(561) Caregiver Experience With Diazepam Nasal Spray for Seizure Clusters: Caregiver-reported Results From an Exit Survey of a Phase 3, Open-label, Repeat Dose Safety Study

Rationale: Rescue therapy for seizure clusters has generally relied on benzodiazepines. Diazepam nasal spray (Valtoco^®), a proprietary intranasal formulation indicated for acute treatment of seizure clusters in patients with epilepsy aged six years and older, provides improved ease of use compared with rectal diazepam. It is important to assess user perceptions of treatment. Survey responses from caregivers of patients enrolled in a diazepam nasal spray safety study are reported.

Methods:

Patients six to 65 years with seizure clusters were enrolled. Caregivers and patients were trained to administer age- and weight-based doses of 5, 10, 15, or 20 mg. A survey was given to caregivers and patients at study end and was mailed to those who had already concluded or discontinued. Data were collected on ease of use and timing of administration. Patient safety was assessed.

Results: Of 177 subjects enrolled at the October 31, 2019, interim cutoff, 158 received diazepam nasal spray and were evaluated. Eighty-four caregivers of enrolled patients responded to the survey; 98.8% (n=83) were family members (no answer, n=1). Demographically, 85.2% were female and 65.9% were aged 31–50 years (median, 47; range, 29–73). Most caregivers reported prior administration of rectal diazepam rescue medication before starting use of diazepam nasal spray (83.8%).

Administration of diazepam nasal spray was rated as very or extremely easy by 93.8% of caregivers. Caregiver-reported timing of primary administration of diazepam nasal spray was most commonly during a seizure (Figure 1). Use of rectal gel was rated not at all easy by 64.3% in comparison to diazepam nasal spray. Most caregivers carried diazepam nasal spray outside the home (97.6%) and were extremely or very comfortable (89.6%) using diazepam nasal spray in a public setting. This compares to 87.0% who were not at all comfortable using rectal gel. The majority of caregivers reported they could return to their daily activities within an hour after administration of diazepam nasal spray (59.5%; Figure 2). In cases where both patient and caregiver responded to the survey (n=35), paired responses tended to be similar overall.
Of patients these caregivers assisted, 76 had diary data (90.5%). Adverse events (AEs) occurred in 61 (80.3%); 26 (34.2%) had a serious AE, with none evaluated to be treatment-related. No patients discontinued due to an AE.

Conclusions: Results from a survey of caregivers from the Phase 3 diazepam nasal spray safety study show that they administered diazepam nasal spray primarily during seizures. These caregivers reported that diazepam nasal spray was easier to use than rectal gel, and they could return to daily activities quickly after administering diazepam nasal spray, most within an hour. For individual patients, caregiver and patient ratings were similar. The safety profile in these patients was consistent with diazepam, with no discontinuations due to AEs.

Funding: Please list any funding that was received in support of this abstract.: Neureils, Inc.
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