Courtesy of Bloomberg

FDA declines to approve Mallinckrodt’s abuse-deterrent opioid painkiller



The U.S. Food and Drug Administration opted not to approve an abuse-deterrent version of Mallinckrodt’s opioid painkiller, Roxicodone.

The reformulated version of the drug was designed to make it more difficult to abuse by snorting or injecting.

The rejection follows after an FDA advisory panel voted 10-7 to recommend the drug. However, the panel said the drug should only be labelled as abuse-deterrent if administered nasally.

Mallinckrodt’s share price slid after the Wednesday announcement, falling 8.2 percent between the close of trading Tuesday and the final bell Friday.

Mallinckrodt, which has its U.S. headquarters in St. Louis, is one of the largest manufacturers of oxycodone, one of the most commonly abused prescription painkillers.

Read more: St. Louis Post Dispatch

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