FDA Approves Abuse-Deterrent 10 mg Oxycodone Hydrochloride for Severe Pain
Key Insights
The FDA has approved oxycodone hydrochloride 10 mg immediate-release tablets (Roxybond) for managing severe pain (search) where alternative treatments are inadequate.
This approval marks oxycodone hydrochloride as the first FDA-approved abuse-deterrent immediate-release 10 mg oxycodone formulation, designed to mitigate abuse via intranasal and intravenous routes.
The tablet is formulated with SentryBond technology, rendering it more resistant to physical manipulation and chemical extraction, reducing the risk of misuse.
The FDA has approved oxycodone hydrochloride (Roxybond) immediate-release (IR) CII 10 mg tablets, developed by Protega Pharmaceuticals (search), for the management of severe pain (search) that requires opioid analgesic treatment and for which alternative treatments are inadequate. This approval marks a significant advancement in pain management, providing an abuse-deterrent formulation of a commonly misused opioid.
Abuse-Deterrent Technology
Oxycodone hydrochloride is formulated with SentryBond abuse-deterrent technology. This patented technology combines inactive excipients with the active pharmaceutical ingredient to render the tablet more resistant to physical manipulation and chemical extraction, thereby mitigating the risk of misuse and abuse. SentryBond is designed to preserve the intended release profile of extended-release formulations and delay the release of IR formulations.
According to Paul Howe, chief commercial officer of Protega, the FDA approval of Roxybond 10 mg with SentryBond fulfills an unmet need for an IR opioid with abuse-deterrent technology. The technology makes the pill more difficult to misuse or abuse by cutting or crushing for snorting or injecting.
In Vitro Testing and Abuse Potential
Protega Pharmaceuticals (search) conducted over 2000 in vitro tests demonstrating that oxycodone hydrochloride is more resistant to manipulation compared to standard oxycodone IR. These data, along with human abuse potential studies, suggest that the physiochemical properties of oxycodone hydrochloride are expected to mitigate abuse via the intranasal and intravenous routes of administration. However, Protega acknowledges that abuse is still possible by intranasal, intravenous, and oral routes.
Addressing the Opioid Crisis
Eric Kinzler, PhD, VP of medical and regulatory affairs for Protega, stated that the development of Roxybond with SentryBond is a step forward in fighting the national epidemic of prescription opioid overdose (search). Protega is dedicated to blocking the path to abuse and working with healthcare professionals to reduce misuse and abuse. The company plans to responsibly launch Roxybond 10 mg and advance its innovative technology platform for potential application in other commonly abused prescription medications.
Enhanced Dosing Flexibility
Prior to this approval, oxycodone hydrochloride was available in 5 mg, 15 mg, and 30 mg tablet formulations. The addition of a 10 mg oxycodone hydrochloride tablet enhances dosing flexibility and precision. An expanded range of doses can improve pain (search) control, reduce side effects, and facilitate smoother transitions during dose adjustments for patients. For physicians, it allows for more precise dosing adjustments, better titration, and optimized risk management across diverse patient populations.
Protega Pharmaceuticals (search) plans to launch oxycodone hydrochloride 10 mg before the end of the year.