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FDA Approves RoxyBond, an Abuse-Deterrent Oxycodone for Severe Pain

• The FDA has approved RoxyBond (oxycodone hydrochloride), an immediate-release tablet with abuse-deterrent properties, for managing severe pain requiring opioid analgesics. • RoxyBond utilizes SentryBond technology to resist physical and chemical manipulation, reducing the potential for misuse via crushing, dissolving, or injection. • Clinical data, including in vitro tests and human abuse potential studies, support RoxyBond's ability to deter abuse while maintaining its intended release profile. • While RoxyBond offers an alternative with abuse-deterrent features, it still carries risks of opioid addiction, respiratory depression, and other severe side effects.

Protega Pharmaceuticals' RoxyBond (oxycodone hydrochloride) has received FDA approval as a new option for managing severe pain. The immediate-release (IR) schedule II tablet, available in a 10 mg dose, is intended for patients whose pain necessitates an opioid analgesic when other treatments prove inadequate.
A key feature of RoxyBond is its formulation incorporating SentryBond abuse-deterrent technology. This technology employs physical and chemical methods to make the tablet more difficult to manipulate and abuse, without using aversive or antagonist agents. According to Protega, SentryBond is designed to maintain the intended release profile of extended-release products and delay the release of immediate-release products when subjected to physical manipulation or chemical extraction.

Abuse-Deterrent Properties

In vitro testing, involving over 2000 experiments, has demonstrated RoxyBond's resistance to crushing, cutting, breaking, and grinding. The formulation also resists chemical extraction and forms a viscous mass to prevent drawing through a needle. These properties are further supported by findings from a human abuse potential study.
Eric Kinzler, PhD, Vice President of Medical and Regulatory Affairs at Protega, stated, "Protega is dedicated to our mission to block the path to abuse and work with healthcare professionals across the continuum of care to reduce misuse and abuse. The development of ROXYBOND with SentryBond is a step forward in fighting the national epidemic of prescription opioid overdose."

Risks and Considerations

Despite its abuse-deterrent properties, RoxyBond carries the risk of opioid addiction and severe side effects, including life-threatening respiratory depression. Co-administration with benzodiazepines, alcohol, or other central nervous system depressants can exacerbate these risks, potentially leading to sedation, hypotension, coma, or death. Abuse via oral, intravenous, or intranasal routes remains possible. Clinicians must assess patients' risk of opioid addiction before prescribing RoxyBond.
Commonly reported adverse reactions include headache, vomiting or nausea, constipation, insomnia, dizziness, asthenia, pruritus, and somnolence.

Availability

Oxycodone hydrochloride is currently available in 5 mg, 15 mg, and 30 mg doses. The 10-mg IR tablets of RoxyBond are expected to be available before the end of 2024.
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Reference News

[1]
FDA Approves New Abuse-Deterrent Alternative for Severe Pain Management
ajmc.com · Oct 29, 2024

Protega Pharmaceuticals received FDA approval for oxycodone hydrochloride (RoxyBond) 10 mg immediate-release tablets wit...

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