FDA panel votes against Charleston's pain candidate

FDA’s Anesthetic and Analgesic Drug Products and Drug Safety and Risk Management Advisory Committees voted 19-2 against approval of a resubmitted NDA for Hydexor (CL-108) from Charleston Laboratories Inc. (Jupiter, Fla.) to treat moderate to severe acute pain while preventing and reducing opioid-induced nausea and vomiting (OINV) for patients with pain severe enough to require an opioid.

FDA issued a complete response letter in February 2017 to an NDA from Charleston and then partner, Daiichi Sankyo Co. Ltd. (Tokyo:4568), for Hydrexor. In August, Daiichi terminated a 2014 deal to develop and commercialize Charleston's hydrocodone products in the U.S., including lead compound Hydexor. The private company regained all rights to the portfolio (see BioCentury, Feb. 8, 2017 & Sept. 1, 2017)...