In 19-1 vote, FDA panel rejects Acurox

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...

Acura shares slide on stinging FDA staff review of Acurox

Shares of Acura Pharmaceuticals (NASDAQ: ACUR) tumbled 21 percent after staffers at the FDA questioned whether its pain drug, Acurox, was actually designed to deter abuse or simply negatively affected the adverse event profile of the therapy. In a stinging review, regulators questioned Acura's combination of oxycodone and niacin, a B vitamin that can trigger discomforting flushing in patients at high doses. "Niacin offers little in the way of deterrence to oral abuse," wrote staffers, raising...