Diazepam Nasal Spray Treatment Increases Time Interval Between Seizure Clusters

In post hoc analysis of a repeat dose study (NCT02721069), diazepam nasal spray (Valtoco; Neurelis, San Diego, CA) was shown to have increased the times between seizure clusters in individuals with epilepsy.

In this analysis, data from 4 periods of 90 days over the course of 12 months were analyzed. The time between seizure clusters doubled from 12.2 days in period 1 to 25.7 days (nominal P<.01) in participants treated with diazepam. 

Most participants successfully treated their seizure clusters with a single dose. Over the 12-month study, only 11.5% of the participants age 6-11 years and 12.9% of those age 12-65 years had a second dose of diazepam administered within 24 hours of the first dose. These results further support that diazepam nasal spray provides protection for 24 hours. The study retention rate was 76% in both age groups.

"VALTOCO and other rescue therapies play a critical role in treatment plans for people with poorly controlled epilepsy and seizure clusters," said Adrian Rabinowicz, MD, SVP Clinical Development and Medical Affairs. "These latest SEIVAL results lend themselves to a hypothesis that intermittent treatment should be further studied to investigate potential biological and behavioral changes that may impact the natural course of seizure clusters."

"We continue to explore the robust data set generated by the VALTOCO phase 3 study in people with uncontrolled epilepsy that experience episodes of frequent seizure activity," said Sunita Misra, MD, senior medical director. "This data has the potential of evolving the landscape of care for epilepsy patients in the future and we are incredibly encouraged by the exploratory analysis generated thus far."

Nasal irritation rates were low and transient, and no serious treatment-related adverse events occurred, including respiratory depression.

These data were presented at the 2nd North American Epilepsy Congress (NAEC) held virtually May 5-8, 2022.