FDA Approves Neurelis' Seizure Nasal Spray

The U.S. Food and Drug Administration (FDA) has granted approval for Neurelis' diazepam nasal spray, known as Valtoco, as a short-term remedy for acute repetitive seizures, also termed seizure clusters, in individuals aged two years and older. Valtoco utilizes a unique transmucosal absorption enhancement technology called Intravail, which enables the noninvasive delivery of diazepam intranasally.

This innovative technology aids in the effective delivery of proteins, small-molecule drugs, and peptides. Previously, the FDA acknowledged the superiority of Valtoco’s intranasal formulation over the traditional rectal gel form of diazepam by awarding it orphan drug exclusivity designation. This recognition underscores the advancement Valtoco represents in seizure management.

In the United States, approximately 3.4 million adults and 400,000 children are affected by epilepsy, many experiencing acute repetitive seizures. During its Phase I/IIa clinical trials, Valtoco demonstrated both its efficacy and safety when administered nasally to subjects two years and older.

Neurelis, the company behind this advancement, is committed to developing and marketing therapies for epilepsy and other neurological disorders with unmet medical needs. However, it is important to note that the nasal spray is not approved for use in infants or neonates. The presence of benzyl alcohol in preserved medications poses significant risks to these populations, potentially causing fatal side effects such as gasping syndrome. This syndrome is characterized by metabolic acidosis, central nervous system depression, and gasping respiratory patterns.

Craig Chambliss, CEO and founder of Neurelis, expressed deep appreciation for the individuals and families involved in the clinical study, acknowledging their vital role in making Valtoco a reality. Their participation was instrumental in expanding access to this immediate-use medication, which is crucial for halting episodes of frequent seizures.

Valtoco's approval represents a significant stride forward in providing patients and caregivers with a user-friendly, rapid-response treatment option. The nasal spray's design addresses the need for a noninvasive, efficient method of delivering medication during seizure emergencies. This development not only enhances the quality of life for those affected by seizure clusters but also supports caregivers in administering treatment more swiftly and effectively.

The introduction of Valtoco is a testament to Neurelis' dedication to addressing gaps in epilepsy care. By focusing on creating novel solutions for neurological conditions, Neurelis continues to pave the way for advancements that cater to patients’ specific needs. As the company moves forward, the approval of Valtoco sets a precedent for future innovations in the treatment of seizure disorders, highlighting the potential for technology-driven solutions to transform patient care.

In summary, the FDA's approval of Valtoco marks a pivotal moment in epilepsy treatment, offering a promising new option for managing acute repetitive seizures through innovative nasal spray technology. Neurelis’ commitment to addressing unmet medical needs ensures that patients have access to effective, noninvasive treatments that make a tangible difference in managing their condition.