FDA Advisory Committee recommends approval of immediate-release oxycodone formulation, RoxyBond, an abuse-deterrent oxycodone tablet to treat chronic pain.- Inspirion Delivery Sciences

The Anesthetic and Analgesic Drug Products Advisory Committee and the Drug Safety and Risk Management Advisory Committee, voted 19-0 with one abstention, in favor of approval of the immediate-release oxycodone formulation, RoxyBond from Inspirion Delivery Sciences, for the treatment of chronic pain. RoxyBond is an abuse-deterrent oxycodone tablet indicated 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 panel considered that 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 will not eliminate abuse. 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.