SAN DIEGO, Calif., April 16, 2026

Neurelis, Inc. has announced new clinical and real-world analyses demonstrating the effectiveness of its diazepam nasal spray (VALTOCO®) as an immediate-use seizure medication (ISM) for patients with epilepsy. The findings, to be presented at the American Academy of Neurology (AAN) 2026 Annual Meeting, highlight both rapid seizure termination and reduced healthcare resource utilization (HCRU), reinforcing the therapy’s role in improving patient outcomes and reducing the burden on healthcare systems.

Clinical Data Shows Rapid Seizure Termination

Neurelis presented a post-hoc analysis of pooled data from long-term safety studies, evaluating the use of diazepam nasal spray in both pediatric and adult patients aged 2 to 65 years. The data demonstrated that prehospital administration of the nasal spray enabled timely termination of status epilepticus (SE) episodes, including both generalized and focal seizures.

Importantly, the analysis showed that early intervention using an intranasal formulation significantly reduced seizure duration, with many cases resolving before requiring emergency medical care. Few seizure events required hospitalization, and none were directly linked to the treatment, highlighting the therapy’s strong safety and effectiveness profile. These findings support the growing adoption of non-invasive, rapid-response therapies in epilepsy management.

Real-World Evidence Demonstrates Reduced Healthcare Burden

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A second study presented by Neurelis analyzed real-world healthcare resource utilization (HCRU) using a large U.S. claims database of over 300 million patients. The retrospective analysis compared patients with epilepsy who were prescribed diazepam nasal spray against those who were not.

Results showed that patients using the nasal spray experienced significantly fewer inpatient and outpatient visits, along with lower hospital readmission rates. Additionally, overall epilepsy-related healthcare costs were reduced, demonstrating the therapy’s ability to deliver both clinical and economic benefits. These findings underscore the importance of early seizure intervention strategies in reducing long-term healthcare burden and improving patient quality of life.

Innovative Intranasal Delivery Enhances Patient Outcomes

VALTOCO® utilizes INTRAVAIL® transmucosal absorption technology, enabling rapid, non-invasive delivery of diazepam through the nasal mucosa. This innovative approach allows for immediate administration outside of hospital settings, making it particularly valuable in emergency situations such as seizure clusters and status epilepticus.

The therapy is FDA-approved for the acute treatment of seizure clusters in patients aged two years and older, and represents a significant advancement over traditional routes of administration. By enabling caregivers and patients to administer treatment quickly, VALTOCO® improves treatment accessibility, adherence, and clinical outcomes, particularly in community and prehospital settings.

Neurelis continues to expand its neuroscience pipeline, including investigational therapies targeting acute agitation and rare neurological disorders, further strengthening its position in CNS drug development and innovation.

Implications for Clinical Practice and GxP Compliance

The findings presented at AAN 2026 highlight a broader shift toward patient-centric, rapid-response treatment strategies in neurology, supported by both clinical trial data and real-world evidence. The integration of validated clinical endpoints, real-world data analytics, and regulatory-approved therapies underscores the importance of GxP-compliant development and post-market evaluation frameworks.

As epilepsy remains a chronic condition affecting millions globally, innovations such as intranasal seizure therapies are expected to play a key role in reducing emergency interventions, improving patient independence, and optimizing healthcare resource utilization.

The Neurelis data on diazepam nasal spray represents a significant advancement in epilepsy care, combining rapid clinical efficacy, strong safety profile, and real-world cost reduction benefits. By addressing both clinical outcomes and healthcare system challenges, VALTOCO® is positioned as a transformative therapy in seizure management, reinforcing Neurelis’ role in advancing innovative solutions for neurological disorders.

Source: Neurelis, Inc. press release