BPCA study leads to pediatric label change

A Duke- and Stanford-led study has resulted in key changes being made to the label of a drug used routinely in children to control blood pressure in the perioperative environment. Scott Schulman, MD, of the Duke University Medical Center, in collaboration with co-principal investigator Gregory Hammer, MD, of the Stanford University Medical Center, oversaw this phase II, multicenter, randomized, double-blind, parallel group, dose-ranging, effect-controlled study to determine the dose-response relationship of sodium nitroprusside in pediatric subjects. The study was sponsored by the Eunice Kennedy Shriver National Institute of Child Health and Human Development under the Best Pharmaceuticals for Children Act. The revised drug label may be viewed at Daily Med.

“This is the first labeling change of an off-patent molecule in children under the BPCA mechanism based on a very challenging trial,” noted Danny Benjamin, MD, PhD, principal investigator for the Pediatric Trials Network (PTN), an NIH-supported research network conducting trials to improve drug labeling for children. “These BPCA trials, now led by the Duke Clinical Research Institute’s PTN, are typically unique in design and require substantial operational expertise. The team should be proud of the accomplishment.”