FDA Staff Concerned About Additive Designed to Combat Pain Drug’s Abuse

Food and Drug Administration (FDA) staffers have questioned whether a proposed new drug that would add the B vitamin niacin to oxycodone in order to combat abuse would be effective and safe, Reuters reported April 20.

In a summary written for an FDA advisory panel that will issue a recommendation on the medication Acurox, staff with the federal agency stated that a study from one of the drug’s manufacturers found little deterrent effect on abuse from adding niacin to oxycodone. Manufacturers King Pharmaceuticals and Acura Pharmaceuticals have stated that adding niacin would discourage use of high doses of oxycodone because large amounts of niacin can cause uncomfortable flushing.

The FDA staff summary states that “while the oxycodone component in Acurox is efficacious, the agency has concerns about the use of niacin.” Staffers said the addition of niacin also appears to worsen the medication’s side effect profile, particularly with regard to flushing in pain patients.

Acura Pharmaceuticals has countered in its own summary for the FDA advisory panel that Acurox would limit misuse of oxycodone in numerous ways, including through ingredients that can cause burning in the nose if the medication is crushed and snorted. “It is not a perfect solution to the opioid abuse crisis, but it is a solution that warrants approval of the product,” states the Acura summary.