FDA Approves New Abuse-Deterrent Hydrocodone Product – Dental Regulations

In November 2014, the U. S. Food and Drug Administration (FDA) approved a new extended-release, single-entity opioid analgesic with abuse-deterrent properties. The drug, Hysingla ER, comes in tablet form that is difficult to crush, break, or dissolve, or as a thick gel that cannot be easily prepared for injection. Because it is a single-entity opioid and does not contain acetaminophen, Hysingla ER does not cause liver toxicity.

The FDA is requiring post-market studies of the new analgesic to assess the effectiveness of the abuse-deterrent features. Additionally, the manufacturer of Hysingla ER is required to provide healthcare professionals with educational guidance on how to safely prescribe the drug and patient information on its safe use, storage, and disposal.

For more information, visit FDA’s website.

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