Acacia Pharma Initiates Study Of Byfavo In Pediatric Procedural Sedation

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.

For comments and feedback contact: editorial@rttnews.com

Business News

Editors Pick
American Honda Motor Co, Inc. has recalled about 2,900 units of 2022 model year Honda TRX90X All-Terrain Vehicles (ATVs) sold in the United States for possible crash and injury hazard, according to a statement issued by the U.S. Consumer Product Safety Commission or CPSC. The Laundress, a unit of Conopco Inc. d/b/a Unilever, is recalling around 8 million laundry and household cleaning products citing risk of exposure to bacteria, U.S. Consumer Product Safety Commission. The recall involves Laundress laundry detergent, fabric conditioner and other cleaning products. Tesla Inc. has delivered its first Semi, a heavy-duty electric truck, to its customer PepsiCo Inc. during an event at its Nevada Gigafactory. The delivery of 500-mile fully electric Semi truck comes five years after the launch of the truck's prototype in 2017. During Thursday night's Semi Delivery Event at Tesla's Sparks, Nevada factory, CEO Elon Musk, with Dan Priestly, ...
Follow RTT