
FDA Approves New Abuse-Deterrent Alternative for Severe Pain Management
The FDA has approved oxycodone hydrochloride (RoxyBond) for the management of severe pain when other treatments have proved inadequate.
Today, Protega Pharmaceuticals announced that the
A key feature of this oxycodone hydrochloride is its formulation with
Over 2000 in vitro tests have been conducted to validate the abuse-deterrent nature of this formulation of oxycodone hydrochloride, results of which have suggested that the medication possesses a capacity to resist manipulation and were also supported by findings from a human abuse potential study.1
“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,” Eric Kinzler, PhD, vice president of medical and regulatory affairs, Protega, said in the news release. “The development of ROXYBOND with SentryBond is a step forward in fighting the national epidemic of prescription opioid overdose.”
The success of SentryBond technology for deterring potential abuse of medications could be extended to other medications, such as hydrocodone, drugs used for managing attention-deficit/hyperactivity disorder, and more, the press release suggested. However, its use in these medications has yet to receive an FDA approval.
When using this medication, patients are still at risk for opioid addiction and severe side effects when proper titration or dosing it not prescribed, such as life-threatening respiratory depression. This effect, along with a risk for degrees of sedation, hypotension, coma, and even death may be exacerbated by the use of this medication alongside benzodiazepines, alcohol, or other depressants that impact the central nervous system. Furthermore, it remains possible to abuse oxycodone hydrochloride via oral, intravenous, or intranasal routes. For this reason, it is imperative that clinicians assess patients’ risk for opioid addiction prior to initiating this treatment.
Commonly reported adverse reactions include headache, vomiting or nausea, constipation, insomnia, dizziness, asthenia, pruritus, and somnolence.
At present, oxycodone hydrochloride is already available at doses of 5 mg, 15 mg, and 30 mg. The IR 10-mg tablets are expected to become available before the end of 2024.
References
1. Protega Pharmaceuticals receives FDA approval for ROXYBOND (oxycodone hydrochloride) immediate-release 10 mg tablet with abuse-deterrent technology for management of pain. Protega. News release. October 29, 2024. Accessed October 29, 2024.
2. RoxyBond, featuring SentryBond abuse-deterrent technology. Accessed October 29, 2024.
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