U.S. FDA Approves AcelRx Pharma`s Opioid Pain Drug

By Reuters Staff

(Reuters) - The U.S. Food and Drug Administration on Friday approved AcelRx Pharmaceuticals Inc's opioid-based fast-acting treatment for pain to be used under medical supervision.

"The medicine is restricted to use in certified medically-supervised health care settings ‒ such as hospitals, surgical centers and emergency departments ‒ for administration by a health care professional," FDA Commissioner Scott Gottlieb said in a statement.

The approval comes a year after the initial marketing application for the drug, Dsuvia, was rejected by the agency, which sought additional safety data and certain changes to ensure that the drug was administered properly.

An FDA panel in October voted 10-3 in favor of Dsuvia's approval after the company reworked its application by halving the maximum dosage to 12 pills a day, and making certain changes to the directions of use.

Dsuvia is a sublingual pill form of the common injectable opioid sufentanil and is delivered through a pre-filled applicator.

Dsuvia has some unique features where the drug is delivered in a form that makes it suited for certain special circumstances where patients may not be able to swallow oral medication, and where access to intravenous pain relief is not possible, Gottlieb said.

"This includes potential uses on the battlefield. For this reason, the Department of Defense worked closely with the sponsor on the development of this new medicine," the FDA chief said.

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