Eisai to Present Convulsive Seizure Freedom Data Evaluating FYCOMPA® in Newly Diagnosed Partial Onset Patients at Upcoming American Epilepsy Society Annual Meeting
WOODCLIFF LAKE, N.J., Nov. 25, 2019 /PRNewswire/ -- Eisai Inc. today will present FYCOMPA(®) (perampanel) CIII data on convulsive seizure freedom and additional analyses of FYCOMPA at the upcoming American Epilepsy Society Annual Meeting taking place from December 6 to December 10 in Baltimore, Maryland. Of Eisai's 38 scientific posters on FYCOMPA, 23 include convulsive seizure freedom data, underscoring Eisai's commitment to helping as many patients as possible achieve the ultimate goal of seizure freedom. Scientific posters will be presented by both Eisai and independent investigators, further reinforcing a collective commitment to advancing research on FYCOMPA.
Key data to be presented include:
-- 26-week results from the FREEDOM study, an open-label Phase III study in
Japan and South Korea, evaluating convulsive seizure freedom rates of
FYCOMPA at 4 and 8 mg/day in newly diagnosed patients with partial-onset
seizures (POS)
-- Real-world data that evaluated and compared healthcare resource
utilization (HRU) (i.e., all-cause and epilepsy-related
hospitalizations) among patients treated with select AED combinations
with and without FYCOMPA
-- Retention rates of FYCOMPA from the PROVE Study, a retrospective,
multicenter, non-interventional Phase IV study
-- Adverse event profile of FYCOMPA as first adjunctive therapy during the
FAME trial, an open-label, single-arm, Phase IV study
"We look forward to sharing the latest results of the FREEDOM Study, which evaluated convulsive seizure freedom rates of FYCOMPA 4 and 8 mg/day in newly diagnosed patients with partial-onset seizures," said Lynn Kramer, M.D., Chief Clinical Officer and Chief Medical Officer, Neurology Business Group, Eisai. "At Eisai, we strive to bring the potential of seizure freedom to as many patients as possible and are particularly excited about sharing seizure freedom rates."
Additionally, Eisai will host its annual "Research Updates from Eisai" on December 8 from 8:00 a.m.-11:00 a.m. in Room 324-326, at the Baltimore Convention Center. This event will feature 30 of Eisai's posters as well as select posters from Investigator-Initiated Studies (IIS). Further, Eisai's Innovation Pavilion, titled "Exploring Data--An Immersive Experience" will host an interactive experience into our epilepsy research and latest scientific information on FYCOMPA.
"The breadth of FYCOMPA data we are presenting at AES demonstrates our commitment to the epilepsy community and real-world outcomes for our patients," said Ivan Cheung, Chairman and CEO, Eisai Inc. "These data encourage us to continue to develop and explore innovative therapies in our relentless pursuit of helping patients achieve the goal of seizure freedom."
In September 2018, FYCOMPA was approved for monotherapy and adjunctive use in pediatric patients four years and older for the treatment of POS with or without secondarily generalized seizures. The approval includes both the FYCOMPA tablet and oral suspension formulations. To date, FYCOMPA is approved in 55 countries and has been used to treat more than 200,000 patients worldwide across all indications.
The following are some of the studies that will be presented by Eisai at this year's AES Annual Meeting:
Abstract Name
Session (All Times Eastern)
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Convulsive Seizure Freedom
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Efficacy and Safety of
Perampanel Monotherapy
in Patients with Newly
Diagnosed or Currently
Untreated Recurrent
Partial-Onset
Seizures: Final
Analysis of Study 342
(FREEDOM) 4 and 8 mg/
day Core Data
Poster presentation number: 2.215
Takamichi Yamamoto, Ji-
Hyun Kim, Sung Chul
Lim, Hirotomo Ninomiya,
Yuichi Kubota, Risa
Matsunaga, Hidetaka
Hiramatsu, Hiroyuki
Higashiyama
Poster Session: 2
Time: Sunday, December 8
12:00 p.m. to 2:00 p.m.
Location: Baltimore, MD
Baltimore Convention Center
Level 100, Hall E/F
--- ---
Real-world Use
---
PROVE Study 506:
Retrospective, Phase IV
Study of Perampanel in
Real-World Clinical
Care of Patients Aged
12 to <18 Years with
Epilepsy
Poster presentation number: 2.209
Patricia Penovich, Eric
Segal, Anna Patten,
Manoj Malhotra
Poster Session: 2
Time: Sunday, December 8
12:00 p.m. to 2:00 p.m.
Location: Baltimore, MD
Baltimore Convention Center
Level 100, Hall E/F
--- ---
PROVE Study 506:
Perampanel as
Adjunctive Therapy or
Monotherapy in Real-
World Clinical Care of
Patients with Epilepsy
Poster presentation number: 1.304
Ruben Kuzniecky, Robert
T Wechsler, Anna
Patten, Manoj Malhotra
Poster Session: 1
Time: Saturday, December 7
12:00 p.m. to 2:00 p.m.
Location: Baltimore, MD
Baltimore Convention Center
Level 100, Hall E/F
---
Perampanel in Real-
World Clinical Care of
Patients with Epilepsy
at Duke University
Medical Center, Durham,
North Carolina: A
Regional Comparison of
Results from PROVE
Study 506
Poster presentation number: 1.306
Saurabh R Sinha, Selim
Benbadis, Muhammad
Zafar, Anna Patten,
Manoj Malhotra
Poster Session: 1
Time: Saturday, December 7
12:00 p.m. to 2:00 p.m.
Location: Baltimore, MD
Baltimore Convention Center
Level 100, Hall E/F
--- ---
PROVE Study 506:
Retrospective, Phase IV
Study of Perampanel in
Real-World Clinical
Care of Patients Aged
>=18 Years with
Epilepsy
Poster presentation number: 1.311
Alejandro Salah, Anna
Patten, Manoj Malhotra
Poster Session: 1
Time: Saturday, December 7
12:00 p.m. to 2:00 p.m.
Location: Baltimore, MD
Baltimore Convention Center
Level 100, Hall E/F
--- ---
Perampanel in Real-
World Clinical Care of
Patients with Epilepsy:
Results from the
Retrospective, Phase IV
PROVE Study 506
Poster presentation number: 1.312
James Wheless, Anna
Patten, Manoj Malhotra
Poster Session: 1
Time: Saturday, December 7
12:00 p.m. to 2:00 p.m.
Location: Baltimore, MD
Baltimore Convention Center
Level 100, Hall E/F
--- ---
PROVE Study 506:
Retrospective, Phase IV
Study of Perampanel in
Real-World Clinical
Care of Patients Aged
<4 Years with Epilepsy
Poster presentation number: 1.313
Muhammad Zafar, Anna
Patten, Manoj Malhotra
Poster Session: 1
Time: Saturday, December 7
12:00 p.m. to 2:00 p.m.
Location: Baltimore, MD
Baltimore Convention Center
Level 100, Hall E/F
--- ---
Perampanel in Real-
World Clinical Care of
Patients with Epilepsy:
Effect of Enzyme-
Inducing Anti-Seizure
Drugs on Retention Rate
in the Retrospective
Phase IV PROVE Study
506
Poster presentation number: 3.301
Sami Aboumatar, Anna
Patten, Manoj Malhotra
Poster Session: 3
Time: Monday, December 9
12:00 p.m. to 2:00 p.m.
Location: Baltimore, MD
Baltimore Convention Center
Level 100, Hall E/F
---
Perampanel in Real-
World Clinical Care of
Patients with Epilepsy
at Carle Foundation
Hospital, Urbana,
Illinois: A Regional
Comparison of Results
from PROVE Study 506
Poster presentation number: 3.307
Graham Huesmann, Anna
Patten, Manoj Malhotra
Poster Session: 3
Time: Monday, December 9
12:00 p.m. to 2:00 p.m.
Location: Baltimore, MD
Baltimore Convention Center
Level 100, Hall E/F
---
Perampanel in Real-
World Clinical Care of
Patients with Epilepsy
at Idaho Comprehensive
Epilepsy Center: A
Regional Comparison of
Results from PROVE
Study 506
Poster presentation number: 3.308
Robert T Wechsler, Anna
Patten, Manoj Malhotra
Poster Session: 3
Time: Monday, December 9
12:00 p.m. to 2:00 p.m.
Location: Baltimore, MD
Baltimore Convention Center
Level 100, Hall E/F
---
Perampanel in Real-World
Clinical Care of
Patients with Epilepsy
at Le Bonheur Children's
Hospital, Memphis,
Tennessee: A Regional
Comparison of Results
from PROVE Study 506
Poster presentation number: 3.315
Trevor Resnick, James
Wheless, Anna Patten,
Manoj Malhotra
Poster Session: 3
Time: Monday, December 9
12:00 p.m. to 2:00 p.m.
Location: Baltimore, MD
Baltimore Convention Center
Level 100, Hall E/F
---
Perampanel in Real-
World Clinical Care of
Patients with Epilepsy
at Northeast Regional
Epilepsy Group,
Hackensack, New Jersey:
A Regional Comparison
of Results from PROVE
Study 506
Poster presentation number: 3.316
Hyunmi Choi, Eric Segal,
Anna Patten, Manoj
Malhotra
Poster Session: 3
Time: Monday, December 9
12:00 p.m. to 2:00 p.m.
Location: Baltimore, MD
Baltimore Convention Center
Level 100, Hall E/F
---
Pediatric Data
---
Long-Term Safety and
Efficacy of Adjunctive
Perampanel in Pediatric
Patients (Aged 4 to <7
and 7 to <12 Years)
with Partial-Onset
Seizures or Primary
Generalized Tonic-
Clonic Seizures in
Study 311
Poster presentation number: 3.311
Steven Phillips, Anna
Patten, Leock Y Ngo
Poster Session: 3
Time: Monday, December 9
12:00 p.m. to 2:00 p.m.
Location: Baltimore, MD
Baltimore Convention Center
Level 100, Hall E/F
--- ---
Long-Term Cognitive
Effects of Adjunctive
Perampanel in Patients
(Aged 4 to <12 Years)
with Partial-Onset or
Primary Generalized
Tonic-Clonic Seizures:
Post Hoc Analysis by
Responder Status and
Dose
Poster presentation number: 1.315
Barry Gidal, Kimford J
Meador, Anna Patten,
Manoj Malhotra, Leock Y
Ngo
Poster Session: 1
Time: Saturday, December 7
12:00 p.m. to 2:00 p.m.
Location: Baltimore, MD
Baltimore Convention Center
Level 100, Hall E/F
--- ---
Perampanel
Exposure-Response
Relationships for
Cognition and Safety in
Pediatric Patients
(Aged 4 to <12 years)
with Epilepsy (study
311, 232)
Poster presentation number: 2.207
Oneeb Majid, Larisa
Reyderman, Jim Ferry,
Ziad Hussein
Poster Session: 2
Time: Sunday, December 8
12:00 p.m. to 2:00 p.m.
Location: Baltimore, MD
Baltimore Convention Center
Level 100, Hall E/F
--- ---
Effect of Concomitant
Anti-Seizure Drugs
During Adjunctive
Perampanel Treatment in
Pediatric Patients
(Aged 4 to <12 Years):
Post Hoc Analysis of
Study 311
Poster presentation number: 2.208
Andras Fogarasi, Anna
Patten, Leock Y Ngo
Poster Session: 2
Time: Sunday, December 8
12:00 p.m. to 2:00 p.m.
Location: Baltimore, MD
Baltimore Convention Center
Level 100, Hall E/F
--- ---
Efficacy and Safety of
Adjunctive Perampanel
for the Treatment of
Primary Generalized
Tonic-Clonic Seizures
(PGTCS): Analysis of
Adult, Adolescent, and
Pediatric Populations
(Studies 332, 311)
Poster presentation number: 2.210
Gregory L Krauss, Anna
Patten, Manoj Malhotra,
Leock Y Ngo
Poster Session: 2
Time: Sunday, December 8
12:00 p.m. to 2:00 p.m.
Location: Baltimore, MD
Baltimore Convention Center
Level 100, Hall E/F
--- ---
Long-Term Effects of
Adjunctive Perampanel
on Cognition and Growth
Development in Patients
(Aged 4 to <12 Years)
with Partial-Onset
Seizures and Primary
Generalized Tonic-
Clonic Seizures in
Study 311
Poster presentation number: 2.211
J Ben Renfroe, Anna
Patten, Manoj Malhotra,
Leock Y Ngo
Poster Session: 2
Time: Sunday, December 8
12:00 p.m. to 2:00 p.m.
Location: Baltimore, MD
Baltimore Convention Center
Level 100, Hall E/F
--- ---
Long-term Safety and
Efficacy of Adjunctive
Perampanel in Pediatric
Patients (Aged 4 to <12
Years) with Partial-
Onset Seizures or
Primary Generalized
Tonic-Clonic Seizures
in Study 311
Poster presentation number: 2.212
Robert Flamini, Anna Patten, Leock Y Ngo
Poster Session: 2
Time: Sunday, December 8
12:00 p.m. to 2:00 p.m.
Location: Baltimore, MD
Baltimore Convention Center
Level 100, Hall E/F
--- ---
Long-Term Effect of
Concomitant Enzyme-
Inducing Anti-Seizure
Drugs on the Safety and
Efficacy of Adjunctive
Perampanel in Patients
(Aged 4 to <12 Years)
with Partial-Onset
Seizures in Study 311
Poster presentation number: 2.228
Leock Y Ngo, Anna
Patten, Andras Fogarasi
Poster Session: 2
Time: Sunday, December 8
12:00 p.m. to 2:00 p.m.
Location: Baltimore, MD
Baltimore Convention Center
Level 100, Hall E/F
--- ---
Long-Term Adjunctive
Perampanel and Health-
Related Quality of Life
in Pediatric Patients
(Aged 4 to <12 Years)
with Partial-Onset
Seizures or Primary
Generalized Tonic-
Clonic Seizures in
Study 311
Poster presentation number: 3.302
Elena Arce Portillo,
Anna Patten, Genevieve
Meier, Manoj Malhotra,
Leock Y Ngo
Poster Session: 3
Time: Monday, December 9
12:00 p.m. to 2:00 p.m.
Location: Baltimore, MD
Baltimore Convention Center
Level 100, Hall E/F
--- ---
PROVE Study 506:
Retrospective, Phase IV
Study of Perampanel in
Real-World Clinical
Care of Patients Aged 4
to <12 Years with
Epilepsy
Poster presentation number: 3.303
Michael Chez, Anna
Patten, Manoj Malhotra
Poster Session: 3
Time: Monday, December 9
12:00 p.m. to 2:00 p.m.
Location: Baltimore, MD
Baltimore Convention Center
Level 100, Hall E/F
---
Long-Term Efficacy and
Safety of Adjunctive
Perampanel in Pediatric
Patients with Primary
Generalized Tonic-
Clonic Seizures of
Idiopathic Generalized
Epilepsy: Post Hoc
Analysis of Study 311
Poster presentation number: 3.306
Douglas R. Nordli Jr,
Alexis Arzimanoglou,
Anna Patten, Leock Y
Ngo
Poster Session: 3
Time: Monday, December 9
12:00 p.m. to 2:00 p.m.
Location: Baltimore, MD
Baltimore Convention Center
Level 100, Hall E/F
---
Safety and Efficacy
---
ELEVATE Study 410
Enrollment Update:
Phase IV Study of
Perampanel as
Monotherapy or First
Adjunctive Therapy in
Patients Aged >=12
Years with Partial-
Onset or Primary
Generalized Tonic-
Clonic Seizures
Poster presentation number: 1.303
Lynn Kramer, Pavel
Klein, Anna Patten,
Manoj Malhotra
Poster Session: 1
Time: Saturday, December 7
12:00 p.m. to 2:00 p.m.
Location: Baltimore, MD
Baltimore Convention Center
Level 100, Hall E/F
---
Efficacy and Safety of
Adjunctive Perampanel
for the Treatment of
Partial-Onset Seizures
(POS): Analysis of
Adult, Adolescent, and
Pediatric Populations
(Studies 304, 305, 306,
311)
Poster presentation number: 1.300
Gregory L Holmes,
Gregory L Krauss, Anna
Patten, Manoj Malhotra,
Leock Y Ngo
Poster Session: 1
Time: Saturday, December 7
12:00 p.m. to 2:00 p.m.
Location: Baltimore, MD
Baltimore Convention Center
Level 100, Hall E/F
--- ---
Adjunctive Perampanel
for Partial-Onset
Seizures: Post Hoc
Analysis of Treatment-
Emergent Adverse Events
(TEAEs) by Treatment
Period in Asia-Pacific
Study 335
Poster presentation number: 3.305
John M Stern, Dawn S
Eliashiv, Anna Patten,
Manoj Malhotra, Kimford
J Meador
Poster Session: 3
Time: 12:00 a.m. to 2:00 p.m.
Location: Baltimore, MD
Baltimore Convention Center
Level 100, Hall E/F
--- ---
Perampanel Monotherapy
in Patients (Pts) with
Newly Diagnosed or
Currently Untreated
Recurrent Partial-
Onset Seizures (POS):
Efficacy and Safety in
the Extension Phase of
Study 342 (FREEDOM)
Poster presentation number: 3.318
Yuichi Kubota, Ji-Hyun
Kim, Sung Chul Lim,
Hirotomo Ninomiya,
Takamichi Yamamoto,
Risa Matsunaga,
Hidetaka Hiramatsu,
Hiroyuki Higashiyama
Poster Session: 3
Time: Monday, December 9
12:00 p.m. to 2:00 p.m.
Location: Baltimore, MD
Baltimore Convention Center
Level 100, Hall E/F
--- ---
Efficacy and Safety of
Perampanel as First
Adjunctive Therapy in
Patients with Partial-
Onset Seizures: Post
Hoc Analysis of the
FAME Study by First-
Line Antiepileptic Drug
Use (Study 412)
Poster presentation number: 1.305
Dong Wook Kim, Hugh
Jiwoong Lee, Ji Hyun
Kim, Amitabh Dash
Poster Session: 1
Time: Saturday, December 7
12:00 p.m. to 2:00 p.m.
Location: Baltimore, MD
Baltimore Convention Center
Level 100, Hall E/F
---
Perampanel in Patients
with a History of
Psychiatric Illness:
Post Hoc Analysis of
Four Randomized Phase
III Studies (304, 305,
306, and 335) and their
Open-Label Extensions
(307 and 335 OLEx)
Poster presentation number: 2.214
Andres M Kanner, Anna
Patten, Manoj Malhotra
Poster Session: 2
Time: Sunday, December 8
12:00 p.m. to 2:00 p.m.
Location: Baltimore, MD
Baltimore Convention Center
Level 100, Hall E/F
--- ---
Adverse Event Profile
with Perampanel as
First Adjunctive
Therapy in Patients
with Partial-Onset
Seizures: Analysis of
the FAME Study (Study
412)
Poster presentation number: 2.216
Hugh Jiwoong Lee, Dong
Wook Kim, Ji-Hyun Kim,
Amitabh Dash
Poster Session: 2
Time: Sunday, December 8
12:00 p.m. to 2:00 p.m.
Location: Baltimore, MD
Baltimore Convention Center
Level 100, Hall E/F
--- ---
Adjunctive Perampanel
for Primary Generalized
Tonic-Clonic Seizures:
Post Hoc Analysis of
Treatment-Emergent
Adverse Events (TEAEs)
by Treatment Period in
Study 332
Poster presentation number: 2.220
Dawn S Eliashiv, John M
Stern, Anna Patten,
Manoj Malhotra, Kimford
J Meador
Poster Session: 2
Time: Sunday, December 8
12:00 p.m. to 2:00 p.m.
Location: Baltimore, MD
Baltimore Convention Center
Level 100, Hall E/F
--- ---
Adjunctive Perampanel
for Partial-Onset
Seizures: Pooled Post
Hoc Analysis of
Treatment-Emergent
Adverse Events (TEAEs)
by Treatment Period in
Studies 304, 305, and
306
Poster presentation number: 2.221
Manoj Malhotra, Anna
Patten, Kimford J
Meador
Poster Session: 2
Time: Sunday, December 8
12:00 p.m. to 2:00 p.m.
Location: Baltimore, MD
Baltimore Convention Center
Level 100, Hall E/F
---
Pooled Post Hoc Analysis
of Treatment-Emergent
Adverse Events (TEAEs)
by Treatment Period in
Patients Aged >=12 to
<18 and >=18 Years from
Studies 304, 305, 306,
335, and 332
Poster presentation number: 2.222
Sanjeev Kothare, Jay
Salpekar, Anna Patten,
Manoj Malhotra, Kimford
J Meador
Poster Session: 2
Time: Sunday, December 8
12:00 p.m. to 2:00 p.m.
Location: Baltimore, MD
Baltimore Convention Center
Level 100, Hall E/F
--- ---
Adjunctive Perampanel
for Partial-Onset
Seizures: Post Hoc
Analysis of Treatment-
Emergent Adverse Events
(TEAEs) by Treatment
Period in Asia-Pacific
Study 335
Poster presentation number: 3.305
John M Stern, Dawn S
Eliashiv, Anna Patten,
Manoj Malhotra, Kimford
J Meador
Poster Session: 3
Time: Monday, December 9
12:00 p.m. to 2:00 p.m.
Location: Baltimore, MD
Baltimore Convention Center
Level 100, Hall E/F
--- ---
Post-Marketing
Observational Study to
Evaluate Safety and
Tolerability of
Perampanel as Add-On
Therapy in Patients
with Epilepsy: Post Hoc
Analysis by Dose and
Enzyme-Inducing Anti-
Seizure Drugs (Study
402)
Poster presentation number: 3.313
Anna Patten, Leock Y Ngo
Poster Session: 3
Time: Monday, December 9
12:00 p.m. to 2:00 p.m.
Location: Baltimore, MD
Baltimore Convention Center
Level 100, Hall E/F
--- ---
Effect of Perampanel on
Hyperthermia-Induced
Seizures in a Dravet
Syndrome Mouse Model
Poster presentation number: 2.198
Nicholas S. Roberts,
Yoshimasa Ito, Delia M.
Talos, Frances E.
Jensen
Poster Session: 2
Time: Sunday, December 8
12:00 p.m. to 2:00 p.m.
Location: Baltimore, MD
Baltimore Convention Center
Level 100, Hall E/F
--- ---
Safety and Efficacy of
Long-Term Treatment
with Perampanel in
Japanese Patients with
Partial-Onset Seizures
or Primary Generalized
Tonic-Clonic Seizures
in a Real-World Setting
Poster presentation number: 3.329
Takuji Nishida, Yushi
Inoue, Kenta Sumitomo,
Kazuhiro Matsutani, Mika
Ishii
Poster Session: 3
Time: Monday, December 9
12:00 p.m. to 2:00 p.m.
Location: Baltimore, MD
Baltimore Convention Center
Level 100, Hall E/F
---
HEOR Data
---
Real-World Healthcare
Resource Utilization of
Patients Treated with
Antiepileptic Drug
Combinations with
Versus without
Perampanel in the
United States
Poster presentation number: 2.238
François Laliberté,
Jiyoon Choi, Mei Sheng
Duh, Victoria Barghout,
Guillaume Germain,
Cristi Cavanaugh,
Dominique Lejeune,
Russell Knoth, Edward
Faught
Poster Session: 2
Time: Sunday, December 8
12:00 p.m. to 2:00 p.m.
Location: Baltimore, MD
Baltimore Convention Center
Level 100, Hall E/F
--- ---
Estimating the Budget
Impact of Increased
Utilization of
Perampanel to Treat
Adult and Pediatric
Patients Diagnosed with
Epilepsy
Poster presentation number: 3.410
Ibrahim Khilfeh, Jackie
Lee, Jesse Ortendahl,
Russell Knoth
Poster Session: 3
Time: Monday, December 9
12:00 p.m. to 2:00 p.m.
Location: Baltimore, MD
Baltimore Convention Center
Level 100, Hall E/F
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Portions of this release discuss investigational uses for an FDA-approved product. It is not intended to convey conclusions about efficacy or safety. There is no guarantee that any investigational uses of such product 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.).
Media Inquiries:
James Merse
Eisai Inc.
551-502-2710
James_Merse@eisai.com
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