EGRX - Eagle Pharmaceuticals Awarded First Prize for Poster to Be Presented at the International Society for Anaesthetic Pharmacology 32nd Annual Meeting | Benzinga
-- Study reports on an interim analysis of the pharmacokinetics and pharmacodynamics of remimazolam and a subsequent model-based optimization of the dosing regimen that is being studied in the trial --
-- Prize money to be donated to the University of Groningen Medical Center ("UMCG") research fund, which supports the work of PhD students --
-- Eagle's BYFAVO® (remimazolam) for injection is approved for sedation in adults undergoing procedures lasting 30 minutes or less --
WOODCLIFF LAKE, N.J., Oct. 04, 2023 (GLOBE NEWSWIRE) -- Eagle Pharmaceuticals, Inc. (NASDAQ:EGRX) ("Eagle" or the "Company") today announced that its poster, to be presented at the International Society for Anaesthetic Pharmacology ("ISAP") 32nd Annual Meeting, has been awarded first prize. The presentation, entitled "Pharmacokinetics and pharmacodynamics of remimazolam for procedural sedation in children and adolescents," summarizes the results of the modeling of the remimazolam pharmacokinetic data by the University of Groningen Medical Center ("UMCG"). The annual ISAP meeting is being held on October 13, 2023, the first day of the American Society of Anesthesiologists ("ASA") Annual Meeting, in San Francisco, CA.
The model-informed drug development project was conceived by Eagle and executed in collaboration with UMCG to determine the appropriate dosing scheme for remimazolam in pediatric patients, as agreed upon with the U.S. Food and Drug Administration ("FDA").
"It is an honor to receive first-prize recognition for this important analysis," stated Valentin Curt, MD, Senior Vice President, Clinical Drug Development and Interim Chief Medical Officer at Eagle Pharmaceuticals. "We are pleased to be part of this dynamic scientific community and grateful for this acknowledgement as we share in the ISAP's mission to promote the study of anesthetic pharmacology."
Details of the poster presentation are as follows:
| Title: |
| Pharmacokinetics and pharmacodynamics of remimazolam for procedural sedation in children and adolescents |
| Date: |
| Friday, October 13, 2023 |
| Time: |
| 3:00pm – 4:30pm PT |
| Location: |
| Hilton Union Square, San Francisco |
Remimazolam, a short-acting benzodiazepine, is currently not approved for use in patients under 18 years of age. As part of the pediatric study plan agreed upon with the FDA, a clinical trial was initiated in 2021 to assess the efficacy and safety of IV remimazolam in inducing and maintaining appropriate sedation levels in pediatric patients undergoing diagnostic and/or therapeutic procedures. This poster presentation reports on an interim analysis of the pharmacokinetics and pharmacodynamics of remimazolam and a subsequent model-based optimization of the dosing regimen that was studied in the trial.
Used currently only in adults, Byfavo (remimazolam) is a rapid onset/offset procedural sedative with an established safety and efficacy profile and a broad label.
About BYFAVO® (remimazolam)1 Injection:
Byfavo is a novel benzodiazepine approved by the U.S. Food and Drug Administration in July 2020 for sedation in patients undergoing procedures less than 30 minutes in duration. Esterase metabolism and biotransformation to an inactive metabolite provide unique pharmacokinetic differences compared with other benzodiazepines. In May, the Centers for Medicare & Medicaid Services ("CMS") established a unique, product-specific billing code for Byfavo (remimazolam for injection), which became effective on July 1, 2023. For more information about Byfavo, visit byfavo.com.
About Eagle Pharmaceuticals, Inc.
Eagle is a fully integrated pharmaceutical company with research and development, clinical, manufacturing and commercial expertise. Eagle is committed to developing innovative medicines that result in meaningful improvements in patients' lives. Eagle's commercialized products include PEMFEXY®, RYANODEX®, BENDEKA®, BELRAPZO®, TREAKISYM® (Japan), and BYFAVO® and BARHEMSYS® through its wholly owned subsidiary Acacia Pharma Inc. Eagle's oncology and CNS/metabolic critical care pipeline includes product candidates with the potential to address underserved therapeutic areas across multiple disease states, and the company is focused on developing medicines with the potential to become part of the personalized medicine paradigm in cancer care. Additional information is available on Eagle's website at www.eagleus.com.
1 https://bynder.acaciapharma.com/m/403e8c343b2922de/original/Byfavo-PI.pdf
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