To assess the long term safety of diazepam after repeat intranasal doses of Valtoco™ (NRL-1, diazepam nasal spray), formulated with Intravail® A3, administered to patients with epilepsy who experience frequent breakthrough seizures or Acute Repetitive Seizures (ARS), over 12-months.

In this repeat dose, open-label trial, Valtoco was administered as needed to treat bouts of diagnosed seizures over a 12-month period of time.  Doses were defined as 5 mg, 10 mg, 15 mg, or 20 mg based on the subject’s age and body weight, and were modified by the investigators as needed.  Patients diaries documented time and duration of seizures and outcome.

Of the 121 patients enrolled to date in this interim analysis, 109 patients (14 < 12 years of age) received at least one dose of Valtoco and were included in the safety population.  There was a total of 1585 seizure episodes treated with Valtoco in 109 patients in the safety population (1 to >40 doses).  

A single dose was adequate for seizure control in 92% (1457) of seizure episodes.

Overall, 67 out of 109 patients (61.5%) had at least one adverse event (AE).  Nineteen patients (17.4%) had AEs that were considered treatment-related by the Investigator. The most frequent treatment-related events were nasal discomfort (7 patients, 6.4%), and epistaxis, headache (4 patients, 8.2%).  Of the 67 patients experiencing AEs, 18 patients had 30 AEs that were considered serious, none of which was considered treatment-related by the Investigators.

Overall, this study demonstrates that Valtoco is safe and well tolerated in subjects with epilepsy who have frequent breakthrough seizures.  Relatively few of the reported AEs were treatment related, and these were generally mild or moderate in severity. No SAEs were attributable to Valtoco.