FDA advisers side against Purdue's new painkiller, citing dosing dangers

A panel of FDA advisers voted against approving the latest pain treatment from Purdue Pharma, worried that quirks in the pill's dosing could put patients at risk.

The agency's independent analgesics committee voted 23-1 against recommending Purdue's Avridi, a formulation of the opioid oxycodone designed to be harder to abuse than painkillers past. Panelists worried about the drug's relationship with food: Avridi, an immediate-release painkiller, is meant to be taken every four to 6 hours on an empty stomach for maximum efficacy.

But patients may find it difficult to stick to such a strict window, panelists said, leading them to take the drug with and without food and put themselves at risk for dangerous variability in dosing. Furthermore, full-stomached patients may choose to take more Avridi to counteract its dulled effects, increasing the odds of overdose, the committee said.

The panel's negative take on Avridi echoes concerns presented by FDA staff earlier this week, and both groups agreed that Purdue's proposed drug label would be unlikely to deter misdosing were it approved.

The FDA is not required to follow the votes of its advisory committees, though it most commonly does. Purdue has not disclosed when it expects the agency to hand down a final decision on Avridi, but the FDA generally acts within a two months of its panel meetings.

Avridi's negative recommendation comes on the heels of Purdue's regulatory retreat with another oxycodone treatment. In July, the company pulled out of a meeting with the same panel just days ahead of the vote, withdrawing its application for an abuse-deterrent form of OxyContin and citing "the complexity of epidemiological research and the unprecedented nature of this exercise" in doing so. Purdue said it plans to complete "additional analyses" before resubmitting the drug but has not provided a timeline for doing so.

- read the FDA briefing (PDF)

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