The following article is part of conference coverage from the 2019 American Academy of Neurology Annual Meeting (AAN 2019) in Philadelphia, PA. Neurology Advisor’s staff will be reporting breaking news associated with research conducted by leading experts in neurology. Check back for the latest news from AAN 2019.
PHILADELPHIA — Diazepam nasal spray, (Valtoco™; Neurelis, Inc.) is safe and well tolerated in patients with epilepsy who experience frequent breakthrough or acute repetitive seizures, according to research presented at the 2019 American Academy of Neurology Annual Meeting, held May 4-10, 2019, in Philadelphia, Pennsylvania.
In this interim analysis, investigators assessed the long-term safety of diazepam after repeat doses administered to patients with epilepsy who experienced frequent breakthrough seizures or acute repetitive seizures over 12 months. Doses (5 mg, 10 mg, 15 mg, or 20 mg) were based on age and body weight and were modified as needed; participants documented time and duration of seizures in patient diaries, along with any outcome events.
The safety population included 109 patients who received at least 1 dose of diazepam. A total of 1585 seizure episodes were treated with diazepam over the study period. In 1457 (92%) episodes, a single dose of diazepam was adequate to stop the seizure.
Overall, 67 patients reported at least 1 adverse event, and 19 experienced adverse events that were considered treatment-related. The most frequent treatment-related adverse events were nasal discomfort, epistaxis, and headache. Only 18 patients reported adverse events that were considered serious; none of those were considered treatment-related.
The investigators suggest that these findings demonstrate the safety and tolerability of diazepam nasal spray to treat patients with epilepsy who experience frequent breakthrough seizures. Few adverse events were related to treatment, and none were considered serious.
Disclosure: Multiple authors disclosed affiliations with pharmaceutical companies. See the reference for complete disclosure information.
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Sperling M, Hogan R, Biton V, Tarquinio D, Carrazana E. A 12-month, open-label, repeat-dose safety study of Valtoco™ (NRL-1 diazepam nasal spray) in patients with epilepsy: interim report. Presented at: 2019 American Academy of Neurology Annual Meeting; May 4-10, 2019; Philadelphia, PA. Abstract P1.5-028.