FDA Approves Potent New Opioid Sulfentanil Despite Abuse Warnings

Yesterday, the Food and Drug Administration (FDA) approved the drug Dsuvia (Sulfentanil – sublingual 30mcg tablet), a potent synthetic opioid, for the management of acute pain severe enough to require an opioid analgesic for adult patients in certified medically supervised healthcare settings such as hospitals, surgical centers and emergency departments.

Intravenous Sulfentanil has been used intravenously and in epidurals for over 30 years, but Dsuvia is available only in a tablet form. Dsuvia is ten time stronger than fentanyl, its parent drug that is most commonly used in hospitals, but, in recent years, it has been produced illegally and is associated with thousands of death.

Dsuvia will be available in a single-dose, pre-filled applicator for sublingual (under the tongue) administration by a healthcare professional.

Critics of the FDA’s decision fear it will be east for healthcare workers to divert the drug to the black market, in part because it is so small and openly question why there is a need for another synthetic opioid while the US is in the midst of an opioid overdose crisis.

FDA Commissioner Dr. Scott Gottlieb, however, has noted that there will be very tight restrictions placed on the distribution and use of Dsuvia.