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AcelRx gets FDA nod for Dsuvia

AcelRx Pharmaceuticals has received the Food and Drug Administration’s blessing for Dsuvia.

Dsuvia is indicated for the management of acute pain in adults that is severe enough to require an opioid analgesic in certified medically supervised healthcare settings, such as hospitals, surgical centers, and emergency departments.

"The FDA approval of Dsuvia is the culmination of nearly 15 years of research to improve the standard of care for managing acute pain in medically supervised settings," AcelRx co-founder and chief medical officer Pamela Palmer said in a statement.

Dsuvia is a 30-mcg. sufentanil tablet in a single-dose, pre-filled applicator for under the tongue administration by a healthcare professional only in certified medically supervised settings.

"The approval of Dsuvia, which was developed in collaboration with the Department of Defense, underscores our commitment to provide innovative therapies for use in medically supervised settings," AcelRx CEO Vince Angotti said in a statement.

Dsuvia is expected to launch in the first quarter of 2019.
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