San Diego— Neurelis, Inc. announced today that the U.S. Food and Drug Administration (FDA) has approved VALTOCO® (diazepam nasal spray) for immediate treatment of seizure clusters in children aged 2 to 5, expanding access to the only intranasal formulation of diazepam approved for this age group.
VALTOCO is now approved for patients aged 2 and older who experience seizure clusters, also known as acute repetitive seizures, that deviate from their usual seizure pattern. The medication uses INTRAVAIL®, a proprietary absorption enhancement technology, to enable fast and noninvasive intranasal delivery of diazepam. The FDA had previously granted VALTOCO orphan drug exclusivity, recognizing it as clinically superior to rectal diazepam gel.
“This milestone reflects the dedication of our research team and the courage of the patients and families who participated in our clinical studies,” said Craig Chambliss, CEO and Founder of Neurelis. “We’re proud to expand access to an immediate-use treatment option for young children living with epilepsy.”
Experts say the approval fills a critical gap in pediatric epilepsy care. Dr. Eric Segal, Director of Pediatric Epilepsy at Hackensack University Medical Center, noted that VALTOCO’s safety and efficacy profile makes it a much-needed option for families. “This is a meaningful step forward in improving quality of life for children with epilepsy,” he said.
Roughly 3.4 million people in the U.S. have epilepsy, including around 400,000 children. While daily medication helps many manage the condition, some continue to experience dangerous seizure clusters. Until now, rectal administration has been the standard emergency treatment—often posing emotional and logistical challenges for caregivers.
Dr. Jurriaan Peters of Boston Children’s Hospital emphasized the clinical value of the new nasal spray: “Being able to administer diazepam intranasally, even during an active seizure, is a game-changer for families and caregivers. It eliminates the difficulties and invasiveness of traditional methods, especially in young children.”
The approval of VALTOCO for younger patients marks a significant step forward in broadening treatment access for children with epilepsy, offering a faster, less intrusive method to stop seizure clusters when every second counts.
