Press Releases

Eisai To Present FYCOMPA® Seizure FREEDOM Data In New Onset Patients And Pediatric Data At The 33rd International Epilepsy Congress

-Results from the FREEDOM study, evaluating seizure freedom rates of FYCOMPA in new onset patients, including analyses at the 4 mg/day dose

-Two oral presentations featuring updated FYCOMPA pediatric data

Jun 13, 2019

WOODCLIFF LAKE, N.J., June 13, 2019 /PRNewswire/ -- Eisai Inc. today announced that it will present new data for FYCOMPA® (perampanel) CIII, including FREEDOM study results and the final results of one of the pediatric studies that supported the FDA approval for partial-onset seizures in patients as young as 4 years, at the upcoming 33rd International Epilepsy Congress (IEC) taking place on June 22-26, in Bangkok, Thailand. More than 45 poster presentations including data with perampanel will be featured at the meeting by both Eisai and independent investigators.

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FYCOMPA presentations will include:

  • Results from analyses of the 4 mg subset in the FREEDOM study, an open-label Phase III study in Japan and South Korea, evaluating the seizure freedom rates of FYCOMPA in newly diagnosed patients with partial-onset seizures (POS)
  • Latest results from Study 311, a study that supported the FDA approval of FYCOMPA in pediatric patients four years and older for the treatment of POS with or without secondarily generalized seizures
  • Safety and efficacy data from Study 506 (PROVE) in patients with epilepsy treated during routine clinical care

"We're excited to share the latest results of the 4 mg subset from the FREEDOM trial, a study that looks at seizure freedom rates in new onset POS patients treated with FYCOMPA," said Ivan Cheung, Chairman and CEO, Eisai Inc. "Meetings like IEC provide an important platform for us to continue towards our ultimate goal of achieving seizure freedom in patients suffering from partial-onset seizures."

The following details studies that will be presented by Eisai at this year's meeting:

Abstract Title and Authors

Presentation Scheduling Details

Epilepsy Data

Safety and efficacy of adjunctive perampanel in paediatric patients (aged 4 to ˂12 Years) with partial-onset seizures (POS) or primary generalised tonic-clonic seizures (PGTCS): final results from the 311 Core Study

 

Robert Flamini, Andras Fogarasi, Mathieu Milh, Steven Phillips, Shinsaku Yoshitomi, Leock Y Ngo, Anna Patten, Takao Takase, Antonio Laurenza

 

Platform Presentation

 

Time: Monday, June 24

3:30 p.m.-4:30 p.m. /15:30-16:30

(Time slot: 3:45-4:00/15:45-16:00)

 

Location: Centara Grand & Bangkok Convention Centre at CentralWorld

 

Safety and efficacy of adjunctive perampanel in younger (aged 4 to <7 years) and older (7 to <12 years) paediatric patients with partial-onset seizures (POS) or primary generalised tonic-clonic seizures (PGTCS): final results from the 311 core study

 

Andras Fogarasi, Robert Flamini, Mathieu Milh, Steven Phillips, Shinsaku Yoshitomi, Anna Patten, Takao Takase, Leock Y Ngo

Poster presentation number: p410

 

Poster Session: Paediatric Epileptology 2

 

Time: Monday, June 24

1:30 p.m.-3:00 p.m. /13:30-15:00

 

Location: Centara Grand & Bangkok Convention Centre at CentralWorld

 

Exhibition Hall on Level 22

Long-term rufinamide efficacy and association with phenotype and genotype in children with intractable epilepsy: a retrospective single center study (Rufinamide)

 

X Bozarth

Poster presentation number: p126

 

Poster Session: Paediatric Epileptology 1

 

Time: Sunday, June 23rd

1:30 p.m.-3:00 p.m./13:30-15:00

 

Location: Centara Grand & Bangkok Convention Centre at CentralWorld

 

Exhibition Hall on Level 22

Effect of concomitant enzyme-inducing anti-seizure drugs (EIASDs) on the safety and efficacy of adjunctive perampanel in patients aged 4 to ˂12 years with partial-onset seizures (POS): final results from the 311 Core Study

 

Mathieu Milh, Robert Flamini, Andras Fogarasi, Steven Phillips, Shinsaku Yoshitomi, Anna Patten, Takao Takase, Leock Y. Ngo

Platform Presentation

 

Time: Monday, June 24

3:30 p.m.-4:30 p.m. /15:30-16:30

(Time slot: 4:00-4:15/16:00-16:15)

 

Location: Centara Grand & Bangkok Convention Centre at CentralWorld

Adjunctive perampanel in paediatric patients with epilepsy: population pharmacokinetic (PK) and exposure-response analyses

 

Oneeb Majid, Larisa Reyderman, Jim Ferry, Ziad Hussein

Poster presentation number: p215

 

Poster Session: Paediatric Epileptology 1

 

Time: Sunday, June 23

1:30 p.m.-3:00 p.m./ 13:30-15:00

 

Location: Centara Grand & Bangkok Convention Centre at CentralWorld

 

Exhibition Hall on Level 22

Perampanel in real-world clinical care of patients with epilepsy: retrospective Phase IV study 506 (PROVE Study)

 

Robert T Wechsler, James Wheless, Marcelo Lancman, Sami Aboumatar, Anna Patten, Betsy Williams, Manoj Malhotra

Poster presentation number: p328

 

Poster Session: Drug Therapy 2

 

Time: Monday, June 24

1:30 p.m.-3:00 p.m./13:30-15:00  

 

Location: Centara Grand & Bangkok Convention Centre at CentralWorld

 

Exhibition Hall on Level 22

Study 506 (PROVE Study) –a retrospective, Phase IV study of perampanel in real-world clinical care of patients with epilepsy: adolescent subgroup (aged 12 to <18 Years)

 

Eric Segal, James Wheless, Katherine Moretz, Patricia Penovich, Anna Patten, Betsy Williams, Manoj Malhotra

Poster presentation number: p329

 

Poster Session: Drug Therapy 2

 

Time: Monday, June 24

1:30 p.m.-3:00 p.m. /13:30-15:00

 

Location: Centara Grand & Bangkok Convention Centre at CentralWorld

 

Exhibition Hall on Level 22

Study 506 (PROVE Study)–a retrospective, Phase IV study of perampanel in real-world clinical care of patients with epilepsy: pediatric subgroup (aged <12 Years)

 

Katherine Moretz, James Wheless, Eric Segal, Marcelo Lancman, Anna Patten, Betsy Williams, Manoj Malhotra

Poster presentation number: p413

 

Poster Session: Paediatric Epileptology 2

 

Time: Monday, June 24

1:30 p.m.-3:00 p.m. /13:30-15:00  

 

Location: Centara Grand & Bangkok Convention Centre at CentralWorld

 

Exhibition Hall on Level 22

Safety and efficacy of adjunctive perampanel in Japanese paediatric patients (aged 4 to < 12 years) with partial-onset seizures (POS) with or without secondarily generalised seizures (SGS): final results from the 311 Core Study

 

Shinsaku Yoshitomi, Toshihide Watanabe, Ryutaro Kira, Kaeko Ishiba, Anna Patten, Takao Takase, Leock Y Ngo

Poster presentation number: p425

 

Poster Session: Paediatric Epileptology 2

 

Time: Monday, June 24

1:30 p.m.-3:00 p.m. /13:30-15:00

 

Location: Centara Grand & Bangkok Convention Centre at CentralWorld

 

Exhibition Hall on Level 22

Effect of adjunctive perampanel on Clinical Global Impression (CGI) in paediatric patients (aged 4 to ˂12 years) with partial-onset seizures (POS) or primary generalised tonic-clonic seizures (PGTCS) in Study 311

 

Andras Fogarasi, Steven Phillips, Robert Flamini, Mathieu Milh,  Shinsaku Yoshitomi, Anna Patten, Takao Takase, Leock Y Ngo

Poster presentation number: p424

 

Poster Session: Paediatric Epileptology 2

 

Time: Monday, June 24

1:30 p.m.-3:00 p.m. /13:30-15:00

 

Location: Centara Grand & Bangkok Convention Centre at CentralWorld

 

Exhibition Hall on Level 22

Efficacy and safety of perampanel monotherapy in previously untreated patients with partial-onset seizures (POS): primary analysis of Study 342 (FREEDOM study)

 

Takamichi Yamamoto, Ji-Hyun Kim, Sung-Chul Lim, Hirotomo Ninomiya, Yuichi Kubota, Risa Matsunaga, Hiroyuki Higashiyama

Poster presentation number: p315

 

Poster Session: Drug Therapy 1

 

Time: Tuesday, June 25

1:30 p.m.- 3:00 p.m. /13:30-15:00

 

Location: Centara Grand & Bangkok Convention Centre at CentralWorld

 

Exhibition Hall on Level 22

Efficacy and safety of adjunctive perampanel in Chinese patients with partial-onset seizures or primary generalised tonic-clonic seizures: post hoc analysis of Phase III double-blind and open-label extension studies

 

Liao Weiping, Zhou Dong, Hong Zhen, Anna Patten, Amitabh Dash, Manoj Malhotra

Poster presentation number: p331

 

Poster Session: Drug Therapy 2

 

Time: Monday, June 24

1:30 p.m.-3:00 p.m. /13:30-15:00

 

Location: Centara Grand & Bangkok Convention Centre at CentralWorld

 

Exhibition Hall on Level 22

Efficacy and safety of adjunctive perampanel in Indian patients with partial-onset seizures (POS) or primary generalised tonic-clonic seizures (PGTCS): post hoc analysis of Phase II and III double-blind and open-label extension (OLEx) studies

 

Man Mohan Mehndiratta, Manoj Gulhane, Shaik A Jabeen, Anna Patten, Amitabh Dash, Manoj Malhotra

Poster presentation number: p520

 

Poster Session: Drug Therapy 3

 

Time: Tuesday, June 25

1:30 p.m.-3:00 p.m. /13:30-15:00  

 

Location: Centara Grand & Bangkok Convention Centre at CentralWorld

 

Exhibition Hall on Level 22

Perampanel does not worsen myoclonic and absence seizures

 

Christian Brandt, Robert T Wechsler, Terence J O'Brien, Anna Patten, Betsy Williams, Manoj Malhotra, Leock Y Ngo, Bernhard J Steinhoff

Poster presentation number: p317

 

Poster Session: Drug Therapy 2

 

Time: Monday, June 24

1:30 p.m.-3:00 p.m. /13:30-15:00

 

Location: Centara Grand & Bangkok Convention Centre at CentralWorld

 

Exhibition Hall on Level 22

First-line perampanel added to monotherapy in patients with partial-onset seizures, with or without secondary generalised seizures (Study 412)

 

Dong-Wook Kim, Jee-Hyun Kim, Sang-Gun Lee, Dae-Won Seo, Sung-Ho Park, Myoung-Gyu Kim, Seung-Bong Hong, Kyung Huh, Sang-Ahm Lee

Poster presentation number: p125

 

Poster Session: Drug Therapy 1

 

Time: Sunday, June 23

1:30 p.m.-3:00 p.m./13:30 – 15:00

 

Location: Centara Grand & Bangkok Convention Centre at CentralWorld


Exhibition Hall on Level 22

Portions of this release discuss investigational uses for FYCOMPA. It is not intended to convey conclusions about efficacy or safety. There is no guarantee that any investigational uses will successfully complete clinical development or gain FDA approval.

INDICATION FOR FYCOMPA
FYCOMPA® (perampanel) is indicated in patients with epilepsy aged 4 years and older for partial-onset seizures (POS) with or without secondarily generalized seizures and adjunctive therapy for patients aged 12 years and older for primary generalized tonic-clonic (PGTC) seizures.

IMPORTANT SAFETY INFORMATION FOR FYCOMPA


WARNING: SERIOUS PSYCHIATRIC AND BEHAVIORAL REACTIONS

- Serious or life-threatening psychiatric and behavioral adverse reactions including aggression, hostility, irritability, anger, and homicidal ideation and threats have been reported in patients taking FYCOMPA
- These reactions occurred in patients with and without prior psychiatric history, prior aggressive behavior, or concomitant use of medications associated with hostility and aggression
- Advise patients and caregivers to contact a healthcare provider immediately if any of these reactions or changes in mood, behavior, or personality that are not typical for the patient are observed while taking FYCOMPA or after discontinuing FYCOMPA
- Closely monitor patients particularly during the titration period and at higher doses
- FYCOMPA should be reduced if these symptoms occur and should be discontinued immediately if symptoms are severe or are worsening
 

SERIOUS PSYCHIATRIC AND BEHAVIORAL REACTIONS
In the partial-onset seizures clinical trials, hostility- and aggression-related adverse reactions occurred in 12% and 20% of patients randomized to receive FYCOMPA at doses of 8 mg and 12 mg per day, respectively, compared to 6% of patients in the placebo group. These effects were dose-related and generally appeared within the first 6 weeks of treatment, although new events continued to be observed through more than 37 weeks. These effects in FYCOMPA-treated patients led to dose reduction, interruption, and discontinuation more frequently than placebo-treated patients. Homicidal ideation and/or threat have also been reported postmarketing in patients treated with FYCOMPA. The combination of alcohol and FYCOMPA significantly worsened mood and increased anger. Patients taking FYCOMPA should avoid the use of alcohol. Patients, their caregivers, and families should be informed that FYCOMPA may increase the risk of psychiatric events. Patients should be monitored during treatment and for at least one month after the last dose of FYCOMPA, and especially when taking higher doses and during the initial few weeks of drug therapy (titration period) or at other times of dose increases. Similar serious psychiatric and behavioral events were observed in the primary generalized tonic-clonic (PGTC) seizure clinical trial.

SUICIDAL BEHAVIOR AND IDEATION
Antiepileptic drugs (AEDs), including FYCOMPA, increase the risk of suicidal thoughts or behavior in patients. Anyone considering prescribing FYCOMPA or any other AED must balance the risk of suicidal thoughts or behavior with the risk of untreated illness. Epilepsy and many other illnesses for which AEDs are prescribed are themselves associated with morbidity and mortality and an increased risk of suicidal thoughts and behavior. Patients, their caregivers, and families should be informed of the risk and advised to monitor and immediately report the emergence or worsening of depression, suicidal thoughts or behavior, thoughts about self-harm and/or any unusual changes in mood or behavior. Should suicidal thoughts and behavior emerge during treatment, consider whether the emergence of these symptoms in any given patient may be related to the illness being treated.

DIZZINESS AND GAIT DISTURBANCE
FYCOMPA caused dose-related increases in events related to dizziness and disturbance in gait or coordination. Dizziness and vertigo were reported in 35% and 47% of patients in the partial-onset seizure trials randomized to receive FYCOMPA at doses of 8 mg and 12 mg per day, respectively, compared to 10% of placebo-treated patients. Gait disturbance related events were reported in 12% and 16% of patients in the partial-onset seizure clinical trials randomized to receive FYCOMPA at doses of 8 mg and 12 mg per day, respectively, compared to 2% of placebo-treated patients. These adverse reactions occurred mostly during the titration phase. These adverse reactions were also observed in the PGTC seizure clinical trial.

SOMNOLENCE AND FATIGUE
FYCOMPA caused dose-dependent increases in somnolence and fatigue-related events. Somnolence was reported in 16% and 18% of patients in the partial-onset seizure trials randomized to receive FYCOMPA at doses of 8 mg and 12 mg per day, respectively, compared to 7% of placebo-treated patients. Fatigue-related events were reported in 12% and 15% of patients in the partial-onset seizure trials randomized to receive FYCOMPA at doses of 8 mg and 12 mg per day, respectively, compared to 5% of placebo-treated patients. These adverse reactions occurred mostly during the titration phase. These adverse reactions were also observed in the PGTC seizure clinical trial. Patients should be advised against engaging in hazardous activities requiring mental alertness, such as operating motor vehicles or dangerous machinery, until the effect of FYCOMPA is known. Patients should be carefully observed for signs of central nervous system (CNS) depression when FYCOMPA is used with other drugs with sedative properties because of potential additive effects.

FALLS
Falls were reported in 5% and 10% of patients in the partial-onset seizure clinical trials randomized to receive FYCOMPA at doses of 8 mg and 12 mg per day, respectively, compared to 3% of placebo-treated patients.

DRUG REACTION WITH EOSINOPHILIA AND SYSTEMIC SYMPTOMS (DRESS)
DRESS, also known as multiorgan hypersensitivity, has been reported in patients taking AEDs, including FYCOMPA. DRESS may be fatal or life-threatening. DRESS typically, although not exclusively, presents with fever, rash, lymphadenopathy, and/or facial swelling, in association with other organ system involvement. If signs or symptoms are present, immediately evaluate the patient and discontinue FYCOMPA if an alternative etiology for signs or symptoms cannot be established.

WITHDRAWAL OF AEDs
A gradual withdrawal is generally recommended with AEDs to minimize the potential of increased seizure frequency, but if withdrawal is a response to adverse events, prompt withdrawal can be considered.

MOST COMMON ADVERSE REACTIONS
The most common adverse reactions in patients aged 12 years and older receiving FYCOMPA (≥5% and ≥1% higher than placebo) include dizziness, somnolence, fatigue, irritability, falls, nausea, weight gain, vertigo, ataxia, headache, vomiting, contusion, abdominal pain, and anxiety. Adverse reactions in patients aged 4 to <12 years were generally similar to patients aged 12 years and older.

DRUG INTERACTIONS
FYCOMPA may decrease the efficacy of contraceptives containing levonorgestrel. Plasma levels of perampanel were decreased when administered with known moderate and strong CYP3A4 inducers, including, carbamazepine, phenytoin, or oxcarbazepine. Multiple dosing of FYCOMPA 12 mg per day enhanced the effects of alcohol on vigilance and alertness, and increased levels of anger, confusion, and depression. These effects may also be seen when FYCOMPA is used in combination with other CNS depressants.

PREGNANCY AND LACTATION
Physicians are advised to recommend that pregnant patients taking FYCOMPA enroll in the North American Antiepileptic Drug (NAAED) Pregnancy Registry. Caution should be exercised when FYCOMPA is administered to pregnant or nursing women as there are no adequate data on the developmental risk associated with use in pregnant women, and no data on the presence of perampanel in human milk, the effects on the breastfed child, or the effects of the drug on milk production.

HEPATIC AND RENAL IMPAIRMENT
Use in patients with severe hepatic or severe renal impairment is not recommended. Dosage adjustments are recommended in patients with mild or moderate hepatic impairment. Use with caution in patients with moderate renal impairment.

DRUG ABUSE AND DEPENDENCE
FYCOMPA is a Schedule III controlled substance and has the potential to be abused and lead to drug dependence and withdrawal symptoms including anxiety, nervousness, irritability, fatigue, asthenia, mood swings, and insomnia.

Please see full Prescribing Information, including Boxed WARNING.  

About FYCOMPA 
FYCOMPA is a prescription medicine used in people with epilepsy aged 4 and older alone or with other medicines to treat partial-onset seizures with or without secondarily generalized seizures, and with other medicines to treat primary generalized tonic-clonic seizures for people with epilepsy aged 12 and older.

FYCOMPA, a unique oral medication, is a selective, non-competitive AMPA (alpha-amino-3-hydroxy-5- methyl-4-isoxazolepropionic acid) receptor antagonist. The precise mechanism by which FYCOMPA exerts its antiepileptic effects in humans is unknown. In a pharmacokinetic study, it has been demonstrated that because of its long half-life, a missed dose of FYCOMPA does not significantly impact plasma levels.

FYCOMPA is supplied as 2 mg, 4 mg, 6 mg, 8 mg, 10 mg and 12 mg film-coated tablets, and as a 0.5 mg/mL oral suspension formulation. FYCOMPA has been designated by the U.S. Drug Enforcement Administration as a federally-controlled substance (CIII).

About Epilepsy
Epilepsy is a medical condition that produces seizures affecting a variety of mental and physical functions. Epilepsy is one of the most common neurological disorders, which affects about 3.4 million people in the United States, including 470,000 children. Children with uncontrolled seizures are at greater risk for sudden unexpected death in epilepsy (SUDEP), which is relatively uncommon in childhood, but the risk increases if epilepsy persists into adulthood.

Partial-onset seizures are the most common type of seizure seen in people with epilepsy, accounting for 60 percent of all seizures. Convulsive seizures account for up to 25 percent of all epilepsy, with primary generalized tonic-clonic seizures being one of the most common and severe forms of seizures.

Missed medication doses are the number one cause of breakthrough seizures, which can cause significant injury to patients. People who experience breakthrough seizures have an increased risk of fractures or head injuries, emergency room (ER) visits, and hospitalization, as well as an associated increase in healthcare costs. 

About Eisai 
Eisai is a leading global research and development-based pharmaceutical company headquartered in Japan, with approximately 10,000 employees worldwide. We define our corporate mission as "giving first thought to patients and their families and to increasing the benefits health care provides," which we call our human health care (hhc) philosophy. We strive to realize our hhc philosophy by delivering innovative products in therapeutic areas with high unmet medical needs, including Oncology and Neurology. In the spirit of hhc, we take that commitment even further by applying our scientific expertise, clinical capabilities and patient insights to discover and develop innovative solutions that help address society's toughest unmet needs, including neglected tropical diseases and the Sustainable Development Goals.

For more information about Eisai, please visit www.eisai.com (for global), us.eisai.com (for U.S.) or www.eisai.co.uk (for U.K.), and connect with us on Twitter (U.S. and global) and LinkedIn (for U.S.).

Contact:

Media Inquiries
James Merse
Eisai Inc.
201-746-2088
media@eisai.com

SOURCE Eisai Inc.