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RoxyBond™ (oxycodone HCl immediate-release tablets) is now available for the management of pain severe enough to require an opioid analgesic and for which alternative treatments are inadequate.
RoxyBond is an abuse-deterrent formulation of immediate-release oxycodone. It features proprietary technology that includes inactive ingredients that make the tablets difficult to manipulate for misuse and abuse, even under physical manipulation and/or chemical extraction.
Compared with oxycodone immediate-release tablets, RoxyBond was found to have increased resistance to cutting, crushing, grinding, or breaking using selected tools. It also possesses physicochemical properties expected to make abuse via injection difficult and reduce abuse via the intranasal route.
The abuse potential of crushed intranasal RoxyBond 30 mg tablets was compared with crushed intranasal oxycodone immediate-release 30 mg tablets in a randomized, double-blind, placebo-controlled study involving 29 nondependent recreational opioid users with a history of intranasal drug abuse. Findings showed that RoxyBond was associated with statistically significantly lower “drug liking” and “take drug again” scores when compared with crushed intranasal oxycodone immediate-release tablets.
“With the launch of RoxyBond, we are now able to offer health care providers a treatment option that is expected to reduce abuse and misuse while providing their patients relief from pain,” said Dr Stefan Aigner, Chairman and CEO of Protega. “This combination of abuse-deterrent properties and clinical value for medically appropriate patients makes RoxyBond a reference of choice for prescribers and care givers.”
RoxyBond, a Schedule II controlled substance, is supplied as 5 mg, 15 mg, and 30 mg strength tablets in 100-count bottles.
References
- Protega Pharmaceuticals™ LLC announces commercialization of RoxyBond™ (oxycodone hydrochloride) tablets CII in the US. News release. Protega Pharmaceuticals LLC. Accessed July 6, 2022. https://www.globenewswire.com/news-release/2022/07/06/2474928/0/en/Protega-Pharmaceuticals-LLC-Announces-Commercialization-of-RoxyBond-oxycodone-hydrochloride-Tablets-CII-in-the-U-S.html
- RoxyBond. Package insert. Protega Pharmaceuticals LLC; 2022. Accessed July 6, 2022. https://dailymed.nlm.nih.gov/dailymed/fda/fdaDrugXsl.cfm?setid=72398542-8e0a-47b2-afeb-9ca5a1f15083&type=display
This article originally appeared on MPR
