Specialty pharma company Protega Pharmaceuticals has won U.S. FDA approval for a 10 mg immediate-release version of its RoxyBond pain management tablet featuring abuse-deterrent technology.
RoxyBond, formulated with Protega's SentryBond Technology, is the first and only FDA-approved abuse-deterrent immediate-release oxycodone hydrochloride. The tablet is formulated with inactive ingredients that make it more difficult to manipulate for misuse and abuse even if the tablet is subjected to physical manipulation and/or chemical extraction.
RoxyBond was first approved in 2017 — in three dosage strengths: 5, 15 and 30 mg — for the management of pain severe enough to require an opioid analgesic and for which alternative treatments are inadequate. Protega, formerly Inspirion Delivery Sciences, had a U.S. commercialization deal with Daiichi Sankyo for the drug until the Japanese drugmaker exited the pain market and pulled out of the deal in 2019.
According to Protega, the addition of RoxyBond 10 mg tablet will "enhance flexibility and precision in opioid therapy, aiming to support both physicians and patients in achieving more effective and safer pain management outcomes." Offering a range of doses can provide better pain control, reduce the risk of side effects, and provide a smoother dosing transition.