Abstract title

Trial details

Efficacy

Safety

Evaluation of Diazepam Nasal Spray in Patients with Epilepsy Concomitantly Using Maintenance Benzodiazepines: Interim Analysis from a Phase 3, Long-term, Open-label Safety Study

Phase 3, Long-term, Open-label Safety Study in patients with Epilepsy, N=175; diazepam nasal spray 5, 10, 15, or 20 mg (age- and weight-based), with a second dose, if needed, 4 to 12 hours later

Percentage of seizure episodes using a single dose of diazepam nasal spray (proxy for effectiveness): 90.5% vs 92.4% with and without concomitant benzodiazepines

Rates of TEAEs: 79.8% vs 61.5% with and without concomitant benzodiazepines

Serious TEAEs: 30.3% vs 23.1% higher among the patients using concomitant benzodiazepines none were treatment related

Retention rate: 84.1% vs 76.9% with and without concomitant benzodiazepines (Source)

Time to Second Doses in Emergency Seizure Patients Treated With Valtoco  (diazepam nasal spray) Across 24 Hours: Subgroup Results From a Completed Phase 3, Open-label, Repeat Dose Safety Study

Phase 3, open-label in Emergency Seizure Patients; N=174; diazepam nasal spray 5, 10, 15, or 20 mg (age- and weight-based), with a second dose (4, 6, 12, and 24 hours after the initial dose), if needed

A second dose used for 485 (12.0%) seizure episodes

2^nd doses in 4 hours for 152 (3.8%) episodes; in 6 hours for 224 (including prior patients; 5.5%); in 12 hours for 318 (7.8%); and in 24 hours for 485 (12.0%)

Treatment emergent AEs: 82.2%

Treatment-related TEAEs: 18.4%; none were serious

·      46% (26.3%) patients discontinued, with one due to an AE (not considered treatment related) (Source)

Examining the Patient Experience With Diazepam Nasal Spray for Seizure Clusters: Patient-reported Results From an Exit Survey of a Phase 3, Open-label, Repeat Dose Safety Study

Phase 3, Open-label, Repeat Dose Safety Study; N=175; 5, 10, 15, or 20 mg

Most patients were very comfortable doing activities outside the home if they had diazepam nasal spray available (78.8%); 87.9% carried diazepam nasal spray outside the home, and 84.5% were very or extremely comfortable carrying diazepam nasal spray

Compared with diazepam nasal spray, 86.7% were not at all comfortable having rectal diazepam publicly administered

Diazepam nasal spray was primarily administered at the first signs of a seizure (46.2%)

51 patients (77.3%) had a treatment-emergent adverse event

17 patients (25.8%) had a serious TEAE; none were treatment related

4 mild and 1 moderate report of nasal discomfort were assessed as treatment related (Source)

Safety Profile of Valtoco (diazepam nasal spray) in Patients With Epilepsy: Final Results From a Phase 3, Open-Label, 12-Month Repeat Dose Safety Study

Phase 3, Open-Label, 12-Month Repeat Dose Safety Study; N=165

A total of 134 (82.2%) patients had ≥1 TEAE

Serious TEAEs were recorded in 50 (30.7%) patients; none was deemed treatment-related

TEAEs assessed as being possibly treatment-related were seen in 30 patients (18.4%) most commonly nasal discomfort (6.1%)

There were no TEAEs of cardiac or respiratory depression

There were no trends in vital signs or laboratory tests

Of 46 patients who discontinued, 19 withdrew, 11 were lost to follow-up, 1 died (not deemed treatment related), 1 discontinued to due adverse event (not deemed treatment-related) & 14 discontinued for other reasons (Source)