FDA Approves Diazepam Nasal Spray for Treatment of Seizure Clusters in Pediatric Patients
The drug is approved for the short-term treatment of acute repetitive seizures, also known as seizure clusters, which differ from a patient’s normal seizure pattern.
The FDA approved diazepam nasal spray (Valtoco) for the short-term treatment of acute repetitive seizures, also known as seizure clusters, which differ from a patient’s normal seizure pattern. The nasal spray is indicated for patients 2 years and older.1
The drug is approved for the short-term treatment of acute repetitive seizures, also known as seizure clusters, which differ from a patient’s normal seizure pattern. | Image Credit: Syda Productions - stock.adobe.com
"The FDA's decision to approve Valtoco for use in early childhood highlights the established balanced safety and efficacy profile," Eric Segal, MD, director of pediatric epilepsy at Northeast Regional Epilepsy Group and Hackensack University Medical Center, said in a news release.1 "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."
The approval was based on data from the phase 1/2a clinical study that evaluated the safety and pharmacokinetics of the drug, showing that it is safe and effective with easy administration for episodes of frequent seizures. Investigators included patients aged 2 to 5 years with epilepsy and seizure clusters in the open-label, single-dose study with a 180-day safety period. The doses were based on the patient’s weight, and caregivers were supplied with the nasal spray to use as needed for the immediate treatment of seizure clusters. Patients kept a diary of seizures and dose administration and returned to the site on days 30, 90, and 180.1,2
Thirty-five patients were enrolled, with 31 completing the 180-day safety period. The mean age was 3.9 years, and a total of 299 doses were administered. A total of 24 patients experienced a treatment-emergent adverse event (AE), with 10 patients experiencing serious AEs, but none were treatment related. Treatment-related AEs were reported in 7 patients. Only 1 patient experienced reparatory depression, but it was not considered treatment related. No treatment-related AEs led to discontinuation or death, according to the study investigators.1
Previously, in an additional study (NCT02721069), investigators found that the most common treatment-related adverse events included nasal discomfort, headache, dysgeusia, epistaxis, and somnolence. Only 7.9% of patients showed nasal irritation, and the investigators established that the nasal spray was generally safe and comparable to the established profile of rectal diazepam. A second dose was only used for 12.6% of seizure clusters, according to the investigators.3
"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," Jurriaan M. Peters, MD, PhD, director of the localization laboratory in the division of epilepsy and clinical neurophysiology at Boston Children's Hospital, said in a news release.1 "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."
READ MORE: Neurology Resource Center
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