FDA panel backs approval of Pfizer’s opioid painkiller

A U.S. advisory panel on Wednesday recommended approval of Pfizer Inc’s long-acting opioid painkiller Troxyca ER, saying it dulls pain and may deter people from snorting or injecting it.

The panel concluded that Troxyca ER is not likely to deter abuse by those seeking to manipulate and swallow it. Pfizer is seeking to market the drug as an abuse-deterrent product via all three routes.

On Tuesday the panel voted that a different type of long-acting opioid made by Teva Pharmaceutical Industries Ltd was likely to deter abuse whether addicts sought to swallow, snort or inject it.

Panelists were more conflicted about Pfizer’s drug, voting 9-6 to approve the product but voting 9-6 against the claim that it deters oral abuse. They voted 11-4 that the drug deterred nasal abuse and 9-6 that it deterred intravenous abuse.

“The committee is in a quandary about Troxyca ER,” Dr. Raeford Brown, Jr., a professor of anesthesiology and pediatrics at the University of Kentucky said, summarizing the views of the panel. “The data are not clear.”

The FDA is not obliged to follow the advice of its panels but typically does so.

(Reporting by Toni Clarke in Washington, editing by G Crosse)