Diazepam Nasal Spray for Acute Treatment of Seizure Clusters Easy to Use and Maintained Quality of Life
**This article was updated on April 13, 2022 to correct an error regarding the relative bioavailability of diazepam nasal spray (Valtoco; Neurelis, San Diego, CA) compared with other formulations of diazepam.
New data from the clinical development program for diazepam nasal spray (Valtoco), approved for treatment of seizure clusters in people age 6 years or more, show the treatment is easy to use and maintained quality of life. In the clinical development program, as requested by the Food and Drug Administration (FDA), 4 pharmacokinetic and a 12-month long-term phase 3 safety study (NCT02721069) were conducted.
Based on patient reported use of diazepam nasal spray via a seizure diary, treatment occurred within a median of 2 minutes. The majority of adult participants who self-administered diazepam nasal spray and caregivers reported it was extremely or very easy to use. Caregivers who administered the spray were age 29 to 73 years and the youngest person to self-administer diazepam nasal spray was age 11 years.
Using the validated Quality of Life in Epilepsy questionnaire, adults treated with diazepam nasal spray had less worry over seizures and improved social functioning. Other aspects of quality of life were maintained over the course of the study.
Enrique Carrazana, MD, chief medical officer of Neurelis said, “This available treatment formulation is easy to use with few adverse events and can provide acute control of seizure clusters and improve quality of life for patients and their families. Our new data add to the well-established body of evidence for Valtoco, and we are pleased to bring this treatment to improve health outcomes for people with treatment-refractory epilepsy who need acute rescue medications.”
During the long-term safety study, which enrolled 175 patients, 163 individuals were dosed and a total of 3,853 seizure clusters were treated. The majority of seizure clusters (87%) were successfully treated with only 1 dose needed in 24 hours. A second dose was required for 13%, usually administered between 4 and 24 hours after the first treatment. However, as per study protocol, participants were able to administer a second dose sooner than 4 hours and did so for 4% of the treated seizure clusters.
This formulation of diazepam nasal spray has 97% bioavailability compared with intravenous diazepam and 2- to 4-times less variable delivery of dosing compared with rectal diazepam gel.
Treatment-emergent adverse events occurred in 4% of participants and included transient somnolence, headache, and nasal irritation. No differences in the safety profile were observed when a second treatment was administered whether the second dose was given later than or within 4 hours of the first dose.
The study results are being presented at American Academy of Neurology Annual Meeting 2022, April 2 to 7 in Seattle, WA and virtually April 24 to 26.