Corgentech has announced positive safety and efficacy data from one of two pivotal Phase III studies of its lead product candidate, 3268. Data from the study demonstrated that 3268, a fast-acting local anesthetic, provided a statistically significant reduction in pain compared to placebo when administered just one to three minutes prior to venipuncture and intravenous (IV) line placement procedures in children.
The trial was conducted at six leading children's hospitals in the U.S. and enrolled 574 patients, three to 18 years of age. Patients received treatment with 3268 or placebo (an identical device but without drug) one to three minutes before venipuncture or intravenous line placement at the back of hand or antecubital fossa. The primary endpoint was child-rated pain (using the FACES pain scale) upon needle insertion.