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Tighter REMS For Zohydro ER Still Insufficient For FDA Advisory Panel

 
• By Cathy Dombrowski

FDA’s Anesthetic and Analgesic Drug Products Advisory Committee wants Risk Evaluation and Mitigation Strategies enhanced for all extended-release/long-acting opioids as it recommends 11-2, one abstention, against approval of Zogenix’s single-entity hydrocodone product.

Zogenix Inc. offered a Risk Evaluation and Mitigation Strategy for its single-entity hydrocodone Zohydro ER that was more extensive than the class-wide REMS imposed on extended-release/long-acting opioid drugs, but FDA’s Anesthetic and Analgesic Drug Products Advisory Committee still found it wanting as it voted the product down at its Dec. 7 meeting. The panel’s focus on general risk management concerns, however, offers a ray of hope for the sponsor.

The 11-2 vote against approval, with one abstention, reflected the panel’s dissatisfaction with risk management of the ER/LA opioid class of drugs, and members urged FDA to tighten the class-wide REMS that was imposed on ER/LA opioid manufacturers in July Also see "

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