Pfizer opioid given mixed report after posing a ‘quandary’ for FDA panel

FDA

Pfizer ($PFE) has secured equivocal support for its long-acting opioid painkiller Troxyca ER from an FDA expert panel. The panel voted 9 to 6 in favor of approval of the drug, but a majority of the experts called for the FDA to reject a label claim regarding its ability to deter abuse when taken orally.

Only 6 of the panelists recommended the FDA grant Pfizer the oral abuse label claim. The experts were more amenable to Pfizer’s claims that the drug deters abuse via snorting or injection. Those claims were backed by votes of 11 to 4 and 9 to 6, respectively. The lack of overwhelming support for the drug in any of the votes--and the fact that one of the claims was rejected by a majority of the experts--is a reflection of the panel’s doubts about the data presented by Pfizer.

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

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Troxyca ER combines oxycodone with a drug intended to mute its abuse potential, a mix Pfizer had hoped would result in a potent painkiller that was free of some of the misuse issues that blight the sector. While some members of the FDA expert panel have reservations about the extent to which the data demonstrate Pfizer has achieved this goal, the Big Pharma has more faith in its results--and hopes the FDA will, too.

“Pfizer believes the ALO-02 data support approval with abuse-deterrent labeling and we look forward to ongoing discussions with the FDA,” Ken Verburg, chief development officer, neuroscience and pain at Pfizer, said in a statement.

With the panel having given its opinion on Troxyca ER and Teva’s ($TEVA) Vantrela ER--which received stronger, though still somewhat unenthusiastic, support from the committee--the focus now shifts to the FDA. Scrutiny of the decision, while unlikely to near Sarepta Therapeutics ($SRPT)-like intensity, may be higher than normal given the high profile of opioid abuse and the pressure members of Congress are applying to the FDA to take action.

- read Reutersreport
- and Pfizer’s release

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