Abstracts

Rationale:
Ideal rescue treatments for patients with epilepsy should be easy to access and administer; therefore, it is important to assess user perceptions of these treatments. Diazepam nasal spray (Valtoco®), a proprietary intranasal formulation indicated for acute treatment of seizure clusters in patients with epilepsy aged 6 years and older, is designed to be a rapid, noninvasive, and socially acceptable route of administration. Patient responses to a survey from a phase 3 safety study of diazepam nasal spray are reported.
Method:
The safety study of diazepam nasal spray enrolled patients 6 to 65 years with seizure clusters. Patients and caregivers were trained to administer age- and weight-based doses of 5, 10, 15, or 20 mg. A survey was given to patients and caregivers at study end and was mailed to those who had already completed or discontinued the study. Data were collected on comfort using diazepam nasal spray outside the home, timing of administration and return to their usual selves, and comfort of use compared with rectal diazepam. Safety was assessed.
Results:
Of 177 subjects enrolled at the October 31, 2019, interim cutoff, 158 received diazepam nasal spray (safety population); 66 responded to the survey (Table). On the survey, 27 patients reported self-administering diazepam nasal spray. Many patients reported past use of rectal diazepam rescue medication prior to starting diazepam nasal spray (48%, n=32). Most patients responded that they 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% found it very or extremely comfortable to carry diazepam nasal spray with them. Diazepam nasal spray was primarily administered at the first signs of a seizure (46.2%). After administration, 37.5% of patients responded that they returned to their usual selves within 30 minutes, and by 60 minutes, a total of 59.4% had returned to their usual selves (Figure). Compared with diazepam nasal spray, 86.7% were not at all comfortable to have rectal diazepam administered in public; 83.9% would prefer using diazepam nasal spray exclusively going forward. In the 66 patients, 51 (77.3%) had a treatment-emergent adverse event (TEAE); 17 (25.8%) had a serious TEAE (≥ 2 patients: seizure [13.6%], pneumonia [4.5%]), none of which were considered treatment related. No patients discontinued because of a TEAE. Four mild and 1 moderate report of nasal discomfort were all assessed as treatment related.
Conclusion:
This survey from the phase 3 safety study of diazepam nasal spray shows that patients were comfortable with diazepam nasal spray outside the home, returned to their usual selves quickly after administration, and were more comfortable being treated in public than with rectal diazepam. The safety profile in these patients was consistent with diazepam, with no discontinuations due to TEAEs and only mild or moderate transient nasal discomfort.
Funding:
:Neurelis, Inc.