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, 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:
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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
Takamichi Yamamoto, Ji-Hyun Kim, Sung Chul Lim, Hirotomo Ninomiya, Yuichi Kubota, Risa Matsunaga, Hidetaka Hiramatsu, Hiroyuki Higashiyama |
Poster presentation number: 2.215
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 |
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Real-world Use |
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PROVE Study 506: Retrospective, Phase IV Study of Perampanel in Real-World Clinical Care of Patients Aged 12 to <18 Years with Epilepsy
Patricia Penovich, Eric Segal, Anna Patten, Manoj Malhotra |
Poster presentation number: 2.209
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 |
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PROVE Study 506: Perampanel as Adjunctive Therapy or Monotherapy in Real-World Clinical Care of Patients with Epilepsy
Ruben Kuzniecky, Robert T Wechsler, Anna Patten, Manoj Malhotra |
Poster presentation number: 1.304
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 |
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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
Saurabh R Sinha, Selim Benbadis, Muhammad Zafar, Anna Patten, Manoj Malhotra |
Poster presentation number: 1.306
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 |
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PROVE Study 506: Retrospective, Phase IV Study of Perampanel in Real-World Clinical Care of Patients Aged ≥18 Years with Epilepsy
Alejandro Salah, Anna Patten, Manoj Malhotra |
Poster presentation number: 1.311
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 |
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Perampanel in Real-World Clinical Care of Patients with Epilepsy: Results from the Retrospective, Phase IV PROVE Study 506
James Wheless, Anna Patten, Manoj Malhotra |
Poster presentation number: 1.312
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 |
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PROVE Study 506: Retrospective, Phase IV Study of Perampanel in Real-World Clinical Care of Patients Aged <4 Years with Epilepsy
Muhammad Zafar, Anna Patten, Manoj Malhotra |
Poster presentation number: 1.313
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 |
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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
Sami Aboumatar, Anna Patten, Manoj Malhotra |
Poster presentation number: 3.301
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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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
Graham Huesmann, Anna Patten, Manoj Malhotra |
Poster presentation number: 3.307
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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Perampanel in Real-World Clinical Care of Patients with Epilepsy at Idaho Comprehensive Epilepsy Center: A Regional Comparison of Results from PROVE Study 506
Robert T Wechsler, Anna Patten, Manoj Malhotra |
Poster presentation number: 3.308
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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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
Trevor Resnick, James Wheless, Anna Patten, Manoj Malhotra |
Poster presentation number: 3.315
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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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
Hyunmi Choi, Eric Segal, Anna Patten, Manoj Malhotra |
Poster presentation number: 3.316
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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Pediatric Data |
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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
Steven Phillips, Anna Patten, Leock Y Ngo |
Poster presentation number: 3.311
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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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
Barry Gidal, Kimford J Meador, Anna Patten, Manoj Malhotra, Leock Y Ngo |
Poster presentation number: 1.315
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 |
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Perampanel Exposure–Response Relationships for Cognition and Safety in Pediatric Patients (Aged 4 to <12 years) with Epilepsy (study 311, 232)
Oneeb Majid, Larisa Reyderman, Jim Ferry, Ziad Hussein |
Poster presentation number: 2.207
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 |
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Effect of Concomitant Anti-Seizure Drugs During Adjunctive Perampanel Treatment in Pediatric Patients (Aged 4 to <12 Years): Post Hoc Analysis of Study 311
Andras Fogarasi, Anna Patten, Leock Y Ngo |
Poster presentation number: 2.208
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 |
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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)
Gregory L Krauss, Anna Patten, Manoj Malhotra, Leock Y Ngo |
Poster presentation number: 2.210
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 |
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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
J Ben Renfroe, Anna Patten, Manoj Malhotra, Leock Y Ngo |
Poster presentation number: 2.211
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 |
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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 Robert Flamini, Anna Patten, Leock Y Ngo |
Poster presentation number: 2.212
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 |
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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
Leock Y Ngo, Anna Patten, Andras Fogarasi |
Poster presentation number: 2.228
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 |
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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
Elena Arce Portillo, Anna Patten, Genevieve Meier, Manoj Malhotra, Leock Y Ngo |
Poster presentation number: 3.302
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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PROVE Study 506: Retrospective, Phase IV Study of Perampanel in Real-World Clinical Care of Patients Aged 4 to <12 Years with Epilepsy
Michael Chez, Anna Patten, Manoj Malhotra |
Poster presentation number: 3.303
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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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
Douglas R. Nordli Jr, Alexis Arzimanoglou, Anna Patten, Leock Y Ngo |
Poster presentation number: 3.306
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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Safety and Efficacy |
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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
Lynn Kramer, Pavel Klein, Anna Patten, Manoj Malhotra |
Poster presentation number: 1.303
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 |
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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)
Gregory L Holmes, Gregory L Krauss, Anna Patten, Manoj Malhotra, Leock Y Ngo |
Poster presentation number: 1.300
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 |
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Adjunctive Perampanel for Partial-Onset Seizures: Post Hoc Analysis of Treatment-Emergent Adverse Events (TEAEs) by Treatment Period in Asia-Pacific Study 335
John M Stern, Dawn S Eliashiv, Anna Patten, Manoj Malhotra, Kimford J Meador |
Poster presentation number: 3.305
Poster Session: 3 Time: 12:00 a.m. to 2:00 p.m.
Location: Baltimore, MD Baltimore Convention Center Level 100, Hall E/F |
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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)
Yuichi Kubota, Ji-Hyun Kim, Sung Chul Lim, Hirotomo Ninomiya, Takamichi Yamamoto, Risa Matsunaga, Hidetaka Hiramatsu, Hiroyuki Higashiyama |
Poster presentation number: 3.318
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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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)
Dong Wook Kim, Hugh Jiwoong Lee, Ji Hyun Kim, Amitabh Dash |
Poster presentation number: 1.305
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 |
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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)
Andres M Kanner, Anna Patten, Manoj Malhotra |
Poster presentation number: 2.214
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 |
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Adverse Event Profile with Perampanel as First Adjunctive Therapy in Patients with Partial-Onset Seizures: Analysis of the FAME Study (Study 412)
Hugh Jiwoong Lee, Dong Wook Kim, Ji-Hyun Kim, Amitabh Dash |
Poster presentation number: 2.216
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 |
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Adjunctive Perampanel for Primary Generalized Tonic-Clonic Seizures: Post Hoc Analysis of Treatment-Emergent Adverse Events (TEAEs) by Treatment Period in Study 332
Dawn S Eliashiv, John M Stern, Anna Patten, Manoj Malhotra, Kimford J Meador |
Poster presentation number: 2.220
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 |
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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
Manoj Malhotra, Anna Patten, Kimford J Meador |
Poster presentation number: 2.221
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 |
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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
Sanjeev Kothare, Jay Salpekar, Anna Patten, Manoj Malhotra, Kimford J Meador |
Poster presentation number: 2.222
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 |
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Adjunctive Perampanel for Partial-Onset Seizures: Post Hoc Analysis of Treatment-Emergent Adverse Events (TEAEs) by Treatment Period in Asia-Pacific Study 335
John M Stern, Dawn S Eliashiv, Anna Patten, Manoj Malhotra, Kimford J Meador |
Poster presentation number: 3.305
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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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)
Anna Patten, Leock Y Ngo |
Poster presentation number: 3.313
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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Effect of Perampanel on Hyperthermia-Induced Seizures in a Dravet Syndrome Mouse Model
Nicholas S. Roberts, Yoshimasa Ito, Delia M. Talos, Frances E. Jensen |
Poster presentation number: 2.198
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
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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
Takuji Nishida, Yushi Inoue, Kenta Sumitomo, Kazuhiro Matsutani, Mika Ishii |
Poster presentation number: 3.329
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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HEOR Data |
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Real-World Healthcare Resource Utilization of Patients Treated with Antiepileptic Drug Combinations with Versus without Perampanel in the United States
François Laliberté, Jiyoon Choi, Mei Sheng Duh, Victoria Barghout, Guillaume Germain, Cristi Cavanaugh, Dominique Lejeune, Russell Knoth, Edward Faught |
Poster presentation number: 2.238
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 |
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Estimating the Budget Impact of Increased Utilization of Perampanel to Treat Adult and Pediatric Patients Diagnosed with Epilepsy
Ibrahim Khilfeh, Jackie Lee, Jesse Ortendahl, Russell Knoth |
Poster presentation number: 3.410
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 |
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
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WARNING: SERIOUS PSYCHIATRIC AND BEHAVIORAL REACTIONS |
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- 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 |
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
SOURCE Eisai Inc.
Type Press Release
Date Released November 25, 2019