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Clinical Experience in Adults

  • The Phase 3 open-label, single-arm safety study (NCT02721069) evaluated diazepam nasal spray in patients 6–65 years old with epilepsy and seizure clusters
    • The treatment period was 12 months
  • Of 163 patients included in the safety population, 85 were aged ≥18 years
  • 62 adults (72.9%) completed the 12-month treatment period
  • In adults, diazepam nasal spray safety was similar to rectal diazepam
  • 77.6% of adults had ≥1 treatment-emergent adverse event (TEAE)
  • 22.4% of TEAEs were at least possibly related to treatment
  • Serious TEAEs were reported in 25.9% of adults, none were treatment related
  • 1 death and 1 discontinuation due to a TEAE were not treatment related
  • The proportion of seizure clusters treated with 2 doses within 24 hours is a proxy for effectiveness
  • Of 2219 treated seizure clusters in adults, 299 were treated with second doses (i.e., only 1 dose for 86.5% of clusters)
  • In the overall study, rates of TEAEs (15.2%) and treatment-related TEAEs (5.1%) occurring within 1 day of a second dose were low
  • Figure. Low Proportion of Seizure Clusters Administered Second Doses Within 24 Hours of the Prior Dose
  • Shorter time to treatment was associated with faster seizure termination in adults
  • For seizure clusters treated in <5 minutes from seizure onset (n=994), median time from dose to seizure termination was 2 minutes
  • For seizure clusters treated in 5-15 minutes (n=335) and ≥15 minutes (n=238), times to termination were 10 and 20 minutes, respectively
  • Figure. Median Time to Dose Administration and Time to Seizure Termination (1567 observations)
  • Self-administration of diazepam nasal spray was reported by a subgroup of primarily adults (n=27 of 163)
    • Self-administration may empower patients’ independence
  • Quality of Life in Epilepsy (QOLIE) scores were stable or increased (improved) across 365 days
    • Seizure Worry and Social Functioning subscales increased (improved); they may be sensitive to intermittent therapy
  • Figure. Mean QOLIE-31-P Score/Subscores Across 1 year (n = 72)

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  • Seizure action plans (SAPs) are individualized to address seizure emergencies
  • Although emergency plans are common for adults with other conditions, most adults with epilepsy do not have an SAP
  • Seizure action plans may facilitate consistent and appropriate epilepsy management
  • Customizable SAP templates can expedite implementation
  • Figure. Sample Acute Seizure Action Plan
  • Oral tablets and wafers have been used for seizure clusters in adult patients as an alternative to rectal administration
  • However, oral formulations have potential therapeutic barriers
    • Delayed gastrointestinal absorption
    • Aspiration risk
    • First-pass metabolism
    • Mechanical limitations (e.g., clenched jaw, bite risk)
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