CL 108 meets endpoints in Phase III trial for moderate to severe pain after bunionectomy- Charleston Labs + Daiichi Sankyo

Charleston Laboratories, Inc., and Daiichi Sankyo, Inc., announced that a third Phase III clinical trial of CL-108, an opioid-containing formulation, met its primary endpoints. CL-108 is a bi-layered tablet containing 7.5 mg of hydrocodone and 325 mg of acetaminophen uniquely formulated with 12.5 mg of rapid-release promethazine. This novel formulation is being developed as a treatment for moderate to severe pain and the prevention of opioid-induced nausea and vomiting (OINV).

The recently completed Phase III clinical trial was a randomized, double-blind, placebo- and active-controlled study in over 550 patients in the U.S. who experienced moderate to severe pain after bunionectomy surgery (removal of bunions from the foot). Results from the study demonstrated significant pain relief and prevention of OINV by CL-108 (both p<0.001). Further analysis of the study results is ongoing.