Charleston's Anti-Emetic/Opioid Combo Flops At US FDA Panel Over Postmarketing, Dosage Concerns

 
• By Michael Cipriano
  
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Many of the advisory panel members felt the company's proposed buy-back program could not be feasible in practice.

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Charleston Laboratories Inc.'s Hydexor (hydrocodone, acetaminophen and promethazine) was unable to find any love this Valentine's Day, as FDA's Anesthetic and Analgesic Drug Products Advisory Committee and the Drug Safety and Risk Management Advisory Committee voted 19 to 2 against approval at a Feb. 14 meeting with concerns over what they felt was an unclear and impractical postmarketing plan.

Committee members specifically viewed Charleston's abuse mitigation measures, including its proposed buy-back program, as aspirational, but were not sold that...

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