FDA approves new dose for abuse-deterrent oxycodone

The FDA approved RoxyBond 10 mg immediate-release tablet for the management of pain requiring an opioid analgesic for which there are no adequate alternative treatments, according to a press release from the manufacturer.

Previously approved for 5, 15 and 30 mg immediate-release formulations, this additional indication for oxycodone hydrochloride (RoxyBond, Protega Pharmaceuticals) is the first 10 mg abuse-deterrent immediate-release oxycodone formulation approved by the FDA, Protega said in the release.

The agent uses the proprietary SentryBond abuse-deterrent technology.

“It is designed to provide multiple levels of protection that resist physical manipulation, chemical extraction, and manipulation or transformation for injection,” according to the release. “Protega's proprietary SentryBond technology platform could potentially be utilized in other medications to help deter misuse and abuse .... While these uses are currently not available and require FDA approval, the technology can help in a variety of medications.”

Testing has shown that RoxyBond has higher resistance to cutting, crushing, grinding or breaking, as well as passage through a needle, in addition to greater resistance to extraction using selected household and laboratory solvents, the release stated. However, it is still possible for abuse to occur via the intranasal, oral and IV route, it added.

"The development of RoxyBond with SentryBond is a step forward in fighting the national epidemic of prescription opioid overdose," Eric Kinzler, PhD, vice president of medical and regulatory affairs for Protegam said in the release. "Protega is dedicated to our mission to block the path to abuse and work with healthcare professionals across the continuum of care to reduce misuse and abuse. We look forward to responsibly launching RoxyBond 10 mg and advancing our innovative technology platform for potential application in other commonly abused prescription medications."