Results of the FREEDOM Study (Study 342) presented at the 33rd International Epilepsy Congress (IEC)- In a single-arm study, 63% of patients treated with FYCOMPA 4mg/day achieved seizure freedom at 26 weeks
Eisai Inc. announced results from its FREEDOM Study (Study 342), a Phase III open-label study conducted in Japan and South Korea evaluating the efficacy and safety of FYCOMPA® (perampanel) CIII as monotherapy in new onset or untreated patients with partial-onset seizures (POS). The data was presented at the 33rd International Epilepsy Congress (IEC) taking place in Bangkok, Thailand.
“Through research and development of compounds in our epilepsy franchise, Eisai is committed to shifting the conversation from seizure control to seizure freedom whenever possible. Results from this first investigation of FYCOMPA as monotherapy in patients with partial-onset seizures are an example of this shift,” said Lynn Kramer, MD, Chief Clinical Officer and Chief Medical Officer, Neurology Business Group, Eisai Inc. “Data from the FREEDOM study showed a seizure freedom rate of 63% with a 4mg/day dose of FYCOMPA as monotherapy in newly diagnosed or untreated patients with POS.”
Seizure freedom for partial-onset seizures was achieved in 63% of patients (46/73) treated with FYCOMPA at Week 26 (95% CI: 50.9–74.0). Of those patients who had secondarily generalized seizures 65% (n=31/48) were convulsive seizure free. The most common adverse events (occurring in >5% of patients) out of 68 patients were dizziness (n=18 [26.5%]), nasopharyngitis (n=9 [13.2%]), somnolence (n=9 [13.2%]) and headache (n=7 [10.3%]).