Date: 2014-12-08
Type of information: Presentation of results at a congress
phase: 3
Announcement: presentation of results at the 68th American Epilepsy Society (AES) Annual Meeting held from December 5 to 9 in Seattle, Washington
Company: Eisai (Japan)
Product: Fycompa® (perampanel)
Action
mechanism: Fycompa®, a novel chemical entity discovered and developed by Eisai, is a noncompetitive AMPA-type glutamate receptor antagonist. Fycompa is an antiepileptic drug that reduces neuronal hyperexcitation associated with seizures by targeting glutamate activity at postsynaptic AMPA receptors. The agent is currently approved in more than 40 countries and territories, including Europe and the United States, as an adjunctive treatment (once-daily oral dose) of partial-onset seizures and is also being evaluated in a Phase III study (Study 335) in Asia, including Japan.
A Phase III study (Study 332) of the agent as an adjunctive therapy for the treatment of primary generalized tonic-clonic (PGTC) seizures conducted in the United States, Europe and Asia, including Japan, met its primary endpoint, and regulatory applications for an indication expansion of the agent are under review in the United States and Europe. The company plans to submit a regulatory application covering both study 332 and study 335 in Japan in fiscal 2015. Furthermore, Eisai is conducting Phase II studies in Europe and the United States for partial-onset epilepsy in pediatric patients.
Disease: primary generalized tonic-clonic (PGTC) seizures
Therapeutic area: CNS diseases - Neurological diseases
Country:
Trial details:
Latest
news: * On December 8, 2014, Eisai announced that it has presented the results from a Phase III clinical study (Study 332) of its in-house developed antiepileptic drug (AED) Fycompa® (perampanel) in patients with primary generalized tonic-clonic (PGTC) seizures, one of the most severe forms of generalized seizures. The data was presented at the 68th American Epilepsy Society (AES) Annual Meeting held from December 5 to 9 in Seattle, Washington in the United States (Abstract No.: 2389). Study 332 was a double-blind, randomized, placebo-controlled, multicenter, parallel-group study to evaluate the efficacy and safety of adjunctive Fycompa therapy in 164 patients aged 12 years and older with uncontrolled PGTC seizures. In this study, eligible patients receiving one to a maximum of three AEDs were randomized to receive Fycompa or placebo in a 1:1 ratio. The primary endpoints of the study were change in PGTC seizure frequency (percent change from Baseline in PGTC seizure frequency per 28 days) and responder rate (percentage of patients who experienced a 50% or greater reduction in PGTC seizure frequency).* A reduction in PGTC seizure frequency of 76.5% was observed in the Fycompa group, which was statistically significant when compared to a reduction of 38.4% for placebo (p<0.0001). Additionally, the responder rate for Fycompa was 64.2%, which was a statistically significant improvement over the responder rate for placebo of 39.5% (p=0.0019). In addition, in this study which enrolled patients who had been unable to adequately control PGTC seizures with existing AEDs, 30.9% of patients treated with Fycompa were free of PGTC seizures (12.3% for placebo) during the 13 week Maintenance period. Furthermore, the most common adverse events (>10% in the Fycompa arm and greater than placebo) for Fycompa and placebo were, respectively, dizziness (32.1% vs 6.1%), fatigue (14.8% vs 6.1%), headache (12.3% vs 9.8%), somnolence (11.1% vs 3.7%) and irritability (11.1% vs 2.4%).
