Abuse-Deterrent Opioid Receives FDA Approval

The FDA recently approved RoxyBond (oxycodone hydrochloride) immediate-release tablets in 5 mg, 15 mg, 30 mg dosage strengths for the management of severe pain that does not respond to alternative treatment and requires an opioid analgesic.

RoxyBond is the first immediate-release opioid analgesic to received FDA approval with a label describing its abuse-deterrent properties under the FDA 2015 Guidance for Industry: Abuse-Deterrent Opioids—Evaluation and Labelling.
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The drug is formulated with inactive ingredients making it more difficult to misuse and abuse. When compared with another approved oxycodone immediate-release tablet, RoxyBond was shown to be more resistant to cutting, crushing, grinding, or breaking, and more resistant to extraction.

Adverse events associated with RoxyBond include nausea, constipation, vomiting, headache, pruritus, insomnia, dizziness, asthenia, somnolence, and addiction.

—Melissa Weiss

Reference:

Inspirion delivery sciences receives FDA approval for RoxyBond™ (oxycodone hydrochloride) tablets cii, the first and only immediate release opioid analgesic with abuse-deterrent label claims [press release]. Basking Ridge, New Jersey. April 26, 2017. http://www.prnewswire.com/news-releases/inspirion-delivery-sciences-receives-fda-approval-for-roxybond-oxycodone-hydrochloride-tablets-cii-the-first-and-only-immediate-release-opioid-analgesic-with-abuse-deterrent-label-claims-300445964.html.