Neurelis, Inc. announced today that it will present three poster analyses of its diazepam nasal spray (VALTOCO®) at the upcoming American Academy of Neurology (AAN) Annual Meeting, taking place April 5-9, 2025, in San Diego and online. The presentations will focus on post hoc analyses of clinical data evaluating the medication's effectiveness in treating various seizure scenarios.
The analyses examine the nasal spray's performance in early at-home treatment of status epilepticus (SE), acute seizure termination, and management of prolonged seizures—all critical concerns for patients with epilepsy who experience seizure clusters.
"We are pleased to join the neurology community at this year's AAN Annual Meeting to discuss the latest learnings on treatments for people with epilepsy and other neurological disorders," said Adrian L. Rabinowicz, MD, Neurelis Chief Medical Officer. "We look forward to sharing our additional analyses of data from studies of immediate-use seizure medication and joining the dialogue on clinical research that has the potential to meaningfully impact those living with the challenges of epilepsy."
Effective Management of Status Epilepticus
On April 8, Neurelis will present findings from a post hoc analysis of pooled data from two long-term, open-label safety studies investigating the treatment of early status epilepticus episodes in patients with epilepsy aged 2-65 years.
The analysis defined early SE episodes as seizures continuing after Time Point 1 (t1)—5 minutes for generalized seizures and 10 minutes for focal and unclassified seizures. Among 97 patients experiencing 671 events of t1 SE, diazepam nasal spray provided timely control of these episodes.
Importantly, the safety profile remained consistent with the established profile of diazepam nasal spray, and most episodes did not result in hospitalization due to serious treatment-emergent adverse events. A responder analysis revealed that the majority of early SE seizures terminated prior to Time Point 2, when neuronal injury may occur (30 minutes for generalized seizures and 60 minutes for focal seizures).
Treatment of Prolonged Seizures
A second poster, scheduled for April 9, will present a post hoc subgroup analysis assessing the effectiveness of diazepam nasal spray in treating prolonged seizures (5-15 minutes post onset) within seizure clusters. The analysis examined 727 events from a long-term safety study involving patients aged 6-65 years.
Results showed generally similar times to seizure termination across age groups, seizure types, and high treatment usage subgroups. Notably, the use of second doses within 24 hours for prolonged seizures was low (9.3%) and generally consistent across subgroups, demonstrating preserved first-dose effectiveness even in seizures that have become prolonged.
Supporting Expert Recommendations for Acute Seizure Management
The third poster will explore how clinical data from the long-term safety study of diazepam nasal spray aligns with recent expert consensus recommendations for terminating acute clusters and ongoing seizures expected to be prolonged.
Analysis of 3,225 administrations demonstrated the effectiveness of diazepam nasal spray in preventing further seizures in a cluster, as evidenced by the low use of second doses across 24 hours. The data also showed rapid and early seizure termination, particularly when treatment was administered within 5 minutes of seizure onset—reinforcing the importance of early intervention.
Clinical Significance for Epilepsy Management
These findings have significant implications for epilepsy management, particularly for patients who experience seizure clusters or status epilepticus. Early intervention with an effective rescue medication can potentially prevent progression to more severe seizure states and reduce the risk of neuronal injury.
The data support a growing consensus among epilepsy specialists that immediate-use seizure medications should be readily available to patients at risk for seizure clusters, with clear instructions for early administration.
About VALTOCO®
VALTOCO® (diazepam nasal spray) is FDA-approved for the acute treatment of intermittent, stereotypic episodes of frequent seizure activity (seizure clusters, acute repetitive seizures) that differ from a patient's usual seizure pattern in patients with epilepsy 6 years of age and older.
The medication utilizes Neurelis' proprietary formulation of diazepam incorporating INTRAVAIL®, a transmucosal absorption enhancement technology that enables noninvasive delivery of a broad range of protein, peptide, and small-molecule drugs.
Broader Pipeline Development
Beyond VALTOCO®, Neurelis is advancing other neurological treatments, including NRL-1004, an investigational Phase 1 intranasal olanzapine for acute agitation episodes associated with schizophrenia and bipolar disorder. The company is also developing NRL-1049, a Phase 1 Rho kinase (ROCK) inhibitor for the treatment of cerebral cavernous malformations, a rare central nervous system disorder.
The AAN Annual Meeting serves as a premier forum for neurologists and neuroscience professionals to share research advances and clinical best practices. Neurelis' participation underscores the company's commitment to advancing treatment options for patients with epilepsy and other neurological conditions characterized by high unmet medical needs.
