Today Protega Pharmaceuticals announced that the FDA approval granted for oxycodone hydrochloride (RoxyBond) as an alternative treatment for the treatment of severe pain. Approval has been granted for the use of a schedule II immediate-release (IR) tablet at a dose of 10 mg. This medication should only be administered to people whose pain requires an opioid analgesic in situations where other treatments have been inadequate.1
Oxycodone hydrochloride is approved for 10 mg immediate-release tablets as an alternative treatment for the treatment of severe pain | image credit: JAY – stock.adobe.com
An important feature of this oxycodone hydrochloride is its formulation SentryBond technology that deters abuse. The abuse-deterrent properties of oxycodone hydrochloride are achieved through various chemical and physical methods – and without the need for aversive or antagonistic agents – that make it more difficult to misuse, abuse and/or manipulate the tablet, according to the RoxyBond website: “ When SentryBond becomes subjected to physical manipulation and/or chemical extraction attempts, it is designed to maintain the intended release profile of extended-release products and delay the release of immediate-release products.”2 Using this technology, the tablets have shown to be more resistant to crushing, cutting, breaking or grinding, as well as resisting chemical extraction and even forming a viscous mass to prevent being pulled through a needle.
More than 2,000 in vitro tests have been conducted to validate the abuse-deterrent nature of this formulation of oxycodone hydrochloride. The results of this suggested that the drug has the ability to resist manipulation and were also supported by findings from a study of potential abuse in humans.1
“Protega is committed to our mission of blocking the path to abuse and working with healthcare professionals across the continuum of care to reduce misuse and abuse,” said Eric Kinzler, PhD, vice president of medical and regulatory affairs, Protega, in the press release. “The development of ROXYBOND with SentryBond is a step forward in the fight against the national epidemic of prescription opioid overdoses.”
The success of SentryBond technology in deterring potential drug abuse could be expanded to other medications, such as hydrocodone, medications used to manage attention-deficit/hyperactivity disorder, and more, the press release suggested. However, its use in these medications has yet to be approved by the FDA.
When using this medication, patients are still at risk for opioid addiction and serious side effects if proper titration or dosage is not prescribed, such as life-threatening respiratory depression. This effect, along with the risk of sedation, hypotension, coma, and even death, may be worsened by using this drug in addition to benzodiazepines, alcohol, or other sedatives that affect the central nervous system. In addition, it remains possible to abuse oxycodone hydrochloride via oral, intravenous, or intranasal routes. For this reason, it is imperative that physicians assess patients’ risk for opioid addiction before initiating this treatment.
Commonly reported side effects include headache, vomiting or nausea, constipation, insomnia, dizziness, asthenia, pruritus, and drowsiness.
Currently, oxycodone hydrochloride is already available in doses of 5 mg, 15 mg and 30 mg. The IR 10 mg tablets are expected to be available before the end of 2024.
References
1. Protega Pharmaceuticals receives FDA approval for ROXYBOND (oxycodone hydrochloride) 10 mg immediate-release tablet with abuse-deterrent technology for the treatment of pain. Protega. News item. 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-pain-relief-302289975.html
2. RoxyBond, with SentryBond technology that deters abuse. Accessed October 29, 2024.