FDA approved VALTOCO® (diazepam nasal spray) for the treatment of seizure clusters in children between 2 and 5 years of age. VALTOCO nasal spray offers quick and easy administration to stop sudden seizure clusters. The INTRAVAIL® system in this product helps increase nasal absorption, which enables rapid seizure control without the need for rectal administration.
The new drug approval has expanded treatment options for families and caregivers who require seizure management solutions according to Craig Chambliss who leads Neurelis as Founder and CEO. He expressed deep gratitude to medical professionals and family members who took part in the clinical trials. The approval represents an important achievement that benefits young epilepsy patients in need of emergency seizure treatment.
Epilepsy affects 3.4 million Americans, among whom 400,000 children are diagnosed with this disease. Daily medication enables most people with this condition to control their seizures, but for some individuals, sudden seizure clusters (back-to-back seizures) require immediate intervention. Repeated seizure activity may prompt patients to seek immediate medical attention.
Medical experts have welcomed the news, according to Dr. Eric Segal, a pediatric epilepsy specialist at Hackensack University Medical Center. Dr. Segal stated that VALTOCO provides crucial medical support for young children with epilepsy who critically need it right now. VALTOCO is an indispensable seizure emergency management since it is easy to use and has demonstrated safety performance for ambulatory or home seizure emergencies.
Dr. Jurriaan Peters from Boston Children’s Hospital expressed high praise for the approval by emphasizing the exceptional advantages of nasal administration during active seizures in children. Emergency seizure treatment is now more manageable and less stressful because of this development, especially during time-sensitive situations.
Results from the phase 1/2a clinical trial assessed safety and pharmacokinetics, showing that VALTOCO was an effective treatment for patients aged 2 years and above who experienced frequent seizure episodes, offering the convenience of intranasal delivery. The company showcased data from the research at the 53rd Annual Child Neurology Society Meeting held in San Diego during November 2024, followed by a presentation at the Annual American Epilepsy Society Meeting in December 2024 in Los Angeles.
VALTOCO functions as a rescue treatment made exclusively for acute seizure clusters, allowing families to use it easily at their homes, schools, and public places. It maintains its mission to produce leading-edge therapies suitable for patients suffering from epilepsy and neurological disorders. The FDA approval positions VALTOCO as a key intervention for pediatric seizure management, providing caregivers with quick, noninvasive emergency care.
References: Neurelis announces FDA approval for immediate use seizure medication VALTOCO® (diazepam nasal spray) in children aged 2 to 5. Neurelis. Published April 16, 2025. https://www.neurelis.com/neurelis-announces-fda-approval-for-immediate-use-seizure-medication-valtoco-diazepam-nasal-spray-in-ages-2-to-5/
