“This medication has been shown to be efficacious [in epilepsy], but the route of administration isn’t ideal, and so the idea to have this as a nasal spray is a real help.”

Recent interim analysis of a long-term safety study of intranasal diazepam (Valtoco, Neurelis) in more than 100 patients with epilepsy showed that the therapy was safe and well-tolerated in those with frequent breakthrough seizures. In total, only 17.4% (n = 19) of patients administered at least one 5-, 10-, 15-, or 20-mg dose experienced an adverse event (AE) deemed related to the study drug.

The most frequent AEs related to the therapy were nasal discomfort (6.4%; n = 7), and epistaxis, headache (8.2%; n = 4). In total, 67 patients reported an AE, and 18 patients had 30 serious AEs, none of which were treatment-related. The data were presented at the 2019 American Academy of Neurology Annual Meeting in Philadelphia, Pennsylvania. Additionally, a single dose of medication was determined to be adequate for seizure control in 1457 of 1585 seizure episodes (92%).

R. Edward Hogan, MD, director, adult epilepsy center, and professor of neurology, Washington University in St. Louis, told NeurologyLive that the therapy has shown great success thus far in well-conducted clinical trials and that its intranasal formulation offers a great advantage over the traditional rectal administration. To find out more about diazepam and what it offers patients and physicians, NeurologyLive spoke with Hogan in an interview.
REFERENCE
Sperling M, Hogan RE, Biton V, et al. A 12-month, open-label, repeat-dose safety study of Valtoco ™ (NRL-1, diazepam nasal spray) in patients with epilepsy: Interim report. Presented at: American Academy of Neurology Annual Meeting; May 4-9, 2019; Philadelphia, PA. Poster P1.5-028.