1. Pink Sheet

US FDA’s Help May Get Charleston’s Hydexor Through Second Advisory Committee

 
• By Sarah Karlin-Smith

After appealing FDA’s rejection, Charleston narrowly tailored the proposed indication for its emesis-reducing opioid to an in-patient population and crafted its own REMS to try and address advisors past safety concerns. Briefing documents indicate the FDA might have been learning towards approving the drug on the earlier review cycle, but the initial advisory committee vote shifted the agency’s thinking.

Charleston had to narrowly tailor its drug indication after multiple FDA rejections • Source: Shutterstock

Charleston Laboratories, Inc. is betting that an extremely narrow indication and a strict risk management plan can propel Hydexor, an opioid combo designed to reduce emesis, through its second US Food and Drug Administration advisory committee and its fourth review cycle.

If the company is successful, the drug’s regulatory history may show how the agency’s help can get a long-troubled application over the finish line.

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