Analysis of Psychiatric Treatment-Emergent Adverse Events (TEAEs) in Two Phase III Conversion-to-Eslicarbazepine Acetate (ESL) Monotherapy Trials (P5.270)

Objective: To examine the frequency of psychiatric TEAEs in two conversion-to-ESL monotherapy trials. Background: Antiepileptic drugs (AEDs) may cause adverse psychiatric effects. ESL is a once-daily oral AED for partial-onset (focal) seizures (POS). Psychiatric TEAEs were infrequent in trials of adjunctive ESL, but have not been evaluated in conversion-to-ESL monotherapy trials. Design/Methods: Data were pooled from two Phase III randomized, dose-blind, conversion-to-ESL monotherapy trials (093–045 and −046) in adults (16─70 years) with POS uncontrolled by 1–2 AEDs. Following an 8-week baseline period, eligible patients were randomized 2:1 to ESL 1600mg or 1200mg once daily for 18 weeks (2 weeks titration, 6 weeks baseline AED-taper, 10 weeks monotherapy). The pooled intent-to-treat population (all randomized patients receiving ≥1 ESL dose; ESL 1600mg, n=242; ESL 1200mg, n=123) was used for all analyses. Psychiatric and depression/suicidality TEAEs were identified (categorized using the Medical Dictionary for Regulatory Activities, v13.1). Suicidality was assessed using the Columbia-Suicide Severity Rating Scale (C-SSRS). Results: Psychiatric TEAE incidence was similar between doses (ESL 1600mg, 15.3%; ESL 1200mg, 17.9%). Insomnia (4.9%) and anxiety (3.6%) were the most frequently reported psychiatric TEAEs; other psychiatric TEAEs were each reported in Conclusions: Psychiatric TEAE incidence was Study Supported by: Sunovion Pharmaceuticals Inc. Disclosure: Dr Harden has nothing to disclose. Dr. Salpekar has received research support from Lundbeck. Dr. Loring has received personal compensation for consulting, serving on a scientific advisory board, speaking, or other activities with NeuroPace. Dr. Loring has received personal compensation in an editorial capacity for Epilepsia and Neuropsychology Review. Dr. Loring has received research support from Medtronic. Dr. Grinnell has received personal compensation for consulting, serving on a scientific advisory board, speaking, or other activities with Employment: Sunovion Pharmaceuticals Inc. Dr. Cantu has received personal compensation for consulting, serving on a scientific advisory board, speaking, or other activities with Employment: Sunovion Pharmaceuticals Inc. Dr. Cheng has received personal compensation for consulting, serving on a scientific advisory board, speaking, or other activities with Employment: Sunovion Pharmaceuticals Inc. Dr. Blum has received personal compensation for consulting, serving on a scientific advisory board, speaking, or other activities with Employment: Sunovion Pharmaceuticals Inc.