Protega Pharmaceuticals Inc. announced FDA approval of ROXYBOND™ (oxycodone hydrochloride) immediate-release 10 mg tablets, a CII opioid analgesic, for managing severe pain where alternative treatments are inadequate. The approval marks a significant advancement due to ROXYBOND's abuse-deterrent properties.
SentryBond™ Technology
ROXYBOND™ utilizes Protega's patented SentryBond™ technology, which integrates inactive excipients with oxycodone hydrochloride to resist physical and chemical manipulation. This innovative formulation aims to reduce the potential for misuse and abuse via intranasal and intravenous routes, while maintaining the drug's immediate-release profile.
According to Paul Howe, Chief Commercial Officer of Protega, this approval addresses an unmet need for immediate-release opioids with abuse-deterrent technology. The SentryBond™ technology makes the tablet more difficult to crush, cut, snort, or inject, thereby reducing common methods of abuse.
Clinical Data and Abuse Deterrence
Over 2000 in vitro tests demonstrated that ROXYBOND™ tablets are more difficult to manipulate compared to traditional oxycodone IR formulations. These data, combined with human abuse potential studies, indicate that ROXYBOND™ is expected to reduce abuse via intranasal and intravenous routes. However, Protega notes that abuse is still possible through these and oral routes.
Eric Kinzler, Ph.D., VP Medical and Regulatory Affairs for Protega, emphasized the importance of ROXYBOND™ in combating the prescription opioid overdose epidemic. Protega is committed to blocking the path to abuse and collaborating with healthcare professionals to reduce misuse.
Dosage and Availability
ROXYBOND™ 10 mg will join the already available 5 mg, 15 mg, and 30 mg tablets. Protega plans to launch the 10 mg dosage before the end of the year. This expanded range of dosages aims to provide clinicians with enhanced flexibility and precision in opioid therapy, supporting safer and more effective pain management.
The availability of ROXYBOND™ 10 mg can help physicians tailor opioid therapy to individual patient needs, potentially improving pain control, reducing side effects, and facilitating smoother dosing transitions. This is particularly beneficial for patients requiring precise titration to manage varying pain levels.
Important Safety Information
ROXYBOND™ carries a boxed warning regarding serious and life-threatening risks, including addiction, abuse, and misuse, as well as life-threatening respiratory depression and accidental ingestion, especially in children. Concomitant use with benzodiazepines or other CNS depressants, including alcohol, can result in profound sedation, respiratory depression, coma, and death. Healthcare providers are strongly encouraged to complete a REMS-compliant education program and to counsel patients and caregivers on serious risks, safe use, and the importance of reading the Medication Guide with each prescription.
