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A new abuse-deterrent painkiller - oxycodone hydrochloride (RoxyBond, Inspirion Delivery Services) - will be available soon after receiving FDA approval.
A new abuse-deterrent painkiller-oxycodone hydrochloride (RoxyBond, Inspirion Delivery Services)–will be available soon after receiving FDA approval.
RoxyBond, approved in 5 mg, 15 mg and 30 mg strengths, is an abuse-deterrent formulation of oxycodone that uses physical and chemical barriers to deter abuse, without the use of aversive agents or opioid antagonists. According to Inspirion, RoxyBond is the first immediate-release opioid analgesic approved with labeling describing its abuse-deterrent properties.
Last August, FDA also approved Pfizer’s oxycodone/naltrexone (Troxyca ER) extended-release, abuse-deterrent oxycodone. Troxyca ER has properties that are expected to reduce abuse when crushed and administered by the oral and intranasal routes, according to Pfizer.
“Oxycodone immediate release opioid tablets are widely abused and the development of RoxyBond will offer clinicians a new approach for treating patients in pain while also fighting against the potential for abuse,” said Jeffrey Gudin, MD, department director of the Pain Management Center Englewood Hospital and Medical Center, in a statement from Inspirion.
Using Inspirion's SentryBond technology, Roxybond is formulated with inactive ingredients that make the tablet more difficult to manipulate for misuse and abuse even if the tablet is subjected to physical manipulation and/or attempts at chemical extraction. “Laboratory test data demonstrated that, relative to another approved oxycodone immediate-release tablet, RoxyBond has increased resistance to cutting, crushing, grinding, or breaking using selected tools,” according to a statement from the company.
In addition, both intact and manipulated RoxyBond tablets resisted extraction in selected household and laboratory solvents under various conditions, including selected pre-treatments. Relative to oxycodone immediate-release tablets, the RoxyBond formulation forms a viscous material that resists passage through a needle; it was also more difficult to prepare solutions suitable for intravenous injection.
“The in vitro data demonstrate that RoxyBond has physicochemical properties expected to make abuse via injection difficult. However, abuse by the intranasal, oral, and intravenous route is still possible,” Inspirion said. A clinical abuse potential study was also conducted.
"As reflected in the prescribing information, the data from the clinical study, along with support from in vitro data, indicate that RoxyBond has physicochemical properties that are expected to reduce abuse by the intranasal route of administration," said Lynn R. Webster, MD, principal investigator of PRA Health Sciences in Salt Lake City, Utah.
Read more: How FDA aims to support generic opioids