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FDA Approves New 10mg Dose of Abuse-Deterrent Oxycodone RoxyBond

• The FDA has approved a new 10 mg immediate-release tablet of RoxyBond (oxycodone hydrochloride) for managing pain where alternative treatments are inadequate. • RoxyBond utilizes SentryBond technology to resist physical manipulation, chemical extraction, and transformation for injection, offering multiple layers of abuse deterrence. • Testing shows RoxyBond has increased resistance to cutting, crushing, grinding, breaking, and extraction using common solvents, though abuse via intranasal, oral, and IV routes remains possible. • Protega Pharmaceuticals aims to expand the application of SentryBond technology to other commonly abused medications to combat prescription opioid misuse and abuse.

The FDA has approved a new 10 mg dose of RoxyBond (oxycodone hydrochloride) immediate-release tablets, developed by Protega Pharmaceuticals, for the management of pain severe enough to require an opioid analgesic when alternative treatments are inadequate. This approval expands the available dosages of RoxyBond, which was previously available in 5, 15, and 30 mg formulations, and marks the first abuse-deterrent 10 mg immediate-release oxycodone formulation to receive FDA approval.
RoxyBond incorporates the proprietary SentryBond technology, designed to deter abuse through multiple mechanisms. According to Protega Pharmaceuticals, SentryBond resists physical manipulation, chemical extraction, and attempts to transform the drug for injection. Eric Kinzler, PhD, Vice President of Medical and Regulatory Affairs for Protega, stated that the development of RoxyBond is "a step forward in fighting the national epidemic of prescription opioid overdose."

Abuse-Deterrent Properties

In vitro testing has demonstrated that RoxyBond exhibits higher resistance to common methods of tampering, including cutting, crushing, grinding, and breaking. The formulation also showed greater resistance to extraction using selected household and laboratory solvents and passage through a needle. However, the manufacturer cautions that abuse via intranasal, oral, and IV routes remains possible.

Addressing Opioid Abuse

The development of abuse-deterrent formulations like RoxyBond is part of a broader effort to combat the ongoing opioid crisis. While these formulations are not abuse-proof, they aim to reduce the likelihood of misuse and abuse by making it more difficult to manipulate the drug for alternative routes of administration. Protega Pharmaceuticals is exploring the potential application of SentryBond technology in other commonly abused prescription medications.

Future Applications of SentryBond Technology

Protega Pharmaceuticals aims to leverage its SentryBond technology platform for potential use in other medications that are commonly targets for abuse. While these uses are currently not available and require FDA approval, the technology can help in a variety of medications.
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Reference News

[1]
FDA approves new dose for abuse-deterrent oxycodone - Healio
healio.com · Oct 30, 2024

FDA approves RoxyBond 10 mg, the first 10 mg abuse-deterrent immediate-release oxycodone, using SentryBond technology to...

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