WOODCLIFF LAKE, N.J., Dec. 2, 2015 /PRNewswire/ -- Eisai Inc. announced today that 21 posters highlighting perampanel data and an interim analysis from the first and largest caregiver burden study in epilepsy will be presented at the 69th Annual American Epilepsy Society Meeting, taking place December 4-8, 2015, in Philadelphia, PA.
“We are pleased to present these data to the scientific community,” said Lynn Kramer, MD, President of the Neuroscience and General Medicine Product Creation Unit and Chief Clinical Officer of Eisai Product Creation Systems, Eisai’s research and development organization. “Eisai is committed to advancing epilepsy care and making contributions to help address the diversified needs of epilepsy patients and their families as part of its human health care (hhc) mission.”
The following perampanel data will be presented during poster sessions on Saturday, December 5th through Monday, December 7th. Highlights include the following:
| Poster Title | Poster Number |
| Saturday, December 5th, 2015, 12:00-2:00pm | |
| Long-Term Perampanel Treatment in Patients with Drug-Resistant Partial Seizures: > 75% Responders and Seizure-Free Status
| 1.196 |
| Effect of Adjunctive Perampanel in Pediatric Subjects with Epilepsy: Preliminary Safety and Efficacy Results from Study 232
This analysis reports preliminary safety and efficacy findings from an open-label Phase II pilot study of perampanel oral suspension in pediatric subjects aged 2 to <12 years old with epilepsy. | 1.184 |
| Pharmacokinetics of Perampanel in Children with Epilepsy Aged 2-<12 Years
This analysis reports the pharmacokinetics of perampanel as adjunctive therapy in children compared to adolescents. | 1.187 |
| Efficacy of Perampanel by Baseline Seizure Frequency in Patients with Partial Seizures (Phase III Double-Blind Studies)
This post-hoc analysis evaluates the efficacy of perampanel in subjects with drug-resistant partial seizures based on their seizure frequency at the time of enrollment in three Phase III perampanel double-blind studies.
| 1.188 |
| Suicidality Events in Patients with Primary Generalized Tonic-Clonic Seizures (PGTCS): A Review of Study 332
This analysis of a randomized double-blind, placebo-controlled study of subjects 12 years of age or older with uncontrolled PGTCS reviews suicidal behavior and ideation using adverse event reporting and the Columbia Suicide Severity Rating Scale (C-SSRS). | 1.189 |
| Psychiatric and Behavioral Events with Perampanel in Patients with Primary Generalized Tonic-Clonic Seizures (PGTCS): Study 332
This analysis of a randomized double-blind, placebo-controlled study of subjects 12 years of age or older with uncontrolled PGTCS reviews psychiatric and behavioral events using adverse event reporting to further understand perampanel and psychiatric and behavioral events.
| 1.190 |
| Subanalysis by Baseline Antiepileptic Drugs (AEDs): Results from Perampanel Study 332 in Patients with Primary Generalized Tonic-Clonic Seizures (PGTCS)
This sub-analysis evaluates the efficacy and safety of perampanel by baseline antiepileptic drugs in subjects 12 years of age or older with uncontrolled PGTCS and taking 1-3 concomitant antiepileptic drugs. | 1.191 |
| Review of Pregnancy Events in Perampanel Clinical Studies
This review compiles pregnancy data from perampanel clinical studies. | 1.192 |
| Effect of Duration of Epilepsy on Adjunctive Perampanel Treatment in Patients with Drug-Resistant Partial Seizures
This post-hoc analysis reports efficacy results of perampanel adjunctive therapy in subjects with drug-resistant partial seizures stratified by duration of epilepsy.
| 1.193 |
| Analysis of Falls in the Phase III Perampanel Study of Primary Generalized Tonic-Clonic Seizures (PGTCS)
This analysis is a systematic review of reported falls evaluated to establish whether the fall was related to a seizure.
| 1.194 |
| Clinical Laboratory Evaluation and Treatment-Emergent Adverse Events Related to Cardiac, Hepatic and Renal Disorders; Perampanel PGTC Phase III Study This analysis evaluated laboratory tests and treatment-emergent adverse events related to these tests, as well as cardiac-, hepatic- and renal-related treatment-emergent adverse events, in subjects aged 12 years or older enrolled in a primary generalized tonic-clonic seizure Phase III study. | 1.195 |
| Model-Predicted Relationships Between Perampanel Plasma Concentrations and Efficacy for Partial-Onset Seizures (POS) and Primary Generalized Tonic-Clonic (PGTC) Seizures
This analysis of four randomized double-blind, placebo-controlled study of subjects aged > 12 years with idiopathic generalized epilepsy and uncontrolled PGTCS presents equivalent pharmacokinetic/pharmacodynamics (PK/PD) data from patients with partial onset seizures and primary generalized tonic-clonic seizures.
| 1.211 |
| Protein Binding of Perampanel in Human Plasma: Does Protein-Binding Displacement Occur?
These in vitro analyses evaluated the potential for perampanel to act as a displacer and the displacement of perampanel by other commonly used anti-epileptic drugs (phenytoin or valproate) or a highly bound reference drug (warfarin).
| 1.212 |
| Pharmacokinetics of Adjunctive Perampanel in Patients with Partial-Onset Seizures and Primary Generalized Tonic-Clonic (PGTC) Seizures in Idiopathic Generalized Epilepsy (IGE): Pooled Data from Four Randomized, Double-Blind Phase III Studies
This univariate analysis investigated the effect of weight, age, sex, race, liver and renal function markers, dose, seizure type, and presence of concomitant enzyme-inducing antiepileptic drugs (EIAEDs) on the apparent clearance (CL/F) of perampanel.
| 1.214 |
| Budget Impact of Perampanel for Treating Primary Generalized Tonic Clonic Seizures (PGTC) Patients in Addition to Existing Partial-Onset Seizures (POS) Patients in the US To read full press release, please click here. | |
