US FDA Proactively Exploring Hydexor Abuse Potential Ahead Of Ad Comm For Anti-Emetic/Opioid Combo

Charleston Labs is not seeking abuse-deterrent labeling for Hydexor, but FDA has been monitoring online web forums to spot patterns of abuse of the active ingredients to determine if inclusion of promethazine translates to greater risk of abuse than for other hydrocodone products.

The US FDA is looking to get out in front of potential misuse and abuse in its review of Charleston Laboratories Inc.'s non-abuse-deterrent opioid Hydexor (hydrocodone, acetaminophen and promethazine), as the agency is proactively exploring trends and patterns on online drug forums in advance of the drug's advisory committee meeting.

The agency's Anesthetic and Analgesic Drug Products Advisory Committee and Drug Safety and Risk Management Advisory Committee will meet in...

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