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DGAP-News: PAION AG / Key word(s): Study
PAION AG ANNOUNCES INITIATION OF PIVOTAL STUDY OF REMIMAZOLAM (BYFAVO(R)) IN PEDIATRIC PROCEDURAL SEDATION
The study will enroll approximately 100 children and adolescents aged up to and including 17 years at leading institutions across the United States and Denmark. If successful and upon approval by EMA (the EMA requires two pediatric studies) and FDA of a supplemental New Drug Application for remimazolam, it is expected that the EU and U.S. label of remimazolam will be expanded to include mild to moderate sedation for procedures in pediatric patients.
Dr. Jim Phillips, Chief Executive Officer of PAION AG, stated: "We are very pleased about the start of the study which is good news as the treatment of children can be an important area of application for remimazolam and look forward to the outcome of the study."
Dr. Gabriel Fox, Chief Medical Officer of Acacia, commented: "The need for moderate sedation in pediatric patients is substantial, covering a wide range of procedures, including, but not limited to, MRI and CT imaging, endoscopies, intravenous cannula placements, dental procedures, and painful wound and burn dressing changes. We are excited to be working with an outstanding group of pediatric sedation experts on this important initiative."
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" (ClinicalTrials.gov Identifier: NCT04851717), underpins the Pediatric Investigational Plan for remimazolam agreed with the EMA as well as the equivalent Pediatric Study Plan agreed with the FDA. As part of the EU approval, the EMA required the completion of the first of two studies until September 2023, and as part of the U.S. approval of remimazolam, FDA required the completion of this single study by July 2024. However, PAION and Acacia have elected to accelerate the conduct of the study significantly because of the important unmet medical need for remimazolam in pediatric procedural sedation.
In addition, PAION markets two intensive care products in selected European countries: Angiotensin II (GIAPREZA(R)), a vasoconstrictor indicated for the treatment of refractory hypotension in adults with septic or other distributive shock, and eravacycline (XERAVA(R)), a novel fluorocycline antibiotic indicated for the treatment of complicated intra-abdominal infections in adults.
PAION's mission is to be a leading specialty pharmaceutical company in the fields of anesthesia and critical care by bringing novel products to market to benefit patients, doctors and other stakeholders in healthcare.
PAION is headquartered in Aachen (Germany).
16.09.2021 Dissemination of a Corporate News, transmitted by DGAP - a service of EQS Group AG.
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