RxTrials Institute Drug Pipeline Alert

A pivotal Phase III clinical study of polidocanol, conducted by BioForm Medical’s partner Chemische Fabrik Kreussler, successfully met its primary endpoint, and results have been submitted to the FDA as part of an NDA process.
 
In the study, 338 patients with C1 varicose veins were randomized to receive either polidocanol, sodium-tetradecyl-sulfate (STS) or a placebo control. Patient photos were taken of a defined area of the leg. They were rated by the treating physicians and two blinded evaluators, serving as the basis for efficacy assessment.

The trial successfully met its primary efficacy endpoint with superiority of polidocanol compared with placebo. The treatment success rates for polidocanol were 96 percent and 95 percent at 12 and 26 weeks compared with STS (92 percent, 91 percent) and placebo (8 percent, 6 percent), BioForm said.