FDA approves new opioid amid overdose concerns


The U.S. Food and Drug Administration today gave its approval to a new opioid drug, Dsuvia, for use in specific health care settings, amid concerns the new drug could contribute to additional overdose deaths if it makes its way into illegal markets.

Dsuvia is at least five times more potent than fentanyl, and is smaller in size.

Both aspects worry those fighting the nation’s opioid drug epidemic.

In a move that seemed to imply the FDA has heard and considered the concerns, FDA Commissioner Scott Gottlieb took the step of issuing a lengthy statement regarding Dsuvia and outlining steps the agency wants to take regarding the approval process for future opioid drugs.

Dsuvia, said Gottlieb, “has some unique features in that the drug is delivered in a stable form that makes it ideally 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. This includes potential uses on the battlefield.”

Gottlieb also said the FDA was taking a holistic approach with respect to approving future opioids. The strategy: Determine whether future opioids are improving on those already in the marketplace or whether they are simply adding to the existing opioid options.

You can read Gottlieb’s complete statement here.

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