In an overwhelming 19-1 vote , the FDA joint advisory committee meeting held yesterday (4/22/2010) recommended that the FDA not approve Acura/King’s proposed oxycodone + niacin tablet. As we commented on Wednesday of this week, the sponsor’s data showed that about 16% of the intended patients would experience flushing at a normal dose of oxycodone. Yet, studies also show that the flushing can be almost totally negated by food or concomitant NSAIDs. Thus, abusers could easily – too easily in the judgment of the FDA panel – overcome the effects of niacin. FDA had previously issued a Complete Response Letter to Acura. This vote will seal the fate of the product concept.
This vote should not deter other companies from pursuing methods to prevent abuse. What it says is that you cannot cause harm (albeit, the flushing was mild with the chosen dose of niacin) to the intended patient in the process. I suspect that the Acura product without niacin would have been approved. Acura also used an excipient that caused irritation if the product was inhaled and another excipient that caused the product to gel, rendering it difficult to inject.