FDA approves RoxyBond (oxycodone hydrochloride) immediate-release for the management of severe pain
Protega Pharmaceuticals Inc., an innovative specialty pharmaceutical company focused on responsible pain management and the development of novel abuse-deterrent products, announced that the 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.
Protega's innovative 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.
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.
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