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Neurelis Announces FDA Approval for Immediate Use Seizure Medication Valtoco (diazepam nasal spray) in Ages 2 to 5 Years

San Diego, CA – April, 16, 2025 – Neurelis, Inc., today announced that the U.S. Food and Drug Administration (FDA) has approved Valtoco (diazepam nasal spray) for short-term treatment of seizure clusters (also known as “acute repetitive seizures”) that are different from a person’s normal seizure pattern in people 2 years of age and older. Valtoco is a proprietary formulation which utilizes an absorption enhancement technology, INTRAVAIL®, to enable the noninvasive, enhanced intranasal delivery of diazepam. The intranasal formulation of Neurelis’ Valtoco was previously recognized by the FDA as clinically superior to the rectal gel formulation of diazepam resulting in its orphan drug exclusivity designation.

“We are so grateful for all those who participated in the clinical study to enable Valtoco to reach this milestone, especially the patients and families whose participation in the trial helped expand access to a unique immediate-use medication to help stop an episode of frequent seizures,” said Craig Chambliss, Neurelis Founder and CEO.

“The FDA’s decision to approve Valtoco for use in early childhood highlights the established balanced safety and efficacy profile,” commented Eric Segal, MD, Director of Pediatric Epilepsy at Northeast Regional Epilepsy Group and Hackensack University Medical Center. “Valtoco fills a large unmet need for children with seizures and their families. I am hopeful that this product will improve quality of life for this specific population.”

Approximately 3.4 million people in the U.S. have epilepsy, including 400,000 children. While chronic epilepsy can be controlled by medications, some patients are at risk of episodes of frequent seizures, or acute repetitive seizures.

“For children who have episodes of frequent seizures, the current standard of care requiring rectal administration of medication to stop a seizure can be a significant challenge for caregivers and children alike,” added Jurriaan M Peters, MD, PhD, Director, Localization Laboratory, Division of Epilepsy and Clinical Neurophysiology, Boston Children’s Hospital, and Associate Professor in Neurology at Harvard Medical School. “Approval of an immediate-use intranasal diazepam treatment that can be given at any time, even while a child is actively seizing, in this young age group is an important advance for the epilepsy community.”

Data from the phase 1/2a clinical study evaluating safety and pharmacokinetics demonstrated that Valtoco is safe and effective with easy nasal administration for patients aged 2 years and older who have episodes of frequent seizures. The company presented data on the study at the 53rd Annual Child Neurology Society Meeting in November 2024 in San Diego and Annual American Epilepsy Society Meeting in December 2024 in Los Angeles.

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:

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.

NEURELIS, Valtoco, MYNEURELIS, PERSONALIZED SUPPORT FOR PATIENTS AND CARE PARTNERS, and the NEURELIS, Valtoco, and MYNEURELIS logos are trademarks or registered marks of Neurelis, Inc.

Intravail, ProTek, and Hydrogel, and the Intravail, ProTek, and Hydrogel logos are trademarks or registered trademarks of Aegis Therapeutics, LLC. Aegis Therapeutics, LLC, is a wholly-owned subsidiary of Neurelis, Inc.

Tosymra is a registered trademark of Dr. Reddy’s Laboratories Limited.

Imitrex is a registered trademark of the GlaxoSmithKline group of companies.

Neffy is a trademark of ARS Pharmaceuticals, Inc.

Source: Neurelis, Inc.

Posted: April 2025

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