Eisai to Present New Perampanel Data at the 73rd American Epilepsy Society Annual Meeting

TOKYO, Dec. 3, 2019 /PRNewswire/ -- Eisai Co., Ltd. (Headquarters: Tokyo; CEO: Haruo Naito; hereinafter referred to as "Eisai") recently announced that the latest data on its anti-epileptic drug (AED) perampanel (Chinese name: Wei Ke Tai) will be presented at the 73rd Annual Meeting of the American Epilepsy Society (AES 2019), held in Baltimore, Maryland, USA, from December 6 to 10, 2019.

Eisai will present 38 poster presentations at AES 2019, including results from the Phase III clinical trial (FREEDOM/Study 342) evaluating the efficacy and safety of perampanel monotherapy in treatment-naïve patients aged 12 to 74 years with partial-onset seizures, as well as findings from Study 506, a retrospective Phase IV study on the use of perampanel in real-world clinical care of patients with epilepsy. Including investigator-initiated studies, more than 40 scientific poster presentations on perampanel will be showcased at AES 2019.

Perampanel is a first-line antiepileptic drug (AED) and a first-in-class oral, once-daily antiepileptic tablet developed by Eisai’s Tsukuba Research Laboratories. The oral suspension formulation of this drug has been approved for marketing 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. Perampanel is currently 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. Furthermore, in the United States, the drug has been approved for both 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 and is committed to promoting perampanel worldwide. The company’s mission is to help more patients suffering from epilepsy achieve freedom from seizures. Eisai strives to meet the diverse needs of patients with epilepsy and their families, thereby enhancing their well-being.

Key Poster Presentations on Perampanel:

Abstract Number

Paper Date and Time

Abstract Title

Study 342 (FREEDOM Study)

Abstract No.: #2.215
Sunday, December 8
Poster Presentation: 10:00-16:00
Poster Discussion: 12:00-14:00

Perampanel Monotherapy for Patients with Newly Diagnosed or Currently Untreated Recurrent Partial-Onset Epilepsy
Efficacy and Safety: Final Analysis of Core Data from Study 342 (FREETION) at 4 mg/day and 8 mg/day

Abstract No.: #3.318
Monday, December 9
Poster Presentations: 8:00–14:00
Poster Discussion: 12:00-14:00

Perampanel Monotherapy in Patients with Newly Diagnosed or Currently Untreated Recurrent Partial-Onset Seizures:
Efficacy and Safety in the Open-Label Extension Phase of Study 342

Study 506 (PROVE Study)

Abstract No.: #1.304
Saturday, December 7
Poster Presentations: 12:00-18:00
Poster Discussion: 12:00-14:00

PROVE Study 506: Perampanel as Adjunctive or Monotherapy in Real-World Clinical Care of Patients with Epilepsy
Lenvatinib

Abstract No.: #1.306
Saturday, December 7
Poster Presentations: 12:00-18:00
Poster Discussion: 12:00-14:00

Perampanel in the Actual Clinical Care of Epilepsy Patients at Duke University Medical Center in Durham, North Carolina:
Regional Comparison of PROVE Study 506 Results

Abstract No.: #1.311
Saturday, December 7
Poster Presentations: 12:00–18:00
Poster Discussion: 12:00-14:00

PROVE Study 506: A Phase IV Retrospective Study of Real-World Clinical Care in Epilepsy Patients Aged 18 Years and Older

Abstract No.: #1.312
Sunday, December 7
Poster Presentations: 12:00-18:00
Poster Discussion: 12:00–14:00

Perampanel in the Real-World Clinical Care of Patients with Epilepsy: Results from the Phase IV Retrospective PROVE Study 506

Abstract No.: #1.313
Sunday, December 7
Poster Presentations: 12:00–18:00
Poster Discussion: 12:00-14:00

PROVE Study 506: A Phase IV Retrospective Study of Real-World Clinical Care in Patients with Epilepsy Aged 4 Years and Older

Abstract Number: #2.209
Sunday, December 8
Poster Presentations: 10:00-16:00
Poster Discussion: 12:00-14:00

PROVE Study 506: A Phase IV Retrospective Study of Real-World Clinical Care in Epilepsy Patients Aged 18 Years and Older

Abstract Number: #3.301
Monday, December 9
Poster Presentations: 8:00–14:00
Poster Discussion: 12:00–14:00

Perampanel in Real-World Clinical Care of Patients with Epilepsy: Enzyme Induction in the Phase IV Retrospective PROVE Study 506
Impact of Antiepileptic Drugs on Drug Retention Rate

Abstract No.: #3.303
Monday, December 9
Poster Presentations: 8:00-14:00
Poster Discussion: 12:00–14:00

PROVE Study 506: A Phase IV Retrospective Study of Real-World Clinical Care in Epilepsy Patients Aged 12 Years and Older

Abstract No.: #3.316
Monday, December 9
Poster Presentations: 8:00–14:00
Poster Discussion: 12:00-14:00

Perampanel in the Real-World Clinical Care of Patients with Epilepsy in the Northeast Epilepsy Consortium of Hackensack, New Jersey: PROVE
Regional Comparison of Study 506 Results

Other Major Papers

Abstract No.: #1.303
Saturday, December 7
Poster Presentations: 12:00-18:00
Poster Discussion: 12:00-14:00

ELEVATE Study 410 Registration Update: In Focal Seizures or Primary Generalized Tonic-Clonic Seizures of Epilepsy
Phase IV Study of Perampanel as Monotherapy or First Add-On Therapy in Patients Aged 12 Years or Older

Abstract Number: #1.305
Saturday, December 7
Poster Presentations: 12:00–18:00
Poster Discussion: 12:00-14:00

Efficacy and Safety of Perampanel as the First Add-On Therapy for Patients with Partial-Onset Seizures, Important
Post-hoc Analysis of the FAME Study on the Use of Antiepileptic Drugs (Study 412)

Abstract No.: #2.207
Sunday, December 8
Poster Presentations: 10:00-16:00
Poster Discussion: 12:00-14:00

Disclosure of Perampanel -- Response Relationship of Cognition and Safety in Pediatric Epilepsy Patients (4-12 Years Old) (Study
311，232)

Abstract Number: #2.216
Sunday, December 8
Poster Presentations: 10:00-16:00
Poster Discussion: 12:00–14:00

Adverse Event Profile of Perampanel as First Add-On Therapy in Patients with Focal Onset Seizures: FAME
Research Analysis (Study 412)

<Editor's Note>

1. About Perampanel (generic name; brand name: Fycompa®)

Perampanel is a first-in-class antiepileptic drug exclusively developed by Eisai. One of the mechanisms underlying epileptic seizures is mediated by the neurotransmitter glutamate. Perampanel acts as a highly selective, non-competitive antagonist of AMPA-type receptors, reducing neuronal hyperexcitability by targeting glutamate activity at AMPA receptors on the postsynaptic cell membrane. Perampanel tablets are commercially available for once-daily oral administration at bedtime. Additionally, the oral suspension formulation of this drug has been approved for marketing in the United States and Europe.

Currently, perampanel has been approved in more than 55 countries and regions, including the United States, Japan, Europe, and Asia, for adjunctive therapy of partial-onset seizures (with or without secondary generalization) in patients with epilepsy aged 12 years and older. Eisai has also submitted an application in China for the use of perampanel as adjunctive therapy for partial-onset seizures in epilepsy, which has been designated for priority review. Furthermore, perampanel has been approved in more than 50 countries across Europe and Asia, including the United States and Japan, for adjunctive therapy of primary generalized tonic-clonic seizures in patients with epilepsy aged 12 years and older. In the United States, perampanel has been approved for both monotherapy and adjunctive therapy of partial-onset seizures (with or without secondary generalization) in patients with epilepsy aged 4 years and older.

Eisai has submitted a supplemental New Drug Application in Japan, seeking approval for the use of perampanel as monotherapy for partial-onset seizures in pediatric patients aged 4 years and older, along with an application to launch a fine-granule formulation. In Europe, Eisai has also submitted an application seeking additional approval for the use of perampanel as adjunctive therapy for partial-onset seizures (with or without secondary generalization) or primary generalized tonic-clonic seizures in pediatric patients with epilepsy.

In addition, Eisai is conducting a global Phase III clinical study (Study 338) aimed at using the drug to treat seizures associated with Lennox-Gastaut syndrome.