NEURELIS TO PRESENT ANALYSES OF STUDY DATA FROM PEDIATRIC PATIENTS WITH SEIZURE CLUSTERS AT THE CHILD NEUROLOGY SOCIETY ANNUAL MEETING

Posters to highlight assessments of treatment with immediate-use seizure medication

SAN DIEGO, Oct. 15, 2026 /PRNewswire/ -- Neurelis, Inc., a neuroscience company focused on the development and commercialization of therapeutics for the treatment of epilepsy and neurologic disorders characterized by high unmet medical need, announced today it will present three posters at the 55th Child Neurology Society Annual Meeting to be held October 14-17, 2026, in Montréal, Québec, Canada. The presentations will highlight analysis and impact of treatment with immediate-use seizure medication.

One presentation provides an analysis of pooled data from two studies evaluating diazepam nasal spray in pediatric patients with early tonic-clonic status epilepticus (SE) episodes within seizure clusters. A second presentation examines the increasing interval between treated seizure episodes (SEIVAL) in 70-day periods over time for the pediatric patients in these studies as a metric for evaluating potential drug effects beyond the termination of a seizure episode. A third presentation describes the characterization of seizure clusters in a large, real-world pediatric epilepsy database.

"We are pleased to join the child neurology community at this year's annual meeting to discuss the latest advances in research and clinical findings in the treatment of epilepsy and other chronic neurological conditions," said Adrian L. Rabinowicz, MD, Neurelis Chief Medical Officer. "There is a wealth of study data on treatment of seizure clusters in people with epilepsy, and we believe continued analyses can help provide meaningful insights for the care of people living with the challenges associated with the disease."

Treatment of Tonic-Clonic Status Epilepticus After T1 With Diazepam Nasal Spray in Patients Aged 2-17 Years: A Combined Cohort Analysis (Poster 76)

• This new combined cohort post-hoc analysis explored treatment of tonic-clonic SE within seizure clusters in patients aged 2-17 years treated with diazepam nasal spray from the phase 1/2a study of patients aged 2–5 years (N=36) and the phase 3 study of patients aged 6-65 years (n=78 aged 6-17 years).
• International League Against Epilepsy criteria for tonic-clonic SE (i.e., timepoint t1, 5 minutes; timepoint t2, 30 minutes) were used (n=266 SE episodes) in the analysis. Median time from SE onset to administration of diazepam nasal spray was 10 minutes. 
• Results: Median time from administration to SE termination was rapid at 5 minutes with a median seizure duration of 18.5 minutes. The majority of SE episodes (73.3%) were terminated before t2, with 59.8% terminating in the first 20 minutes after administration. A low proportion of SE episodes (6.4%) had SE recurrence in ≤24 hours after the initial SE termination. Most SE episodes (92.5%) were terminated after administration of a single dose of diazepam nasal spray.

Interval Between Seizure Clusters (SEIzure interVAL; SEIVAL) in Children Aged 2-17 Years Using 70-Day Analysis Periods in Two Studies (Poster 94)

• The novel SEIVAL metric for measuring the interval between treated seizure clusters over time was used to separately examine the mean time between seizure episodes in 70-day periods over time in patients aged 2-5 years and 6-17 years treated with diazepam nasal spray. 
• Results: For patients aged 2-5 years (n=22 patients with ≥1 SEIVALs) in the phase 1/2 study, overall mean SEIVAL duration doubled from 24.4 days in Period 1 to 49.4 days in Period 4. In a consistent cohort of patients with SEIVALs in each of the first 3 periods (n=8), there was an increase from 16.4 days in Period 1 to 21.2 days in Period 3. In the phase 3 study, 55 patients aged 6-17 years had ≥2 SEIVALs. Mean SEIVAL duration increased from 15.2 days in Period 1 to 28.8 days in Period 4 (n=46). No new safety signals were identified. These results were consistent with those previously calculated for 90-day SEIVAL periods in both pediatric and adult patients and suggest a beneficial long-term treatment effect of diazepam nasal spray as an intermittent seizure medication.

Frequency of Patient-Reported Seizure Clusters in a Clinical Dataset from a Pediatric Epilepsy Center in Canada (Poster 91)

• The prevalence, clinical characteristics, and immediate-use seizure rescue medication prescription patterns of patients with seizure clusters in a large, real-world pediatric epilepsy database containing data from the Comprehensive Children's Epilepsy Centre at Alberta Children's Hospital in Calgary were evaluated.
• A standardized point-of-care electronic health note was used to collect the data. Of 3588 patients with seizures, 466 marked yes for seizure clusters; 327 (9.1% of patients with seizures) met inclusion criteria for the seizure cluster population.
• Results: The most common known cause reported was genetic/metabolic (19.3% of the 259 patients), and the most common epilepsy syndrome reported was infantile epileptic spasms syndrome (23.8% of the 147 patients). A total of 65 patients in the seizure cluster population (19.9%) were prescribed a rescue medication. No new safety signals were identified. This dataset provides a rich resource for future investigation of seizure clusters and immediate-use seizure rescue medication.

The Child Neurology Society Annual Meeting provides an opportunity for members of the neurological disease clinical, research, and patient communities to engage in discussion and help advance patient care. The posters will be presented on Thursday, October 15 from 12:30 – 1:45 PM EDT and 5:30 – 7:00 PM EDT.

About Neurelis

Neurelis, Inc., is a neuroscience company focused on the development and commercialization of therapeutics for the treatment of epilepsy and neurologic disorders characterized by high unmet medical need. The FDA has approved Neurelis' VALTOCO® (diazepam nasal spray) as an acute treatment of intermittent, stereotypic episodes of frequent seizure activity (i.e., seizure clusters, acute repetitive seizures) that are distinct from an individual's usual seizure pattern in adult and pediatric patients 2 years of age and older. VALTOCO is a proprietary formulation of diazepam incorporating the science of INTRAVAIL®, a transmucosal absorption enhancement technology that enables the noninvasive delivery of a broad range of protein, peptide, and small-molecule drugs. For more information on VALTOCO, please visit www.valtoco.com. For the latest scientific information on VALTOCO, please visit http://www.neurelismedicalaffairs.com/. Neurelis is also developing NRL-1004, an investigational, Phase 1 stage intranasal olanzapine for treatment of acute agitation episodes associated with schizophrenia and bipolar disorder. In addition, Neurelis is also developing NRL-1049 (previously known as BA-1049), an investigational, Phase 1 new chemical entity Rho kinase (ROCK) inhibitor, for the treatment of cerebral cavernous malformations (CCMS), a rare disorder of the central nervous system (CNS). For more information on Neurelis, please visit www.neurelis.com. 

Important Safety Information about VALTOCO:

Indication

VALTOCO^® (diazepam nasal spray) is indicated for the acute treatment of intermittent, stereotypic episodes of frequent seizure activity (i.e., seizure clusters, acute repetitive seizures) that are distinct from a patient's usual seizure pattern in patients with epilepsy 2 years of age and older.

WARNING: RISKS FROM CONCOMITANT USE WITH OPIOIDS; ABUSE, MISUSE, AND ADDICTION; and DEPENDENCE AND WITHDRAWAL REACTIONS

• Concomitant use of benzodiazepines and opioids may result in profound sedation, respiratory depression, coma, and death. Reserve concomitant prescribing of these drugs for patients for whom alternative treatment options are inadequate. Limit dosages and durations to the minimum required. Follow patients for signs and symptoms of respiratory depression and sedation.
• The use of benzodiazepines, including VALTOCO, exposes users to risks of abuse, misuse, and addiction, which can lead to overdose or death. Abuse and misuse of benzodiazepines commonly involve concomitant use of other medications, alcohol, and/or illicit substances, which is associated with an increased frequency of serious adverse outcomes. Before prescribing VALTOCO and throughout treatment, assess each patient's risk for abuse, misuse, and addiction.
• The continued use of benzodiazepines may lead to clinically significant physical dependence. The risks of dependence and withdrawal increase with longer treatment duration and higher daily dose. Although VALTOCO is indicated only for intermittent use, if used more frequently than recommended, abrupt discontinuation or rapid dosage reduction of VALTOCO may precipitate acute withdrawal reactions, which can be life-threatening. For patients using VALTOCO more frequently than recommended, to reduce the risk of withdrawal reactions, use a gradual taper to discontinue VALTOCO. 

Contraindications: VALTOCO is contraindicated in patients with:

• Hypersensitivity to diazepam
• Acute narrow-angle glaucoma

Central Nervous System (CNS) Depression
Benzodiazepines, including VALTOCO, may produce CNS depression. Caution patients against engaging in hazardous activities requiring mental alertness, such as operating machinery, driving a motor vehicle, or riding a bicycle, until the effects of the drug, such as drowsiness, have subsided, and as their medical condition permits.

The potential for a synergistic CNS-depressant effect when VALTOCO is used with alcohol or other CNS depressants must be considered, and appropriate recommendations made to the patient and/or care partner.

Suicidal Behavior and Ideation
Antiepileptic drugs (AEDs), including VALTOCO, increase the risk of suicidal ideation and behavior. Patients treated with any AED for any indication should be monitored for the emergence or worsening of depression, suicidal thoughts or behavior, and/or unusual changes in mood or behavior.

Glaucoma
Benzodiazepines, including VALTOCO, can increase intraocular pressure in patients with glaucoma. VALTOCO may only be used in patients with open-angle glaucoma only if they are receiving appropriate therapy. VALTOCO is contraindicated in patients with narrow-angle glaucoma.

Neonatal Sedation and Withdrawal Syndrome
Use of VALTOCO late in pregnancy can result in sedation (respiratory depression, lethargy, hypotonia) and/or withdrawal symptoms (hyperreflexia, irritability, restlessness, tremors, inconsolable crying, and feeding difficulties) in the neonate. Monitor neonates exposed to VALTOCO during pregnancy or labor for signs of sedation and monitor neonates exposed to VALTOCO during pregnancy for signs of withdrawal; manage these neonates accordingly.

Risk of Serious Adverse Reactions in Infants due to Benzyl Alcohol Preservative
VALTOCO is not approved for use in neonates or infants. Serious and fatal adverse reactions, including "gasping syndrome," can occur in neonates and low-birth-weight infants treated with benzyl alcohol–preserved drugs, including VALTOCO. The "gasping syndrome" is characterized by central nervous system depression, metabolic acidosis, and gasping respirations. The minimum amount of benzyl alcohol at which serious adverse reactions may occur is not known.

Adverse Reactions
The most common adverse reactions (at least 4%) were somnolence, headache, and nasal discomfort.

Diazepam, the active ingredient in VALTOCO, is a Schedule IV controlled substance.

To report SUSPECTED ADVERSE REACTIONS, contact Neurelis, Inc. at 1-866-696-3873 or FDA at 1-800-FDA-1088 (www.fda.gov/medwatch).

Please read full Prescribing Information, including Boxed Warning.

Contacts:

Marie Rossi, PhD, Public and Investor Relations, [email protected], +1 858 251 2100

SOURCE Neurelis, Inc.