Discomfort With REMS Highlighted At Negative Hydexor Advisory Committee

US FDA advisory committee votes down Charleston’s emesis-reducing opioid once again, citing a poorly worded indication and REMS, along with a general lack of confidence that risk management plans can be successful in the real world.

FDA Advisory Committee Feature image — Charleston was unsuccessful at its second advisory committee for Hydexor

US Food and Drug Administration advisors’ general lack of confidence in risk evaluation and mitigation strategies ability to lessen safety concerns with drugs appeared to be a significant factor in the negative panel vote on 2 November against Charleston Laboratories, Inc.’s opioid combo Hydexor.

The Anesthetics and Analgesic Drugs Products Advisory Committee and Drug Safety and Risk Management Advisory Committee members who voted against...