Acura Pharmaceuticals and King Pharmaceuticals were handed a widely expected FDA expert panel rejection yesterday for their pain drug Acurox. In a 19 to 1 vote, the committee determined that the drug's anti-abuse properties weren't strong enough to warrant approval. In addition to properties that prevent the drug from being abused, Acura and King added niacin to Acurox, which causes uncomfortable flushing if too many pills are taken. But niacin's effects can be dulled by taking the pills with food, leading panelists to question whether it truly is an effective abuse deterrent.
"What I'm hearing from the committee is that it's probably not appropriate to put the niacin in this product because it does not have a definitive advantage, and it has associated side effects," said Jeffrey Kirsch, chairman of the Anesthetic and Life Support Drugs Advisory Committee, which voted on the drug.
In a statement, Acura and King said only that addition of niacin to Acurox was central to the deliberations, and that the companies will work with the FDA to determine the next steps for the Acurox development program. The FDA doesn't have to follow the expert panel's recommendations, but it usually does.
- see Acura's release
- here's the Bloomberg report