Neurelis Data Reinforces VALTOCO as a New Standard in Epilepsy Care

ATLANTA, GA – December 05, 2025 – Neurelis, Inc. is presenting a compelling body of new clinical data at the American Epilepsy Society (AES) Annual Meeting this week, further cementing the role of its VALTOCO® (diazepam nasal spray) as a cornerstone therapy for acute seizure management. The eight poster presentations provide robust validation for the treatment’s safety and effectiveness, particularly in very young children and in the critical moments of a seizure emergency, signaling a significant step forward for patients and caregivers navigating the challenges of epilepsy.

The data, drawn from multiple studies including the comprehensive long-term Stellina study, focuses on the use of the nasal spray for episodes of frequent seizures in patients from ages 2 to 65. These findings, presented at one of the world's most influential epilepsy conferences, are poised to reinforce clinical best practices and expand confidence in VALTOCO as a critical rescue medication.

A Breakthrough for the Youngest Patients

A major highlight of the AES presentations is the wealth of data focused on pediatric patients aged 2 to 5 years. This vulnerable population has historically had limited, often challenging, options for out-of-hospital seizure rescue. The FDA's expansion of VALTOCO's approval to this age group in April 2025 was a landmark decision, and the new data provides powerful real-world evidence supporting that move.

Analyses from the Phase 1/2a Stellina study demonstrate a strong safety and tolerability profile in these young children, comparable to that seen in older patients. According to the findings, local treatment-emergent adverse events like nasal discomfort were uncommon, mild, and transient. Crucially, no serious treatment-related adverse events, including respiratory depression, were observed. The study also highlighted the device’s suitability, noting a dosing error rate of less than 1%, a testament to its ease of use even in a pediatric emergency.

For caregivers, these findings offer profound relief. The alternative, diazepam rectal gel, can be socially awkward and difficult to administer, especially in public or during a convulsive seizure. VALTOCO's non-invasive intranasal delivery, powered by the proprietary INTRAVAIL® absorption enhancement technology, provides a faster, simpler, and more dignified method of administration. Data from a Caregiver Assessment instrument presented at the meeting confirmed this, showing that caregivers experienced improvements in their own activities of daily living, underscoring the positive ripple effect that an effective and easy-to-use rescue therapy can have on the entire family. In one analysis, a single dose was effective in 82% of seizure episodes in this young age group, mirroring results in older populations and supporting the prescribed dosing strategy.

The Criticality of Rapid Intervention

Beyond the pediatric focus, Neurelis’s data powerfully reinforces a core principle of modern epilepsy care: speed matters. An expert consensus has long recommended rapid and early intervention to prevent seizure clusters from escalating into status epilepticus, a life-threatening medical emergency. The new analyses provide definitive clinical support for this guidance.

One key presentation detailed a minute-by-minute subgroup analysis from a long-term safety study in patients aged 6-65. The results were clear: earlier administration of VALTOCO was directly associated with a shorter time to seizure termination. For seizures treated within five minutes of onset, the median time to cessation was just one minute. This climbed to three minutes when treatment was administered between 5-15 minutes, and nine minutes if treatment was delayed beyond 15 minutes. This dose-timing relationship held true across different seizure types and age groups, providing a powerful therapeutic argument for immediate action at the first sign of a seizure cluster.

Another vital analysis pooled data to explore VALTOCO's effectiveness in treating impending status epilepticus (SE), as defined by the International League Against Epilepsy (ILAE). The findings showed that VALTOCO provided rapid and consistent control of early SE, with most seizures terminating before reaching the critical time point (t2) where long-term consequences may occur. Furthermore, rates of seizure recurrence within 24 hours and hospitalization for SE were low, suggesting that effective at-home intervention with VALTOCO can prevent the need for more intensive emergency medical care, reducing both the burden on the healthcare system and the trauma for the patient.

Solidifying Market Leadership Through Clinical Excellence

These comprehensive data presentations are not just a win for patients; they are a strategic triumph for Neurelis. In the competitive landscape of acute seizure treatments, which includes UCB's Nayzilam (midazolam nasal spray) and generic diazepam rectal gel, robust clinical evidence is the ultimate differentiator. By continuously investing in research that validates VALTOCO's efficacy, safety, and real-world utility across a wide patient spectrum, Neurelis is solidifying its market leadership.

The FDA's previous designation of VALTOCO as "clinically superior" to the rectal gel formulation, which granted it orphan drug exclusivity, was an early indicator of its innovative potential. The INTRAVAIL® technology, which allows for rapid and reliable drug absorption through the nasal mucosa, remains a key competitive advantage. The new data, especially for the 2-5 age group where Nayzilam is not approved, carves out an even stronger position for VALTOCO as the go-to rescue therapy for a broader range of patients.

The findings also suggest a potential long-term beneficial effect. One analysis examined the interval between treated seizure clusters (SEIVAL) and found a substantial lengthening of this interval over time. This suggests that intermittent use of VALTOCO may not only stop an active seizure cluster but could also contribute to a longer period of stability for the patient, a finding that adds another layer of value to the treatment.

Ensuring Safety and Accessibility

While celebrating its effectiveness, Neurelis remains transparent about VALTOCO's safety profile, which is consistent with the known effects of benzodiazepines. As a Schedule IV controlled substance, it carries a boxed warning regarding risks from use with opioids, potential for abuse and dependence, and withdrawal reactions. The most common adverse reactions reported are somnolence, headache, and nasal discomfort. These are important considerations for physicians and patients, and Neurelis emphasizes adherence to prescribing guidelines, which recommend limiting use to no more than five episodes per month.

Recognizing that innovation is only impactful if it is accessible, Neurelis has also established a comprehensive patient support ecosystem. Through the "myNEURELIS" program, the company offers services ranging from insurance benefit verification to a copay card that can lower out-of-pocket costs for commercially insured patients to as little as $20. For those who are uninsured or underinsured, a Patient Assistance Program may provide VALTOCO at no cost. This multi-pronged approach to accessibility ensures that the clinical benefits demonstrated in these latest studies can translate into tangible improvements in the lives of people with epilepsy. The broad coverage by commercial insurance and Medicare Part D plans further facilitates patient access to this critical medication.

The extensive data presented at the AES meeting provides a multi-faceted view of VALTOCO's impact, confirming its role as a reliable, fast-acting, and easy-to-use rescue therapy that improves outcomes for patients and eases the immense burden carried by their families.