Intellipharmaceutics has filed a New Drug Application (NDA) with the Food and Drug Administration (FDA) for Rexista, a formulation of extended-release oxycodone hydrochloride with abuse-deterrent properties.

Rexista is indicated for the management of pain severe enough to require daily, around-the-clock, long-term opioid treatment and for which alternative treatment options are inadequate. 

The submission is supported by studies demonstrating Rexista to be bioequivalent to OxyContin (oxycodone hydrochloride extended-release), and also abuse-deterrent studies which support label claims related to the abuse of the drug via oral, intranasal and intravenous pathways. 

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The Rexista tablet emits a stigmatizing blue dye once it is crushed, acting as a possible deterrent to oral or intranasal abuse. Additionally, when crushed and hydrated, the extended-release formation is designed to coagulate instantaneously and entrap the drug in a viscous hydrogel, preventing syringing, injecting and snorting. The abuse-deterrent label claims reference the FDA’s “Abuse-Deterrent Opioids – Evaluation and Labeling” guidance published in April 2015.

“This is our first NDA submission and the first abuse-deterrent oxycodone product candidate we are aware of that not only resists common forms of abuse but provides a preventive tool that may flag early warning of abuse,” said Dr. Isa Odidi, CEO of Intellipharmaceutics.

If approved, the extended release tablets would be available in 10mg, 15mg, 20mg, 30mg, 40mg, 60mg, and 80mg strengths. 

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