Charleston Ends Painkiller Trial Midway

Charleston Laboratories has ended its Phase III trial of CL-108 at the midway point. An independent Data Monitoring Committee reviewed the safety and efficacy results in an interim analysis and notified Charleston Labs that the study should be stopped because both efficacy endpoints of the study have been met. CL-108 is a strong pain reliever designed to also prevent nausea and vomiting.

The recommendation was based on the demonstration of the safety of CL-108, the significant effect on opioid-induced nausea and vomiting (OINV) compared to a commercial product, and the significant relief of moderate to severe pain. Charleston anticipates filing an NDA with the FDA upon finalization of clinical studies in the coming year.

CL-108 is a novel analgesic, combining 12.5 mg of immediate-release promethazine with 7.5 mg of hydrocodone and 325 mg of acetaminophen. It is indicated for patients who suffer from moderate to severe acute pain, such as post-operative pain, while significantly reducing or eliminating OINV.