsuvia contains a small sufentanil tablet in a disposable, pre-filled, single-dose applicator that can be placed under the tongue.

According to the manufacturer, AcelRx Pharmaceuticals, Inc., Dsuvia has been developed for the management of moderate-to-severe acute pain in a variety of medically-supervised settings. Situations where this medication may be used include in emergency medicine, for outpatient or ambulatory surgery, with non-surgical patients experiencing pain in the hospital, or in post-operative patients following short-stay surgery not requiring long-term analgesia. As such, it should not be used for more than 72 hours and may be helpful in situations where patients are unable to swallow oral medications.

Dsuvia will not be available in retail pharmacies or for home use. AcelRx states that the distribution of this medication would be limited to certified medical institutions as it must be administered by healthcare professionals only. Like all opioid analgesics, Dsuvia will have a Risk Evaluation and Mitigation Strategy (REMS) program in place to help ensure informed and safe use. Sufentanil, a schedule II controlled substance, is much more potent than fentanyl and morphine and thus should be used with extreme care.

This formulation has already been approved for use in Europe under the name Dzuveo™; however, the company is expected to launch, Dsuvia, in the U.S. in the first quarter of 2019. The cost of the medication has not yet been published. Prior to a full review and evaluation by our Pharmacy and Therapeutics Committee, at a minimum, Dsuvia will require prior authorization on all of our standard formularies.

For more insight on the approval of Dsuvia from the FDA Commissioner, Scott Gottlieb, M.D., click here.

If you have any questions, please contact your account manager, clinical liaison or our Clinical Services team at 1-877-275-7674 ext. 8612.

Sources:

  1. U.S. Food and Drug Administration Advisory Committee Briefing Document. AcelRx Pharmaceuticals, Inc. DSUVIA™ (sufentanil) sublingual tablet, 30 mcg. October 12, 2018. Available at https://www.fda.gov/downloads/AdvisoryCommittees/CommitteesMeetingMaterials/Drugs/AnestheticAndAnalgesicDrugProductsAdvisoryCommittee/UCM622858.pdf.. Accessed October 22, 2018
  2. AcelRx Pharmaceuticals, Inc. November 2, 2018. AcelRx announces FDA approval of DSUVIA™ [Press release]. Available at: http://ir.acelrx.com/news-releases/news-release-details/acelrx-announces-fda-approval-dsuviatm. Accessed November 5, 2018
  3. AcelRx Pharmaceuticals, Inc. Dsuvia™ (sufentanil) sublingual tablet 30 mcg. Available at: http://www.dsuvia.com/.. Accessed November 5, 2018


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