July 1, 2010 - Independent Data Monitoring Committee Sees Meaningful Efficacy in Multiple Treatment Arms Trial Focusing on Novel Droxidopa/Carbidopa Combination Therapy No Significant Adverse Events or Safety Concerns Observed in Any Treatment Arm - Chelsea Therapeutics International, Ltd. (Nasdaq:CHTP) announced the completion and favorable outcome of an independent Data Monitoring Committee (DMC) review of the safety and efficacy data from approximately half the target enrollment in Chelsea's Phase II trial of droxidopa in fibromyalgia.The purpose of this scheduled DMC meeting was to review the efficacy of each dose group and determine if the efficacy data supported dropping underperforming arms in order to increase the power in those arms most likely to demonstrate a clinically relevant therapeutic benefit. Following their assessment of each of the 12 arms using the study's primary endpoint, a reduction in pain as measured by the Short Form McGill Pain Questionnaire, the DMC recommended that 7 of the 12 arms of the trial be continued to completion. This recommendation was based solely on their efficacy analysis, as there were no observed safety concerns associated with any arm of the study. As a result of this recommendation, the study will now focus primarily on multiple doses of droxidopa in combination with 50mg carbidopa.
"The DMC's recommendation aligns with our assumption going into the trial that by pairing droxidopa with carbidopa to limit peripheral metabolism of droxidopa, we should be able to drive efficacy of droxidopa in the treatment of fibromyalgia... Chelsea Therapeutics' Press Release -
