FDA Approves Abuse Deterrent IR Oxycodone

The FDA has approved RoxyBond abuse-deterrent oxycodone hydrochloride tablets (RoxyBond, Inspirion) for the management of pain severe enough to require an opioid analgesic, and when alternative treatments are inadequate. The drug has multiple physical and chemical barriers that make it “more difficult and/or less rewarding” to abuse via intranasal or IV routes. For example, the drug creates a “viscous material that is difficult to syringe” when manipulated and subjected to a liquid environment, the drugmaker reports.

“RoxyBond represents the first and only immediate-release opioid approved by FDA with abuse-deterrent claims," said Jeffrey Gudin, MD, Department Director, Pain Management Center, Englewood Hospital and Medical Center, in New Jersey. "Oxycodone immediate-release tables 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."

Earlier in the year, an FDA panel recommended 19-0 with one abstention in favor of the drug’s approval. The panel said there was enough evidence to award abuse-deterrence labeling claims for both intranasal (19-1) and IV (16-4) routes of abuse.

Some panelists noted that this formulation could help to deter abuse but won’t eliminate it—and the new drug does not deter abuse via the oral route. Some members said there are insufficient postmarketing data to determine the efficacy of abuse-deterrent formulations in the real world.

RoxyBond is available in 5-, 15- and 30-mg tablets, and is designed for oral administration every four to six hours.
There are nine approved abuse-deterrent extended-release formulations, according to Inspirion.