Inspirion Delivery Sciences announced that the Food and Drug Administration (FDA) has approved RoxyBond (oxycodone HCl) tablets, for the management of pain severe enough to require an opioid analgesic and for which alternative treatments are inadequate. 

RoxyBond is the first immediate-release opioid approved with abuse-deterrent labeling. It uses the Company’s SentryBond technology, which includes inactive ingredients that make the tablets harder to manipulate for misuse and abuse even under physical manipulation and/or chemical extraction. The tablet’s physical and chemical barriers help deter abuse without the use of opioid antagonists or aversive agents.  

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Lab tests have also shown RoxyBond to have higher resistance to cutting, crushing, grinding or breaking with selected tools when compared to another oxycodone immediate-release tablet. RoxyBond creates a viscous material that does not pass through a needle and in vitro data has shown the formulation to possess physicochemical properties that are expected to make abuse via injection difficult.  Abuse via intranasal, oral, and intravenous route is still possible. 

RoxyBond will be available as 5mg, 15mg, and 30mg strength tablets.

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