#United States #San Diego #FDA Approval #Neurelis #VALTOCO

Neurelis Gains FDA Approval for VALTOCO (Diazepam Nasal Spray)

Neurelis, Inc., a California-based neuroscience company, has achieved a significant milestone in pediatric epilepsy management with the recent FDA approval of VALTOCO® (diazepam nasal spray). The FDA cleared VALTOCO for the short-term treatment of seizure clusters in children aged two to five years. This innovative intranasal formulation is specifically designed to address acute repetitive seizure episodes that differ from the individual's usual seizure activity, marking a critical advancement in therapeutic options for young patients.

Addressing Unmet Needs in Pediatric Care

Approximately 3.4 million individuals in the United States are living with epilepsy, including an alarming 400,000 children. For many of these children, everyday life can be severely disrupted by frequent episodes of seizures. Traditional treatments often require invasive and less convenient methods, leading to challenges in administering timely care to children. The introduction of VALTOCO minimizes these complications, providing a noninvasive option that can be administered at any moment, even during active seizures.

Neurelis' innovative formulation leverages a proprietary absorption enhancement technology known as INTRAVAIL®, which facilitates effective delivery of diazepam through the nasal membrane. This method not only enhances patient compliance but also ensures rapid onset of action—an essential factor in managing acute seizures where every second counts.

Safety and Clinical Support

The FDA's decision is significantly backed by clinical studies demonstrating VALTOCO's safety and pharmacokinetics. Presentations at the 53rd Annual Child Neurology Society Meeting and the Annual American Epilepsy Society Meeting highlighted the positive outcomes and ease of administration associated with the use of this nasal spray.

Craig Chambliss, the CEO and Founder of Neurelis, expressed gratitude toward those who participated in the clinical trials, stating that their contributions have been pivotal in making this medication accessible to families in need. Medical professionals echo this sentiment, noting that VALTOCO's approval fills an important void in pediatric epilepsy treatment. Dr. Eric Segal commented on the product's established safety and efficacy, emphasizing how it addresses a substantial unmet need for caregivers and families struggling with the complexities of seizure management.

Implications for Families

For caregivers of children with frequent seizures, the approval of VALTOCO brings hope and improvement in the quality of life. Dr. Jurriaan Peters highlighted the difficulties caregivers face with traditional rectal administration when stopping seizure episodes and underscored the importance of offering a more manageable alternative. The intranasal treatment, which can be given without the fear of additional discomfort or invasive techniques, stands to change the landscape of pediatric seizure management significantly.

Looking Forward

Neurelis continues to focus on developing products that address serious neurological disorders with high unmet medical needs. With VALTOCO now approved for children as young as two, the company is poised to lead advancements in treatments that enhance the lives of those affected by epilepsy. Parents and caregivers can find more information about VALTOCO at www.valtoco.com.

Furthermore, the company is also researching other therapeutic options, including the exploratory NRL-1004 for acute agitation and NRL-1049, focusing on cerebral cavernous malformations. These developments further illustrate Neurelis’ commitment to enhancing therapeutic care across a range of neurological conditions.

Conclusion

The approval of VALTOCO marks a revolutionary step forward in treating seizure clusters in young children. With its rapid onset and noninvasive administration, it is a significant addition to the arsenal of seizure management strategies. Families facing the challenges of epilepsy now have a more effective and user-friendly option available, thanks to the tireless efforts of Neurelis and the commitment of the healthcare community to improve pediatric patient outcomes.