PRINCETON, N.J - Protega Pharmaceuticals Inc. announced today that the U.S. Food and Drug Administration (FDA) has approved ROXYBOND™ (oxycodone hydrochloride) immediate-release (IR) CII 10 mg tablet for the management of pain severe enough to require an opioid analgesic and for which alternative treatments are inadequate. ROXYBOND is the first and only FDA-approved abuse-deterrent IR 10 mg oxycodone formulation that is expected to reduce abuse by intranasal and intravenous routes.*
ROXYBOND is formulated with SentryBond™ abuse-deterrent technology. This patented technology combines inactive excipients with active pharmaceutical ingredients to make the tablet more difficult to manipulate for misuse and abuse, even if it is subjected to physical manipulation and/or chemical extraction. SentryBond is designed to maintain the intended release profile of extended-release (ER) products and delay the release of IR products.
"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."
Protega's SentryBond technology is a first-of-its-kind abuse-deterrent patented technology. It is designed to provide multiple levels of protection that resist physical manipulation, chemical extraction, and manipulation or transformation for injection. Protega's proprietary SentryBond technology platform could potentially be utilized in other medications to help deter misuse and abuse, e.g., hydromorphone, hydrocodone, and attention deficit hyperactivity disorder (ADHD) medications. While these uses are currently not available and require FDA approval, the technology can help in a variety of medications.
"The development of ROXYBOND with SentryBond is a step forward in fighting the national epidemic of prescription opioid overdose," said Eric Kinzler, Ph.D., VP Medical and Regulatory Affairs for Protega. "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. We look forward to responsibly launching ROXYBOND 10 mg and advancing our innovative technology platform for potential application in other commonly abused prescription medications."
More than 2000 in vitro tests were conducted to demonstrate ROXYBOND tablets were difficult to manipulate vs oxycodone IR, this data, along with the results of the human abuse potential study, suggest that the physicochemical properties of ROXYBOND are expected to reduce abuse via the intranasal and intravenous routes of administration. However, abuse is still possible by intranasal, intravenous, and oral routes.
In addition to the FDA approval for the 10 mg tablet, ROXYBOND was previously approved and is already available in 5 mg, 15 mg, and 30 mg tablets. Protega plans to launch ROXYBOND 10 mg before the end of the year, providing clinicians with another risk mitigation tool they can use when treating patients with severe pain.
The addition of ROXYBOND 10 mg can enhance flexibility and precision in opioid therapy, aiming to support both physicians and patients in achieving more effective and safer pain management outcomes. For patients, 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.
