Pharmacokinetics of Midazolam Nasal Spray in Pediatric Subjects with Epilepsy (S55.005)

Conclusions:MDZ was rapidly absorbed with no observed dose-dependent Cmax differences; AUC values for MDZ were highest following 5.0 mg USL261. MDZ PK parameters were similar regardless of CYP3A4/5-inducing AED status. 1-OH-MDZ AUC and Cmax were similar across cohorts and higher in subjects taking CYP3A4/5-inducing AEDs. Tmax for 1-OH-MDZ was slightly longer than for MDZ. These PK results support the continued development of USL261 in pediatric patients with epilepsy.Study Supported by: Upsher-Smith Laboratories, Inc.Disclosure: Dr. Berg has received personal compensation for activities with Upsher-Smith Laboratories, Inc. as an employee. Dr. Bancke has received person compensation for activities with Upsher-Smith Laboratories, Inc. as an employee. Dr. Kapelan has received personal compensation for activities with Upsher-Smith Laboratories, Inc. as an employee. Dr. Meng has received personal compensation for activities with Upsher-Smith Laboratories, Inc. as an employee. Dr. Moe has receievd personal compensation for activities with Upsher-Smith Laboratories, Inc. as an employee. Dr. Van Ess has received personal compensation for activities with Upsher-Smith Laboratories Inc. as an employee.

Source: Neurology - April 17, 2017 Category: Neurology Authors: Berg, A., Bancke, L., Kapelan, B., Meng, T.-C., Moe, C., Van Ess, P. Tags: Epilepsy and Clinical Neurophysiology (EEG) III Source Type: research