A new formulation of the opioid oxycodone has been approved by the US Food & Drug Administration (FDA), providing doctors with a new option for treating patients in pain. RoxyBond (oxycodone hydrochloride) is the first immediate-release opioid analgesic with labeling for abuse-deterrent qualities, as described in the FDA's 2015 Guidance for Industry: Abuse-Deterrent Opioids – Evaluation and Labeling. The medication was developed by Inspirion Delivery Sciences and formulated with inactive ingredients to discourage abuse.

Oxycodone is an opioid painkiller with a high potential for abuse. In 2015, around two million Americans over the age of 12 had a substance use disorder involving prescription painkillers, according to the American Society of Addiction Medicine. Stefan Aigner MD, CFA and CEO of Inspirion, observed nearly 18 million prescriptions for immediate release oxycodone hydrochloride are filled every year in the US. He added the FDA approval of RoxyBond will help address a "long standing unmet need for immediate release abuse deterrent opioids".

RoxyBond uses Inspirion's SentryBond technology, which makes it harder to abuse or misuse the tablets, even if chemical extraction or physical manipulation (grinding, crushing, cutting or breaking) is attempted. The tablets are resistant to chemical extraction using laboratory or household solvents and form a viscous material resistant to passage through a needle. Clinical studies also suggested RoxyBond's psychochemical properties may reduce intranasal abuse of the drug.   

"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," stated Jeffrey Gudin MD, department director at the Pain Management Center Englewood Hospital and Medical Center. 

RoxyBond tablets are indicated for use managing severe pain that require an opioid analgesic and for which other treatments (such as non-opioid analgesics and opioid combinations) are insufficient. The FDA has approved 5mg, 15mg and 30mg RoxyBond tablets.

RoxyBond should not be used by patients with (among other conditions) significant respiratory depression, hypersensitivity to oxycodone, gastrointestinal obstruction or severe bronchial asthma. Earlier this month, the FDA issued new warnings about the dangers of treating children with the opioids codeine and tramadol. For more information about indications and contraindications of RoxyBond, visit the link below.  

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