Long term safety of diazepam nasal spray

An interim-analysis of an open-label trial showed that diazepam nasal spray is safe and well tolerated in epilepsy patients with frequent breakthrough seizures or acute repetitive seizures. Adverse events were generally mild or moderate in severity, and mostly unrelated to treatment [1].

Of 121 enrolled patients thus far, 109 were included in the safety analysis. Their median age was 14 years. Diazepam nasal spray was administered as needed to treat bouts of diagnosed seizures over a 12-month period. Doses were 5, 10, 15, or 20 mg based on age and body weight. A total of 1,585 seizure episodes were treated with diazepam nasal spray (1 to >40 doses). A single dose adequately controlled seizures in 92% of seizure episodes. Overall, 67 patients had at least one adverse event. A total of 19 patients had treatment-related adverse events, the most frequent of which was nasal discomfort (n=7); 18 patients had 30 serious adverse events that were not treatment-related.

1. Sperling M,et al. AAN 2019, P1.5-028.



Posted on 30 July 2019