The U.S. Food and Drug Administration (FDA) has approved Roxybond (oxycodone hydrochloride) immediate-release (IR) 10mg tablet, manufactured by Protega Pharmaceuticals, for the management of severe pain requiring opioid analgesics when alternative treatments are insufficient. This approval marks a significant advancement in providing pain relief while addressing concerns related to opioid abuse.
Roxybond incorporates SentryBond abuse-deterrent technology, a patented formulation designed to make the tablet more resistant to manipulation and extraction. This technology aims to reduce the likelihood of misuse and abuse through intranasal and intravenous routes.
Abuse-Deterrent Technology
SentryBond combines inactive excipients with active pharmaceutical ingredients to create a tablet that is difficult to crush, cut, grind, or dissolve. In vitro studies have demonstrated that Roxybond tablets exhibit increased resistance to physical manipulation and chemical extraction compared to oxycodone IR formulations. When manipulated, Roxybond becomes viscous, further hindering intravenous abuse.
Clinical Data
An intranasal abuse potential study revealed that Roxybond was associated with statistically significantly lower "drug liking" and "take drug again" scores compared to crushed intranasal oxycodone IR tablets. These findings suggest that Roxybond's abuse-deterrent properties may reduce its appeal for recreational use.
Expert Commentary
"The FDA approval of Roxybond 10mg with SentryBond is a significant milestone for Protega and fulfills an unmet need for an IR opioid with abuse-deterrent technology that may reduce misuse and abuse while providing pain relief to medically appropriate patients when used as indicated," stated Paul Howe, Chief Commercial Officer of Protega. He further added, "When manipulated, our innovative technology renders the pill more difficult to misuse or abuse, such as being cut or crushed to snort or inject."
Availability and Future Directions
Roxybond is already available in 5mg, 15mg, and 30mg tablets. Protega plans to launch the 10mg tablet before the end of the year. The company's SentryBond technology platform has the potential to be utilized in other medications to deter misuse and abuse, including hydromorphone, hydrocodone, and ADHD medications, pending FDA approval.
Implications for Pain Management
The addition of Roxybond 10mg can enhance flexibility and precision in opioid therapy, aiming to support both physicians and patients in achieving more effective and safer pain management outcomes. For patients, the range of doses can provide better pain control, reduce the risk of side effects, and provide a smoother transition during dosing transitions. For physicians, it can allow for more flexible dosing for pain levels, better titration, and help optimize risk management across diverse patient populations.
