Epilepsy digest
American Academy of Neurology - 2021

Epilepsy digest American Academy of Neurology - 2021

UCB Pharma presentations @ AAN: Briviact and Nayzilam

Briviact (brivaracetam) – UCB Pharma

Safety and tolerability of intravenous brivaracetam in patients with epilepsy on concomitant levetiracetam treatment

  • Objective: To assess the safety and tolerability of IV brivaracetam in patients with uncontrolled focal or primary generalized seizures on concomitant levetiracetam
  • Trial details: Phase 3 in epilepsy; N=105; Brivaracetam intravenous infusion and bolus, administered in BID regimen as an adjunctive antiepileptic;
  • Results: TEAEs and drug-related TEAEs in patients treated with IV BRV + LEV were similar to the overall population (TEAEs: 76.3% vs 76.2%; drug-related TEAEs: 65.8% vs 63.8%)
    • One (2.6%) patient on concomitant LEV discontinued due to a TEAE (anxiety)
    • Most common (≥5%) TEAEs in the overall population, somnolence (29.5%), dizziness (14.3%), headache (6.7%), fatigue (5.7%), were reported by 26.3%, 10.5%, 10.5%, and 5.3% IV BRV+LEV-treated patients, respectively
    • The incidence of individual TEAEs classified as psychiatric or potential behavioral disorders was low (≤3%), with no apparent differences between the IV BRV+LEV-treated patients and the overall population
    • Four (10.5%) IV BRV + LEV patients had an injection site-related TEAE (overall: 10.5%)
  • Conclusion: In patients taking concomitant LEV, IV BRV was well tolerated and may be considered a safe additional treatment option in patients with focal seizures unable to receive oral BRV (Source)

Nayzilam (Midazolam) – UCB Pharma

  • Objective: To assess the impact of treatment of seizure clusters (SCs) with one or two midazolam nasal spray (MDZ-NS) doses on the time to return to full baseline functionality (FBF) in patients with epilepsy, over repeated intermittent episodes

Abstract title

Trial details

Results

Return to full baseline functionality after repeated intermittent use of midazolam nasal spray in patients with seizure clusters: Post-hoc analysis of an open-label extension trial

NCT01529034; Phase 3 in patients with seizure clusters, N=175; Intranasal midazolam (MDZ-NS) 5 mg; Post-hoc analysis and treatment satisfaction of open-label extension trial

·         In seizure clusters episodes (SCEs) treated with one or two doses, 97.2% and 94.2% of patients returned to full baseline functionality (FBF) within 24 h of MDZ-NS administration, respectively; the estimated median time was 1.2 h (Q1–Q3: 0.4–2.4) and 1.3 h (0.5–3.5), respectively

·         The profile of return to FBF was generally similar in SCEs treated with one and two MDZ-NS doses, with a slightly higher proportion of patients returning to FBF between 2–6 h after the administration of one MDZ-NS dose (Source)

Treatment satisfaction, anxiety level, and confidence about traveling with midazolam nasal spray in patients with seizure clusters: Phase 3, open-label extension trial

·         Mean change in anxiety level since receiving MDZ-NS (Intranasal Therapy Impact Questionnaire (ITIQ)) improved from 2.5 (standard deviation 2.5) (V1) to 3.5 (2.7) (Last Visit) in patients and from 2.6 (2.5) to 3.6 (2.7) in caregivers and generally improved over repeated MDZ-NS use

·         Proportions of patients and caregivers who answered ‘strongly agree’ or ‘agree’ for confidence about traveling with an intranasal spray was ≥79% throughout and rose from V1–V10 (Source)

IV Brivaracetam (BRV) may be a safe option in patients with focal seizures unable to receive oral BRV; Return to full baseline functionality supports use of repeated intermittent MDZ-NS in patients with seizure clusters

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CI Scientists Remarks:

  • About Seizure clusters: They are broadly defined as acute episodes of consecutive seizures that occur within a short period of time with a patient regaining consciousness during the interictal period
    • Other names for seizure clusters include acute-repetitive seizures (ARS), serial seizures, crescendo seizures, and seizure flurries, which highlight the repetitive nature of the seizures
  • About Briviact (Brivaracetam):
    • In 2016, Briviact was approved in the US as an add-on therapy for adult patients with partial-onset seizures, as monotherapy for adults in 2017, and as monotherapy or adjunctive therapy in patients four years of age and older with partial-onset seizures in 2018
    • In the EU, BRIVIACT is indicated as adjunctive therapy in the treatment of partial-onset seizures with or without secondary generalization in adults, adolescents, and children from 4 years of age with epilepsy
  • About Nayzilam (Midazolam): Approved in 2019, Nayzilam is a benzodiazepine indicated for the acute treatment of intermittent, stereotypic episodes of frequent seizure activity (i.e., seizure clusters, acute repetitive seizures) that are distinct from a patient’s usual seizure pattern in patients with epilepsy 12 years of age and older
  • At AAN 2021, UCB is reporting the latest data on Briviact’s safety and tolerability after long-term treatment in patients with focal seizures. Two abstracts will also highlight data from the open-label ARTEMIS-2 trial for Nayzilam nasal spray for the acute treatment of intermittent, stereotypic episodes of frequent seizure activity that are distinct from a patient’s usual seizure pattern in patients with epilepsy 12 years of age and older

– Dr. Kowndinya, CI Scientists

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