To evaluate the impact of a patient’s history of seasonal allergies on the safety and effectiveness of NRL-1 (Valtoco^®), a diazepam nasal spray formulated with the absorption enhancer Intravail A3, administered as a rapid, non-invasive, and socially acceptable rescue medication in patients with epilepsy.

An interim analysis of the ongoing, Phase 3, open-label study evaluating safety/tolerability of NRL-1 included adults and children/adolescents with epilepsy having bouts of seizures despite a stable antiepileptic regimen. Administration of NRL-1 5, 10, 15, or 20 mg was based on patient weight, with a second dose, if needed, 4 to 12 hours later. Safety was assessed. Data were obtained for patients with or without a history of seasonal allergies.

Of the overall population (n=132), 27 patients (20.5%; 6?53 years old; 37.0% female; 70.4% white) had medical histories including seasonal allergies (n=21 [77.8%]), rhinitis (n=4 [14.8%]), allergy/chronic sinus infection (n=1 [3.7%]), or respiratory allergies (n=1 [3.7%]). One patient’s allergies were not ongoing. Patients with allergy history experienced 428 seizure episodes treated with NRL-1; 14 episodes (3.3%) required a second dose. Nineteen patients with a history of allergy (70.4%) had treatment-emergent adverse events (TEAEs); 2 (7.4%) had treatment-related AEs (TRAEs). Among patients without allergies (n=105), 1838 seizure episodes were treated with NRL-1; 177 episodes (9.6%) required a second dose. Seventy-two patients (68.6%) had TEAEs; 20 (19.0%) had TRAEs.

In this analysis, seasonal allergies did not appear to influence need for a second dose of NRL-1. For patients with and without allergies, repeated dosing of NRL-1 diazepam nasal spray demonstrated a similar safety/tolerability profile.