Neurelis Presents Seizure Cluster Studies at AES Annual Meeting

Neurelis, Inc. recently shared details of its presentations at the American Epilepsy Society (AES) Annual Meeting, set to take place from December 6-10 in Los Angeles. The company will present ten posters that analyze immediate-use seizure medication for treating seizure clusters.

The presentations will cover various aspects, such as pharmacokinetics (PK) and safety analyses from studies of VALTOCO® (diazepam nasal spray) for treating seizure clusters in patients aged 2-5 years. They will also address the time taken for treatment and termination of seizure clusters, the treatment of prolonged seizures within clusters, and potential drug effects beyond the immediate seizure cluster being treated. Additionally, implications of seizure clusters in the epilepsy monitoring unit and the development of evidence-based self-management criteria involving immediate-use seizure medication will be discussed.

Adrian L. Rabinowicz, MD, Chief Medical Officer at Neurelis, emphasized the importance of the AES Annual Meeting for the epilepsy community to engage in critical research and share advancements in the field. He expressed pride in the strong set of pre-clinical and clinical presentations that Neurelis will be presenting, and the opportunity to connect with healthcare practitioners, researchers, people with epilepsy, and their care partners.

Among the presentations is the "Exploring Proposed Recommendations for Acute Cluster Treatment and Rapid and Early Seizure Termination Using Data from a Long-Term Safety Study of Diazepam Nasal Spray." This presentation will provide data from a long-term safety study of diazepam nasal spray, examining its effectiveness in acute cluster treatment and rapid seizure termination. The findings suggest the benefit of using diazepam nasal spray for both terminating acute seizure clusters and prolonged seizures within clusters.

Another presentation, "Effect of Diazepam Intervention on Seizure-Cluster Expression in a Rat Model of Epilepsy," will share data from a preclinical study. The study investigates diazepam's impact on seizure cluster expression in a rat model of chronic epilepsy. The results indicate potential disease-modifying effects of diazepam on seizure clusters, including reduced severity and increased stability within clusters.

The poster "Is Disease Modification in Seizure Clusters Possible? Results From the Long-Term Safety Study of Diazepam Nasal Spray" will present a subgroup analysis of patients treated with diazepam nasal spray. This study aims to assess intervals between treated seizure clusters as a potential indicator of disease modification, with consistent results across various subgroups.

In the "Treatment of Prolonged Seizure with Diazepam Nasal Spray: A Post Hoc Cohort Analysis," prolonged seizures within clusters treated with diazepam nasal spray were examined. The analysis showed similar times to seizure termination across different age groups and seizure types, demonstrating the spray's effectiveness.

The "Pharmacokinetic Characteristics of Diazepam Nasal Spray in Children with Epilepsy 2 to 5 Years of Age" will highlight the consistent PK profile of the spray in young children, comparable to that in older children and adults. Additionally, the "Safety Profile of Diazepam Nasal Spray in Patients Aged 2-5 Years" will focus on the safety of the spray over a 180-day period, revealing a safety profile similar to that in older patients.

"Second Dose Use as a Proxy for Effectiveness of Diazepam Nasal Spray in Patients with Epilepsy Aged 2-5 Years" will evaluate the effectiveness of the spray by examining the use of second doses. The results show that second-dose rates in children aged 2-5 are comparable to those in older children, supporting the spray's effectiveness.

Another noteworthy presentation is "Potential Adverse Events of Clinical Interest with Use of Diazepam Nasal Spray in Children," which will assess treatment-emergent adverse events (TEAEs) in patients aged 2-5. The findings indicate uncommon and primarily nasal TEAEs, with no significant new safety signals.

The "Immediate-Use Seizure Medication for Acute Repetitive Seizures in the Epilepsy Monitoring Unit" presentation will discuss experiences from an expert panel on the use of immediate-use seizure medications in the epilepsy monitoring unit. Lastly, the "Development of Self-Management Tool for Individuals with Seizure Clusters" presentation will focus on integrating immediate-use seizure medications into self-management programs for individuals with epilepsy.

Neurelis is dedicated to advancing epilepsy treatment and improving the quality of life for those affected by the condition.