Government Relations Manager, National Research Center for Women & Families
April 22, 2010
Thank you for the opportunity to testify on behalf of the National Research Center for Women & Families.
Our Center is dedicated to improving the health and safety of adults and children, and we do that by scrutinizing medical and scientific research to determine what is known and not known about specific treatments and prevention strategies. We do not accept contributions from companies that make medical products.
Although Acura Pharmaceuticals should be applauded for trying to reduce the misuse and abuse of oxycondone, the key question is: can Acurox easily be abused? Unfortunately, the company has not proven that abuse is effectively deterred.
The flushing side effect caused by niacin is supposed to stop people from abusing the drug, but according to the company’s own data, patients tend to describe the flushing as moderately unpleasant, not intolerable. And that’s when they haven’t eaten or taken an aspirin or non-steroidal agent. If a person taking Acurox eats first, or takes aspirin, the drug would be even easier to abuse, because there would be even less flushing.
Even without eating or using aspirin or another pretreatment agent, the flushing associated with the use of niacin can lessen over time. The FDA scientists concluded that subjects appear to have developed tolerance to niacin within 10 days. And, as I just said, it would be easy enough to eat food or take aspirin at the same time and therefore avoid flushing.
Acura reformulated the drug to make it more difficult to melt or dissolve Acurox and to make it irritating to the nasal passages so people won’t snort it. Those are good strategies. But people could still abuse the drug by swallowing more of it, and the niacin is not proven effective to stop that abuse.
Given that the flushing is not very unpleasant and quite easy to avoid, it would be misleading to claim on the label or in advertisements that Acurox has been formulated to deter abuse – it’s too much of an overstatement. I can see the TV ads now: “Acurox is the safer way to take Oxycodone!” Overstating the deterrence could give doctors, patients, or family members a false sense of safety that this product would not be misused and abused. Acurox provides a small amount of deterrence — for people unwilling to eat or take aspirin — but labeling it as reducing the risk of abuse would result in very dangerous misconceptions that the drug is not abusable, when in fact it can easily be abused. Overdoses would be simple to accomplish.
Thank you for the opportunity to speak today. We think the company’s research is inadequate to prove their drug can’t easily be abused, and in fact, we believe it can be easily abused through ingestion. Remember that the FDA does not need to prove that the drug does NOT deter abuse. It is the company that needs to prove that this drug would deter abuse. They have not done so.