FDA Approves Abuse-Deterrent 10 mg Oxycodone Hydrochloride for Severe Pain

The FDA has approved oxycodone hydrochloride (Roxybond) immediate-release (IR) CII 10 mg tablets for the management of severe pain that requires opioid analgesic treatment and for which alternative treatments are inadequate, according to a news release by developer Protega Pharmaceuticals.¹

The approval marks oxycodone hydrochloride as the first and only FDA-approved abuse-deterrent IR 10 mg oxycodone formulation intended to mitigate abuse via intranasal and intravenous administration.

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.

“The FDA approval of Roxybond 10 mg 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,” said Paul Howe, chief commercial officer of Protega, in the news release.¹ “When manipulated, our innovative technology renders the pill more difficult to misuse or abuse, such as being cut or crushed to snort or inject.”

READ MORE: Kentucky Sues Express Scripts for Role in Opioid Crisis

More than 2000 in vitro tests were conducted by Protega Pharmaceuticals to demonstrate that oxycodone hydrochloride is more resistant to manipulation compared to standard oxycodone IR. This data, in conjunction with the results of 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 noted that abuse is still possible by intranasal, intravenous, and oral routes.

“The development of Roxybond with SentryBond is a step forward in fighting the national epidemic of prescription opioid overdose,” said Eric Kinzler, PhD, VP of medical and regulatory affairs for Protega, in the same release.¹ “Protega is dedicated to our mission to block the path to abuse and work with health care 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.”

Prior to FDA approval of the 10 mg tablet, oxycodone hydrochloride was approved and 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 control, reduce side effects, and facilitate smoother transitions during dose adjustments for patients; for physicians, it can allow for more precise dosing adjustments, better titration, and optimized risk management across diverse patient populations.

Protega Pharmaceuticals plans to launch oxycodone hydrochloride 10 mg before the end of the year.

READ MORE: Pain Management Resource Center

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Reference

1. Protega Pharmaceuticals receives FDA approval for ROXYBOND (oxycodone hydrochloride) immediate-release 10 mg tablet with abuse-deterrent technology for management of pain. News release. Protega Pharma. October 29, 2024. Accessed October 29, 2024. https://www.prnewswire.com/news-releases/protega-pharmaceuticals-receives-fda-approval-for-roxybond-oxycodone-hydrochloride-immediate-release-10-mg-tablet-with-abuse-deterrent-technology-for-management-of-pain-302289975.html