Inspirion Delivery Sciences, LLC announced that the United States Food and Drug Administration (FDA) has approved RoxyBond (oxycodone hydrochloride) tablets, for oral use, CII, indicated for the management of pain severe enough to require an opioid analgesic and for which alternative treatments are inadequate.
RoxyBond 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, consistent with the FDA’s 2015 Guidance for Industry: Abuse-Deterrent Opioids — Evaluation and Labeling. RoxyBond is approved in three dosage strengths: 5, 15, and 30mg.
RoxyBond, which uses Inspirion’s SentryBond technology, 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 demonstrated that, relative to another approved oxycodone immediate-release tablet, RoxyBond has increased resistance to cutting, crushing, grinding, or breaking using selected tools. In addition, both intact and manipulated RoxyBond tablets resisted extraction in selected household and laboratory solvents under various conditions, including selected pre-treatments.
Relative to oxycodone immediate-release tablets, the RoxyBond formulation forms a viscous material that resists passage through a needle; it was also more difficult to prepare solutions suitable for intravenous injection. The in vitro data demonstrate that RoxyBond has physicochemical properties expected to make abuse via injection difficult. However, abuse by the intranasal, oral, and intravenous route is still possible
A clinical abuse potential study was also conducted. “As reflected in the prescribing information, the data from the clinical study, along with support from in vitro data, also indicate that RoxyBond has physicochemical properties that are expected to reduce abuse by the intranasal route of administration,” said Lynn R. Webster, M.D., Principal Investigator, PRA Health Sciences, Salt Lake City, UT.
“RoxyBond represents the first and only immediate-release opioid approved by FDA with abuse-deterrent claims,” said Jeffrey Gudin, M.D., Department Director, Pain Management Center Englewood Hospital and Medical Center. Dr. Gudin went on to say, “Oxycodone immediate release opioid tablets are widely abused and the development of RoxyBond will offer clinicians a new approach for treating patients in pain while also fighting against the potential for abuse.”
On April 5, 2017, a joint meeting of the Anesthetic and Analgesic Drug Products Advisory Committee and Drug Safety and Risk Management Advisory Committee of the U.S. Food and Drug Administration voted 19 to 0 (with one abstention) to recommend approval of RoxyBond.
(Source: PR Newswire)
Filed Under: Drug Discovery