NEURELIS TO PARTICIPATE IN SOFIE’S JOURNEY EPILEPSY AWARENESS DAY AND EDUCATION EXPO AT DISNEYLAND® RESORT

Company will be joined by its Ambassadors to engage epilepsy community and share their journeys

SAN DIEGO, Nov. 10, 2025 /PRNewswire/ -- Neurelis, Inc., the innovator behind VALTOCO® (diazepam nasal spray), today announced it will join the epilepsy community at the 13th Annual Sofie’s Journey Epilepsy Awareness Day & Education Expo at Disneyland (EADDL), one of the largest gatherings of people with epilepsy, care partners, and healthcare practitioners. This event was established to help meet the need for increased epilepsy education. 

As part of November's National Epilepsy Awareness Month, Neurelis will participate in the free education expo on November 10th and 11th from 9:00 AM to 5:00 PM PT at the Disneyland Hotel Convention Center, followed by Epilepsy Awareness Day on November 12th at Disneyland Resort, where families will spend the day in the park together.

"EADDL is a truly meaningful event where people can come together to raise seizure awareness and help one another find support within a community that understands the challenges of living with epilepsy," commented Lowell, Neurelis Ambassador and active adult with epilepsy who advocates for seizure awareness in his role as a regional director of an epilepsy foundation.  "I am honored to represent Neurelis at this year's event and share my experience with VALTOCO, an immediate-use seizure medication that has provided me a comfort and confidence in managing my episodes of frequent seizures while doing the activities I love."

Neurelis will sponsor a presentation by Lowell, who will share his journey and speak about his experience with Neurelis' FDA-approved product VALTOCO, a treatment for episodes of frequent seizures in patients two years of age and older.  His presentation is on Tuesday November 11th from 11‑11:30 AM in the Expo Center, New Therapies & Specialty Care, followed by a Q&A session.

The company will also be joined at the event by Ambassador Esteban, a resilient college graduate with episodes of frequent seizures, who went through surgery and multiple medication changes to find the right combination that helped him regain his freedom. Esteban will speak about his experiences living with epilepsy on Monday November 10th at a dinner for families attending the meeting, which is co-sponsored by Epilepsy Alliance of America.

"When I was initially diagnosed with epilepsy, it felt very isolating.  Losing my independence was difficult, and I felt helpless," said Esteban.  "My journey with epilepsy has taught me so much.  Having VALTOCO has given me peace of mind that I will be prepared for an episode of frequent seizures and being able to help others not feel alone by sharing my story is so rewarding.  I feel more empowered now and have rediscovered my resilience."

"Neurelis is driven to help individuals with epilepsy live their best lives," said Neurelis Founder and CEO Craig Chambliss. "We are proud to join in this event and engage the community whom we advocate for with our work each day."

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.

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