#United States #Charlotte #Neurelis #VALTOCO #Pediatric Epilepsy

Neurelis Highlights Diazepam Nasal Spray at Child Neurology Society Annual Meeting

Neurelis, Inc., the creators of VALTOCO® (diazepam nasal spray), made a significant announcement regarding their innovative product. They will showcase two feature posters at the 54th Child Neurology Society Annual Meeting, taking place from October 8 to 11, 2025, in Charlotte, North Carolina.

The presentations will outline post hoc analyses from a recent open-label pharmacokinetics (PK) and safety study that examines VALTOCO’s effectiveness in treating frequent seizures in pediatric patients aged 2-5 years. The two main focal points of the presentations include insights into the timing of administration and effectiveness in terminating seizures, as well as the interval between episodes of frequent seizures following treatment.

Understanding the Results

In the first presentation, titled _Treatment of Prolonged Seizure and Status Epilepticus After T1 in Patients Aged 2-5 Years with Diazepam Nasal Spray: A Post Hoc Analysis (Poster #88)_, data derived from the phase 1/2a PK and safety study will be scrutinized. The analysis aims to depict how diazepam nasal spray effectively manages prolonged seizures (PS) and early status epilepticus (SE) within frequent seizure episodes. The results indicate that diazepam nasal spray can end PS swiftly (5-15 minutes post-onset) along with SE, paralleling prior analyses conducted on older populations, ranging from ages 6-65 years.

The second presentation, _Interval Between Seizure Clusters (SEIzure interVAL) Over Time in Pediatric Patients Enrolled in a Phase 1/2a Study of Diazepam Nasal Spray (Poster #58)_, explores the duration between treated seizure episodes (SEIVAL) in the same age group. The findings from this analysis reveal an increasing mean time interval between seizure clusters over 90-day periods as time passes—suggesting potential long-term advantages of VALTOCO as a medication for intermittent seizure episodes while aligning with earlier data observed in older patient demographics.

Expert Commentary on the Study Findings

Adrian L. Rabinowicz, MD, Chief Medical Officer of Neurelis, expressed enthusiasm about participating in the Annual Meeting, stating, "Engaging with the community in discussions aimed at improving care for children with neurological disorders is invaluable. Our focus remains on providing a user-friendly, effective, and safe treatment solution for individuals seeking help for epilepsy. Sharing data on diazepam nasal spray in the context of treating pediatric patients carries significant importance."

The Child Neurology Society Annual Meeting serves as a platform for experts within the child neurology field to connect, share research insights, and bolster patient care. Attendees can visit the presentations scheduled for October 9th during lunch from 12:30 PM to 1:45 PM ET and again from 5:30 PM to 7:00 PM ET during the evening reception.

About Neurelis

Neurelis, Inc. operates as a neuroscience company dedicated to developing and commercializing therapeutic solutions aimed at treating epilepsy and other neurological disorders facing high unmet medical needs. The U.S. FDA has approved Neurelis' VALTOCO® (diazepam nasal spray) as an emergency treatment for intermittent seizure activity, particularly seizure clusters and acute repetitive seizures in patients starting from age two. VALTOCO utilizes the INTRAVAIL® technology for enhanced transmucosal absorption.

In addition to VALTOCO, Neurelis is developing NRL-1004, a Phase 1 investigational intranasal olanzapine aimed at treating acute agitation linked to schizophrenia and bipolar disorder, as well as NRL-1049, an investigational Phase 1 Rho kinase inhibitor targeting cerebral cavernous malformations, a rare CNS disorder. For further details, please visit Neurelis' website or VALTOCO's dedicated site.