(RTTNews) - Acacia Pharma Group plc said that it has initiated the U.S. Food and Drug Administration-mandated pivotal study investigating Byfavo or remimazolam injection in the moderate sedation of pediatric patients.
The company noted that the study will enroll about 100 children aged up to and including 17 years at leading institutions across the United States and Denmark. The Study is expected to take 9-12 months to complete.
If successful and upon approval by FDA of a supplemental New Drug Application for Byfavo, it is expected that the US label of Byfavo will be expanded to include moderate sedation for procedures in pediatric patients, the company said.
The Study, formally titled "A Phase 2/3, prospective, open-label trial evaluating the efficacy, safety, and pharmacokinetics of remimazolam for intravenous sedation in paediatric patients undergoing diagnostic and/or therapeutic procedures", underpins the Pediatric Study Plan for Byfavo agreed with FDA.
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