Written on: April 22, 2025 by SprayTM
Neurelis, Inc. announced that the U.S. Food & Drug Administration (FDA) has approved Valtoco (diazepam nasal spray) for short-term treatment of epileptic seizure clusters (also known as “acute repetitive seizures”) that are different from a person’s normal seizure pattern in people two years of age and older.
Valtoco is a proprietary formulation that 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 & CEO.
Eric Segal, Director of Pediatric Epilepsy at Northeast Regional Epilepsy Group and Hackensack University Medical Center, added, “The FDA’s decision to approve Valtoco for use in early childhood highlights the established balanced safety and efficacy profile.
“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, stated Neurelis. 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 Peters, Director, Localization Laboratory, Division of Epilepsy & 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,” Peters added.
Valtoco was previously approved by the FDA to treat episodes of frequent seizures in adults and children six years and older. 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 two years and older who have episodes of frequent seizures.
