#United States #Atlanta #Epilepsy #Neurelis #VALTOCO

Neurelis Showcases Evidence of Efficacy for VALTOCO® at the American Epilepsy Society Annual Meeting

Neurelis, Inc. is set to participate in the highly anticipated American Epilepsy Society (AES) Annual Meeting, scheduled from December 5-9, 2025, in Atlanta. The company, celebrated for its innovative work with VALTOCO® (diazepam nasal spray), will present a collection of eight enlightening posters that explore the treatment of frequent seizure episodes in patients with epilepsy aged between 2 to 65 years.

The presentations predominantly rely on data derived from the recently concluded Stellina study, a comprehensive Phase 1/2a open-label investigation focusing on the pharmacokinetics (PK) and safety profile of diazepam nasal spray in young epilepsy patients aged 2-5 years. This demographic has now been incorporated into the usage indication for the VALTOCO treatment, marking a significant milestone in pediatric epilepsy management.

Safety and Effectiveness Highlights

Among the presented posters, six concentrate on data from the Stellina study. They assess critical metrics such as safety, the efficacy of single-dose administration, the time taken to stop seizures, and caregivers' feedback on seizure severity and quality of life. The importance of these findings cannot be overstated, as they indicate VALTOCO's potential to significantly enhance the treatment landscape for pediatric patients with epilepsy.

A noteworthy analysis featured in the presentations discusses how diazepam nasal spray can effectively manage status epilepticus (SE), defined by standards set forth by the International League Against Epilepsy (ILAE). This particular analysis combined data from both the Stellina study and a long-term Phase 3 safety trial, showcasing promising results for effective seizure management in young patients.

In addition to these vital studies, Neurelis will also unveil the outcomes of an exploratory post hoc analysis from the longitudinal safety study. It particularly emphasizes the minute-to-minute correlation between the administration of VALTOCO and the subsequent cessation of seizures when applied within five minutes after the onset of a seizure episode.

Statements from Leadership

Dr. Adrian L. Rabinowicz, the Chief Medical Officer of Neurelis, expressed pride in their contributions to the AES Annual Meeting, stating, "We are honored to present multiple posters this year that elucidate data from our studies concerning VALTOCO and its safety and efficacy for frequent seizure episodes. This event serves as a vital platform for the epilepsy community to unite towards improving health outcomes for individuals experiencing seizures."

In-Depth Look at Presentations

Among the topics set for discussion are:

• - Prehospital Treatment of Imminent Status Epilepticus with Diazepam Nasal Spray: This poster delves into pooled patient data from extensive long-term safety studies, aiming to assess the suitability of clinical criteria that monitor the duration and management of seizures in patients aged 2-17 years and 18-65 years. Results indicate swift seizure control with minimal need for hospitalization, showcasing the treatment's efficiency.
• - Examining Nasal and Respiratory Safety: Focusing on a young demographic (ages 2-5 years), this analysis highlights the excellent tolerability of diazepam nasal spray, noting that adverse events were minimal and transient. This reinforces confidence in the treatment's safety among pediatric patients.
• - Rapid Seizure Termination: This critical analysis underscored the significance of prompt treatment following seizure onset, with evidence pointing towards a marked reduction in seizure durations when diazepam was administered early. It further supports existing consensus recommendations for rapid intervention to prevent escalation to a seizure emergency.

The event provides an invaluable opportunity for Neurelis to engage with fellow clinicians, researchers, and advocates within the epilepsy community. By highlighting innovative findings, Neurelis aims to foster a deeper understanding of the strategies for improving seizure management through their therapeutic solutions.

About Neurelis

Neurelis, Inc. is dedicated to developing and commercializing therapeutic solutions aimed at treating epilepsy and neurological disorders, particularly those characterized by significant unmet medical needs. The FDA has recognized VALTOCO as an approved treatment for acute management of intermittent bouts of frequent seizure activity in patients aged two years and above. As part of its commitment to advancing seizure management, Neurelis is also exploring other investigational products aimed at addressing psychiatric and neurologic disorders. To stay updated about their progress, visit Neurelis' official website.