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Charleston Laboratories and Daiichi Sankyo announced that a third Phase 3 clinical trial of CL-108, a novel opioid-containing formulation, met its primary endpoints for the treatment of moderate to severe pain and the prevention of opioid-induced nausea and vomiting (OINV).
The third Phase 3 trial was a randomized, double-blind, placebo- and active-controlled study in over 550 patients with moderate to severe pain post bunionectomy. Results from the study showed that CL-108 demonstrated significant pain relief and prevention of OINV (both P<0.001). Further study analysis is ongoing and detailed results will be submitted to an upcoming medical conference and peer-reviewed publication.
RELATED: FDA Approves Belbuca for Chronic Pain Management
CL-108 is a bi-layered tablet containing 7.5mg of hydrocodone and 325mg of acetaminophen uniquely formulated with 12.5mg of rapid-release promethazine.
For more information visit Charlestonlabs.com.
