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NEURELIS TO PRESENT CLINICAL DATA AT AMERICAN EPILEPSY SOCIETY ANNUAL MEETING

PR Newswire · 2d ago

Collection of eight posters include analyses of data from studies of diazepam nasal spray in treatment of episodes of frequent seizures in people with epilepsy aged 2-65 years

SAN DIEGO, Dec. 5, 2025 /PRNewswire/ -- Neurelis, Inc., the innovator behind VALTOCO® (diazepam nasal spray), today announced it will participate in the American Epilepsy Society (AES) Annual Meeting December 5-9, 2025 in Atlanta. The Company will present a collection of eight posters focused on evaluation of diazepam nasal spray for the treatment of episodes of frequent seizures in people with epilepsy aged 2-65 years.

Six of Neurelis' posters include analyses of data from the completed Stellina study, which was a long-term, Phase 1/2a, open-label pharmacokinetics (PK) and safety study that investigated diazepam nasal spray for the treatment of episodes of frequent seizures in patients with epilepsy aged 2-5 years, an age group now included in the indication for diazepam nasal spray. These presentations examine safety, single-dose effectiveness, time to seizure cessation, interval between treated seizure episodes over time, and caregiver responses to seizure severity and quality of life assessments.

Additionally, one presentation explores administration of diazepam nasal spray for status epilepticus (SE), as defined by International League Against Epilepsy (ILAE) criteria, occurring within an episode of frequent seizures. This analysis uses pooled data gathered from the Stellina study in patients aged 2-5 and a long-term, Phase 3 safety study of diazepam nasal spray in patients aged 6-65 years.

The final presentation reports findings from an exploratory post hoc analysis of the long-term safety study in patients aged 6-65 years. This analysis specifically examined the minute-by-minute relationship between the timing of diazepam nasal spray administration and the associated timing of seizure termination, when administered within five minutes of seizure cluster onset.

"We are proud to present multiple posters this year highlighting data from our studies of diazepam nasal spray and its safety and effectiveness in treatment of episodes of frequent seizures," said Adrian L. Rabinowicz, MD, Neurelis Chief Medical Officer. "The AES Annual Meeting is an important opportunity for the epilepsy community to come together with a shared focus on improving health outcomes for people with epilepsy. We look forward to engaging fellow clinicians, researchers, and epilepsy advocates to discuss the latest scientific and clinical advances."

Neurelis' presentations at the Annual Meeting include the following.

December 7th, Session 2, 12-2:00 PM ET

  • Prehospital Treatment of Impending Status Epilepticus with Diazepam Nasal Spray (Poster #2.35)

    Pooled patient diary data from the two long-term safety studies of diazepam nasal spray for episodes of frequent seizures were analyzed to assess the treatment of early status epilepticus in patients aged 2-17 years and 18-65 years. The analysis mapped seizure types to established ILAE criteria, using two critical time points: t1, when seizures are abnormally prolonged, and t2, when long-term consequences may occur. Overall, median total seizure durations were ≤t2 for most seizure categories, with a high proportion of patients achieving SE termination by or before t2. There were low rates of seizure recurrence 24 hours post-SE termination, use of >1 dose of diazepam nasal spray per episode, and hospitalization for SE. Collectively, these analyses demonstrate that treatment with diazepam nasal spray provided consistent and rapid control of early SE.



  • Examining Nasal and Respiratory Safety of Diazepam Nasal Spray and Device Suitability for Children with Epilepsy Aged 2-5 Years (Poster #2.335)

    Data from the Stellina study were analyzed for nasal tolerability and device appropriateness, revealing that local treatment-emergent adverse events (TEAEs) were uncommon, with the few that were reported being mild and transient. Additionally, there was a low rate of dosing errors (<1%) in these young patients. No serious treatment-related TEAEs, including respiratory depression, were observed. These findings are comparable to those seen in studies in older children and adults, further supporting the diazepam nasal spray safety profile in the 2-5 year age group.



  • Rapid Termination of Seizures in a Cluster: Minute-by-Minute Subgroup Analysis of Prompt Treatment with Diazepam Nasal Spray (Poster #2.336)

    An expert consensus recommends rapid and early seizure termination to avoid progression to a seizure emergency. In this analysis using data from the long-term safety study of diazepam nasal spray in patients aged 6-65 years, time to administration in the first 5 minutes after seizure cluster onset and associated seizure termination was examined. Among 2169 treated seizure clusters, earlier administration was associated with a shorter time to seizure termination and shorter seizure duration for generalized, focal, and indeterminable seizure types, in patients aged 6-17 years and 18-65 years, providing therapeutic support for the consensus recommendation.

December 8th, Session 3, 12-1:45 PM ET

  • Second Dose Usage as a Proxy for Effectiveness of Diazepam Nasal Spray in Patients with Epilepsy Aged 2-5 Years: Final Results of a Phase 1/2a Study (Poster #3.35)

    Seizure diary data from the Stellina study were evaluated using >1 dose of diazepam nasal spray within 24 hours as a proxy for effectiveness in patients aged 2-5 years. Results showed 82% of 339 total episodes of frequent seizures were treated with a single dose of diazepam nasal spray (based on patient age and weight (0.5 mg/kg)), similar to observations in patients aged 6-65 years in the separate long-term safety study of diazepam nasal spray. These findings support the effectiveness of the 0.5 mg/kg dose in patients aged 2-5 years.



  • Interval Between Seizure Clusters (SEIzure interVAL) in Children Aged 2-5 Years: Final Analysis from a Phase 1/2a Study of Diazepam Nasal Spray (Poster #3.348)

    The interval between treated seizure clusters (SEIVAL) was examined in a presentation of data from the Stellina study. Data showed substantial lengthening of mean SEIVAL using both 70-day periods and 90-day periods, consistent with results in patients aged 6-65 years. These findings suggest a beneficial long-term treatment effect of diazepam nasal spray as an intermittent seizure medication.



  • Temporal Patterns of Dosing and Seizure Cessation in Children Aged 2-5 Years: Final Results from a Phase 1/2a Study of Diazepam Nasal Spray (Poster #3.349)

    Seizure diary data from the Stellina study were evaluated for patterns of dosing and seizure cessation. Earlier treatment with diazepam nasal spray was associated with more rapid seizure cessation and shorter overall seizure duration. For seizures treated within 5 minutes, 5-15 minutes, and >15 minutes, median times to seizure cessation were 1, 3, and 9 minutes, respectively. These data were consistent with temporal patterns observed in older children and adults treated with diazepam nasal spray in the long-term safety study of patients aged 6-65 years.



  • Final, Long-Term Safety Results for Diazepam Nasal Spray in Patients Aged 2-5 Years from a Phase 1/2a Study (Poster #3.357)

    Final safety results from the Stellina study were reported in 36 children with epilepsy, aged 2-5 years, who received at least one dose of diazepam nasal spray. The mean duration of participation in the study was >15 months. Treatment-related TEAEs were reported in 7 patients during the Open Label Safety Period (N=36) and 1 patient during the Optional Extension Period (N=27), with no serious treatment-related TEAEs reported. There were no study discontinuations or deaths due to TEAEs. Overall, the safety profile of diazepam nasal spray for seizure clusters in children aged 2-5 years was consistent with that seen in older children and adults.



  • Caregiver Perceptions of Diazepam Nasal Spray Treatment in Children Aged 2-5 Years (Poster #3.358)

    During Stellina site visits, the validated Seizure Severity Questionnaire and a novel Caregiver Assessment instrument were administered to document the experiences of caregivers of epilepsy patients aged 2-5 years, treated with diazepam nasal spray. Caregivers' responses reflected improvement in their activities of daily living for themselves and their families. These insights reinforce the value of appropriate seizure cluster management.

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:

Brittany Bradrick, Chief Operating Officer and Chief Financial Officer, +1 858 251 2100

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SOURCE Neurelis, Inc.