Protega Pharmaceuticals Inc. has received FDA approval for ROXYBOND™ (oxycodone hydrochloride) immediate-release (IR) CII 10 mg tablet, indicated for the management of pain severe enough to require an opioid analgesic when alternative treatments are inadequate. ROXYBOND is the first and only FDA-approved abuse-deterrent immediate-release 10 mg oxycodone formulation expected to reduce abuse via intranasal and intravenous routes.
ROXYBOND incorporates SentryBond™ abuse-deterrent technology, a patented approach that combines inactive excipients with the active pharmaceutical ingredient, oxycodone. This formulation is designed to make the tablet more resistant to physical manipulation and chemical extraction, complicating misuse and abuse.
SentryBond Technology
SentryBond technology provides multiple layers of protection against physical manipulation, chemical extraction, and attempts to transform the drug for injection. According to Protega, the technology is designed to maintain the intended release profile for extended-release products and delay the release of immediate-release products. In vitro tests have demonstrated that ROXYBOND tablets are more difficult to manipulate compared to oxycodone IR, suggesting a reduced potential for abuse via intranasal and intravenous routes.
"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. "When manipulated, our innovative technology renders the pill more difficult to misuse or abuse, such as being cut or crushed to snort or inject."
Clinical Implications
ROXYBOND is already available in 5 mg, 15 mg, and 30 mg tablets. The addition of the 10 mg tablet aims to enhance flexibility and precision in opioid therapy, supporting physicians and patients in achieving more effective and safer pain management outcomes. The range of doses can provide better pain control, reduce the risk of side effects, and provide a smoother transition during dosing transitions. For physicians, it can allow for more flexible dosing for pain levels, better titration, and help optimize risk management across diverse patient populations.
Safety Information
ROXYBOND carries a boxed warning regarding serious and life-threatening risks, including addiction, abuse, and misuse, life-threatening respiratory depression, accidental ingestion, risks from concomitant use with benzodiazepines or other CNS depressants, and neonatal opioid withdrawal syndrome. It is contraindicated in patients with significant respiratory depression, acute or severe bronchial asthma, gastrointestinal obstruction, or known hypersensitivity to oxycodone.
Healthcare providers are encouraged to complete a REMS-compliant education program and counsel patients on the serious risks, safe use, and the importance of reading the Medication Guide with each prescription.
Protega's Mission
Protega Pharmaceuticals Inc. is focused on advancing prescription drug abuse deterrence through innovation and development. Their proprietary SentryBond abuse-deterrent technology is designed to provide multiple levels of protection and could potentially be utilized in other medications to help deter misuse and abuse. Protega plans to launch ROXYBOND 10 mg before the end of the year.
