In RCTs, 352 (16.1%) patients had a psychiatric history (perampanel n=244; placebo n=108); 1835 (83.9%) had no psychiatric history (perampanel n=1325; placebo n=510). Frequency of TEAEs and psychiatric TEAEs depended on perampanel dose. In patients with a psychiatric history, psychiatric TEAEs were observed in 73 (29.9%) and 21 (19.4%) patients with perampanel and placebo, respectively. With perampanel 2 and 4 mg/day, psychiatric TEAEs were less frequent vs placebo (11.1% and 15.4% vs 19.4%, respectively). Most common psychiatric TEAEs with perampanel with psychiatric history were anxiety (5.3%) and insomnia (4.9%). In patients without a psychiatric history, psychiatric TEAEs were observed in 157 (11.8%) and 47 (9.2%) patients with perampanel and placebo, respectively. Most common psychiatric TEAEs with perampanel without psychiatric history were insomnia (2.0%), aggression (2.0%), and anxiety (1.8%).

In OLEx’s, 283/1895 (14.9%) patients had a psychiatric history. Psychiatric TEAEs were observed in 151 (53.4%) and 521 (32.3%) patients with/without a psychiatric history, respectively. The most common psychiatric TEAE was irritability (16.3%/10.4%, with/without psychiatric history).

Psychiatric TEAEs are reported by more patients with a psychiatric history than without, and were dependent on perampanel dose irrespective of previous psychiatric illness. In patients with/without a history of psychiatric illness, perampanel 4 mg/day did not cause an increased incidence of psychiatric TEAEs versus placebo.

Funding: Eisai Inc.