Neurelis to Present New Pediatric Data on VALTOCO® (Diazepam Nasal Spray) at 54th Child Neurology Society Annual Meeting

Neurelis, Inc., the neuroscience company behind VALTOCO® (diazepam nasal spray), announced it will present two new scientific posters at the 54th Child Neurology Society (CNS) Annual Meeting, taking place October 8–11, 2025, in Charlotte, North Carolina.

The presentations will share post hoc analyses from the company’s recently completed open-label pharmacokinetics (PK) and safety study evaluating diazepam nasal spray for treating episodes of frequent seizures in children aged 2–5 years with epilepsy.

Key Study Insights

The two posters will provide clinical insights into:

1. Timing of dosing and seizure termination in prolonged seizures (PS) and early status epilepticus (SE)
2. Seizure interVAL (SEIVAL) — a novel measure assessing the interval between seizure episodes over time as an indicator of potential long-term treatment benefit

“Neurelis is pleased to engage with the child neurology community to advance care for pediatric patients. Providing an easy-to-administer, efficacious, and safe treatment for epilepsy remains a core focus for us, and these data expand our understanding of VALTOCO’s role in very young patients.”

• Adrian L. Rabinowicz, MD, Chief Medical Officer of Neurelis.

Poster Presentations

1. Treatment of Prolonged Seizure and Status Epilepticus After T1 in Patients Aged 2–5 Years with Diazepam Nasal Spray: A Post Hoc Analysis (Poster #88)

• Analysis based on data from the Phase 1/2a PK and safety study
• Evaluated the treatment of prolonged seizures (5–15 minutes after onset) and early SE after timepoint T1
• Results demonstrated prompt and reliable seizure control with diazepam nasal spray
• Safety and efficacy findings were consistent with previous data in patients aged 6–65 years

2. Interval Between Seizure Clusters (SEIzure interVAL) Over Time in Pediatric Patients Enrolled in a Phase 1/2a Study of Diazepam Nasal Spray (Poster #58)

• Evaluated SEIVAL as a measure of interval duration between seizure clusters
• Findings showed increasing time intervals between treated seizure episodes over 90-day periods
• Results suggest a potential long-term therapeutic benefit of intermittent diazepam nasal spray use
• Safety outcomes in this younger cohort mirrored those seen in older patients

Both posters will be presented on Thursday, October 9th, from 12:30–1:45 PM ET (lunch session) and again from 5:30–7:00 PM ET (evening reception).

About VALTOCO® (Diazepam Nasal Spray)

VALTOCO® is an FDA-approved treatment for intermittent, stereotypic episodes of frequent seizure activity, commonly referred to as seizure clusters or acute repetitive seizures, in adult and pediatric patients aged 2 years and older.

VALTOCO incorporates INTRAVAIL® technology, which enhances transmucosal absorption and enables rapid, noninvasive delivery of diazepam for acute seizure control.

Important Safety Information

Indication: VALTOCO® (diazepam nasal spray) is indicated for the acute treatment of seizure clusters in patients with epilepsy aged 2 years and older.

Boxed Warning:

• Concomitant use with opioids may result in profound sedation, respiratory depression, coma, or death.
• Risk of abuse, misuse, and addiction exists with benzodiazepines.
• Physical dependence and withdrawal reactions can occur with frequent or prolonged use.

Contraindications:

• Hypersensitivity to diazepam
• Acute narrow-angle glaucoma

CNS Depression: VALTOCO may cause drowsiness or sedation. Patients should avoid hazardous activities (e.g., driving, operating machinery) until effects subside.

Additional Warnings:

• Risk of suicidal ideation or behavior (seen with antiepileptic drugs)
• Glaucoma risk: May increase intraocular pressure; contraindicated in narrow-angle glaucoma
• Neonatal risks: Sedation or withdrawal symptoms possible with late-pregnancy exposure
• Benzyl alcohol toxicity: Not approved for neonates or infants due to risk of gasping syndrome

Adverse Reactions: Most common (≥4%), somnolence, headache, and nasal discomfort

Controlled Substance: Diazepam is a Schedule IV controlled substance.

About Neurelis, Inc.

Neurelis, Inc. is a neuroscience-focused biopharmaceutical company dedicated to advancing therapeutics for epilepsy and neurological disorders with high unmet need.

Beyond VALTOCO®, the company is advancing:

• NRL-1004 — intranasal olanzapine for acute agitation in schizophrenia and bipolar disorder (Phase 1)

NRL-1049 (formerly BA-1049) — a Rho kinase (ROCK) inhibitor for cerebral cavernous malformations (CCMs) (Phase 1)

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