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Clinical Trials
0
0 active
Approvals
2
Total approvals
Agencies
1
Regulatory bodies
Founded
N/A
No trial phase data available
No trial data available
FDA
Food and Drug Administration
• The FDA has approved Protega Pharmaceuticals' ROXYBOND 10 mg, an immediate-release oxycodone hydrochloride tablet, for managing severe pain where 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. • Formulated with SentryBond technology, ROXYBOND resists physical and chemical manipulation, making it more difficult to misuse while maintaining its intended release profile. • Protega plans to launch ROXYBOND 10 mg before the year's end, providing clinicians with an additional tool for mitigating the risk of opioid abuse in pain management.