The FDA has given the green light to RoxyBond (oxycodone hydrochloride, Inspirion Delivery Sciences) tablets for oral use, CII, for the management of pain severe enough to require an opioid analgesic and for which alternative treatments are inadequate. The product is an abuse-deterrent formulation of oxycodone that uses physical and chemical barriers to deter abuse, without the use of aversive agents or opioid antagonists.
RoxyBond is the first immediate-release opioid analgesic approved with labeling describing its abuse-deterrent properties. It is available in three dosage strengths: 5 mg, 15 mg, and 30 mg.
In April, a joint meeting of the FDA’s Anesthetic and Analgesic Drug Products Advisory Committee and its Drug Safety and Risk Management Advisory Committee voted 19 to 0 (with one abstention) to recommend approval of RoxyBond.
The product is formulated with inactive ingredients that make the tablet more difficult to manipulate for misuse and abuse even if the tablet is subjected to physical manipulation and/or attempts at chemical extraction. Laboratory test data have shown that, compared with another approved oxycodone immediate-release tablet, RoxyBond has increased resistance to cutting, crushing, grinding, or breaking using selected tools, according to Inspirion. In addition, both intact and manipulated RoxyBond tablets resisted extraction in selected household and laboratory solvents under various conditions, including selected pretreatments.
Compared with oxycodone immediate-release tablets, the RoxyBond formulation forms a viscous material that resists passage through a needle; it is also more difficult to prepare solutions suitable for intravenous injection. In vitro data have demonstrated that RoxyBond has physicochemical properties that are expected to make abuse via injection difficult. However, abuse by the intranasal, oral, and intravenous routes is still possible.
Source: PR Newswire; April 26, 2017.