By Sabela Ojea

Acacia Pharma Group PLC said Thursday that it has initiated its Food and Drug Administration-mandated study to investigate its Byfavo sedative drug in the moderate sedation of pediatric patients.

The biopharmaceutical company said the study, which is expected to take between nine and 12 months to complete, will enroll approximately 100 children aged up to and including 17 years in the U.S. and Denmark. the United States and Denmark.

"If successful and upon approval by FDA of a supplemental new drug application for Byfavo, it is expected that the U.S. label of Byfavo will be expanded to include moderate sedation for procedures in pediatric patients," it added.

Write to Sabela Ojea at sabela.ojea@wsj.com; @sabelaojeaguix

(END) Dow Jones Newswires

09-16-21 0125ET