Eisai to Present New Data on Perampanel at the 33rd International Epilepsy Congress

Tokyo, June 28, 2019 /PRNewswire/ -- Eisai Co., Ltd. (headquartered in Tokyo, Japan; President: Haruo Naito; hereinafter referred to as “Eisai”) recently announced that it will present the latest data on its antiepileptic drug perampanel (brand name: Fycompa®) at the 33rd International Epilepsy Congress (IEC 2019). The congress will be held in Bangkok, Thailand, from June 22 to 26, 2019.

At that time, Eisai will deliver two oral presentations during the main report session, covering the final analysis results of the Phase III clinical study (Study 311) on perampanel combination therapy for pediatric epilepsy patients aged 4 to under 12 years. In addition, preliminary analyses from the Phase III clinical study (FREEDOM/Study 342) evaluating the efficacy and safety of perampanel monotherapy in treatment-naïve patients with partial-onset seizures (with or without secondary generalization) in Japan and South Korea will be presented through 12 posters.

Perampanel is a first-in-class, once-daily oral antiepileptic tablet developed by Eisai’s Tsukuba Research Center. The oral suspension formulation of this drug has been approved for marketing and sale in the United States and Europe. As a highly selective, non-competitive AMPA receptor antagonist, perampanel reduces neuronal hyperexcitability by targeting glutamate activity at AMPA receptors on the postsynaptic membrane. Currently, perampanel is approved worldwide as adjunctive therapy for partial-onset seizures (with or without secondary generalization) and primary generalized tonic-clonic seizures in patients aged 12 years and older with epilepsy. Additionally, the drug has been approved in the United States as monotherapy and adjunctive therapy for partial-onset seizures (with or without secondary generalization) in patients aged 4 years and older with epilepsy.

Eisai has designated the neurological field, including epilepsy, as a key therapeutic area for its pharmaceuticals. The company is committed to promoting perampanel worldwide, with the corporate mission of liberating more patients suffering from epilepsy from the burden of seizures. Eisai strives to meet the diverse needs of patients with epilepsy and their families, thereby enhancing their well-being.

Oral Presentation:

Report Number and Scheduled Report Date
(Local Time)

Abstract Title

Platform Conference: Treatment
Oral Presentation Time:
6Month24Monday15:30-15:45

Perampanel as Adjunctive Therapy for Partial-Onset Seizures (POS) in Children (Aged 4 to <12 Years) or Primary
Generalized Tonic-Clonic Seizure
Safety and Efficacy in Patients with Primary Generalized Tonic-Clonic Seizures (PGTCS): Final Results of the 311 Core Study

Platform Meeting: Treatment
Oral Presentation Time:
6Month24Monday15:45-16:00

Enzyme-Inducing Antiepileptic Drugs (EIASDs) in Perampanel Adjunctive Therapy for Epilepsy in Children Aged 4 to <12 Years
Impact on Safety and Efficacy in Patients with Partial-Onset Seizures (POS): The 311 Core Study’s
Final Results

Poster Display

Display Number and Scheduled Display Date
(Local Time)

Abstract Title

Poster # p125
Poster Exhibition: Pharmacotherapy1
Poster Presentation Time:
6Month23Sunday10:00-17:00

Perampanel as First-Line Monotherapy for Patients with Focal Seizures (with or without Secondary Generalization): A Multicenter, Open-Label, Prospective Cohort Study

Poster # p215
Poster Exhibition: Pediatric Epilepsy1
Poster Presentation Time:
6Month23Sunday10:00-17:00

Perampanel as Adjunctive Therapy in Pediatric Patients with Epilepsy: Population Pharmacokinetic (PK) and Exposure-Response Analysis

Poster # p317
Poster Exhibition: Pharmacotherapy2
Poster Presentation Time:
6Month24Monday10:00-17:00

Perampanel does not exacerbate myoclonic and absence seizures

Poster # p328
Poster Exhibition: Pharmacotherapy2
Poster Presentation Time:
6Month24Monday10:00-17:00

Perampanel in Real-World Clinical Care of Patients with Epilepsy: Retrospective Phase IV Study 506 (PROVE Study)

Poster # p329
Poster Exhibition: Pharmacotherapy2
Poster Presentation Time:
6Month24Monday10:00-17:00

Study 506 (PROVE Study) – A Retrospective Phase IV Study on the Use of Perampanel in Real-World Clinical Care of Patients with Epilepsy: Adolescent Subgroup (Aged 12 to <18 Years)

Poster # p331
Poster Exhibition: Pharmacotherapy2
Poster Presentation Time:
6Month24Monday10:00-17:00

Efficacy and Safety of Perampanel as Adjunctive Therapy in Chinese Patients with Epilepsy Having Partial-Onset Seizures or Primary Generalized Tonic-Clonic Seizures: A Post Hoc Analysis of a Phase III, Double-Blind Study and an Open-Label Extension Study

Poster # p410
Poster Exhibition: Pediatric Epilepsy 2 Poster Presentation Time:
6Month24Monday10:00-17:00

Perampanel as Adjunctive Therapy in Younger Children (Aged 4 to <7 Years)
Safety and Efficacy in Patients with Partial-Onset Seizures (POS) or Primary Generalized Tonic-Clonic Seizures (PGTCS) in Older Children (Aged 7 to <12 Years): Final Results of the Core Study 311

Poster # p413
Poster Exhibition: Pediatric Epilepsy 2 Poster Presentation Time:
6Month24Monday10:00-17:00

Study 506 (PROVE Study) – A Retrospective Phase IV Study on the Use of Perampanel in Real-World Clinical Care of Patients with Epilepsy: Pediatric Subgroup (Under 12 Years of Age)

Poster # p424
Poster Exhibition: Pediatric Epilepsy 2 Poster Presentation Time:
6Month24Monday10:00-17:00

Impact of Perampanel Adjunctive Therapy on the Clinical Global Impression (CGI) Scale in Pediatric Patients (Aged 4 to <12 Years) with Partial-Onset Seizures (POS) or Primary Generalized Tonic-Clonic Seizures (PGTCS) in Study 311

Poster # p425
Poster Exhibition: Pediatric Epilepsy 2 Poster Presentation Time:
6Month24Monday10:00-17:00

Safety and Efficacy of Perampanel as Adjunctive Therapy in Japanese Pediatric Patients (Aged 4 to <12 Years) with Partial-Onset Seizures (POS) with or without Secondary Generalized Seizures (SGS): Final Results of the Core Study 311

Poster # p315
Poster Exhibition: Pharmacotherapy3
Poster Presentation Time:
6Month25Tuesday10:00-17:00

Efficacy and Safety of Perampanel Monotherapy in Patients with Previously Untreated Partial-Onset Seizures (POS): Preliminary Analysis of Study 342 (FREEDOM)

Poster # p520
Poster Exhibition: Pharmacotherapy3
Poster Presentation Time:
6Month25Tuesday10:00-17:00

Efficacy and Safety of Perampanel as Adjunctive Therapy in Indian Patients with Partial-Onset Seizures (POS) or Primary Generalized Tonic-Clonic Seizures (PGTCS): A Post Hoc Analysis of Phase II/III, Double-Blind Studies and an Open-Label Extension Study