NEURELIS TO PRESENT ANALYSES OF IMMEDIATE-USE SEIZURE TREATMENT AT THE AMERICAN ACADEMY OF NEUROLOGY ANNUAL MEETING

Presentations to highlight analyses of both seizure termination and healthcare resource utilization as they relate to use of diazepam nasal spray

SAN DIEGO, April 16, 2026 /PRNewswire/ -- Neurelis, Inc., today announced details of two poster presentations at the American Academy of Neurology (AAN) Annual Meeting to be held April 18-22 in person in Chicago and online. The first presentation is a post-hoc analysis of pooled data from long-term safety studies evaluating the immediate-use seizure medication (ISM) diazepam nasal spray for the prehospital treatment of status epilepticus (SE) within seizure clusters. The second presentation explores findings from a retrospective real-world study comparing healthcare resource utilization (HCRU) in patients with epilepsy (PWE) with or without a prescription for diazepam nasal spray.

"Joining the neurology community at the AAN Annual Meeting is a highlight for Neurelis as we greatly value the time connecting with clinicians, researchers, and patients to discuss the latest advances in the epilepsy field," said Adrian L. Rabinowicz, MD, Neurelis Chief Medical Officer. "We are pleased to share our analyses on use of diazepam nasal spray ISM and its impact on seizure termination, as well as healthcare resource utilization, in continuing our mission to help people living with the challenges of epilepsy."

Neurelis' Annual Meeting presentations will occur on Sunday, April 19^th from 8:00 AM-9:00 AM CT.

• Prehospital Treatment of Status Epilepticus (SE) With Diazepam Nasal Spray in Pediatric and Adult Patients with Epilepsy (PWE) (Monitor 001 in Neighborhood 11)
  
  Intranasal ISMs have been recommended in the community as first-line treatment of SE. This analysis assessed prehospital use of diazepam nasal spray to treat SE occurring within seizure clusters in PWE aged 2-65 years. Data was pooled from patient diaries of a phase 3 long-term safety study of diazepam nasal spray in patients aged 6-65 years (N=163 patients) and a phase 1/2a pharmacokinetics and safety study in patients aged 2-5 years (N=36 patients). Generalized and focal SE episodes were mapped to the International League Against Epilepsy categories of tonic-clonic SE (timepoint t1, 5 minutes; timepoint t2, 30 minutes) and focal SE with impaired awareness (t1, 10 minutes; t2, 60 minutes). SE episodes were analyzed by time from seizure onset to dose and dose to seizure termination, total seizure duration, and termination time. Results showed prehospital use of diazepam nasal spray resulted in timely termination of SE episodes with generalized and/or focal seizures. Few SE events required hospitalization, and no hospitalizations were considered related to treatment.
  
  
• Healthcare Resource Utilization (HCRU) in Patients with Epilepsy (PWE): A Comparison of Diazepam Nasal Spray (DNS) vs No Use (Monitor 009 in Neighborhood 11)
  
  Despite receiving adequate antiseizure medication therapy, some PWE experience seizure clusters, which can increase HCRU. Using a US claims database of 300 million patients, this retrospective study compared real-world HCRU in matched cohorts of PWE with or without a prescription for diazepam nasal spray as an ISM. Results showed PWE with diazepam nasal spray had significantly fewer mean inpatient and outpatient visits and lower readmission rate versus a matched cohort. Overall mean epilepsy-related medical costs for inpatient and outpatient visits were lower among patients in the diazepam nasal spray cohort.

The American Academy of Neurology is committed to advancing brain disease treatment, cures, and prevention to promote brain health consistent with Neurelis' mission to improve quality of life and health outcomes for people with epilepsy and other neurologic disorders.

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

SOURCE Neurelis, Inc.