First On-Label Abuse-Deterrent Opioid Approved

Immediate release formula provides effective pain relief while preventing abuse.

Drug developers and formulators have been working to help US regulators find solutions to the nation’s prescription pain medication addiction and abuse problem. The news that Inspirion Delivery Sciences’ immediate-release (IR) RoxyBond™ oxycodone hydrochloride tablet formulation was approved by the FDA. The company’s formulation is the first approved IR opioid analgesic with labeling describing the product’s abuse-deterrent properties, per the FDA's “2015 Guidance for Industry: Abuse-Deterrent Opioids – Evaluation and Labeling.”

Dr. Jeffrey Gudin, director of the the Pain Management and Palliative Care at Englewood Hospital and Medical Center in New Jersey, remarked that Inspirion’s formulation represents a breakthrough. “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," he said. 

According to Inspirion, it uses physical and chemical tools to deter abuse, without resorting to aversive agents or opioid antagonists. The company’s proprietary abuse-deterrent technology is formulated with inactive ingredients that make the tablet more difficult to misuse and abuse. Inspirion said its laboratory test data demonstrated that relative to other approved oxycodone IR tablets, their new formula has increased resistance to cutting, crushing, grinding, or breaking using selected tools.


Emilie Branch

Emilie is responsible for strategic content development based on scientific areas of specialty for Nice Insight research articles and for assisting client content development across a range of industry channels. Prior to joining Nice Insight, Emilie worked at a strategy-based consulting firm focused on consumer ethnographic research. She also has experience as a contributing editor, and has worked as a freelance writer for a host of news and trends-related publications