FDA to consider abuse-resistant oxycodone, Remoxy
King Pharmaceuticals Inc., in partnership with Pain Therapeutics Inc., has resubmitted its application to the Food and Drug Administration (FDA) for its painkiller Remoxy, touted by the manufacturer as being an abuse-resistant version of OxyContin. The FDA had previously delayed approval of the drug until it had more proof that Remoxy is less addictive.
Remoxy is a treatment for moderate to severe chronic pain and is intended to meet the needs of physicians who prescribe opioid painkillers and want to minimize risks of drug diversion, abuse or accidental patient misuse. The drug is used to treat pain by slowly releasing the narcotic oxycodone. It differs from OxyContin because the time-release mechanism on OxyContin can be disturbed if the drug is crushed or dissolved. Doing so allows users to get a high similar to heroin.
By contrast, Remoxy resists injection or snorting. Studies suggest that freezing, crushing or submerging the drug in high-proof alcohol for hours at a time releases just a fraction of oxycodone at time points when abusers presumably expect to get high.
King Pharmaceutical’s resubmitted application has a six-month review cycle.