WOODCLIFF LAKE, N.J., Dec. 1, 2021 /PRNewswire/ -- Eisai Inc. announced today that new data on its antiepileptic drug FYCOMPA® (perampanel) CIII will be presented at the 75th American Epilepsy Society (AES) Annual Meeting to be held from December 3 to December 7, 2021 in Chicago, Il. Eisai will present 42 posters including key early add-on FYCOMPA data as well as data in pediatric and elderly patients. Three posters will present data on E2730, a selective uncompetitive GAT-1 Inhibitor, underscoring the company's commitment to advance epilepsy research as part of its mission to help treat patients living with epilepsy.
Key data to be presented include:
"We are pleased to share data from multiple studies assessing FYCOMPA in a real-world clinical setting, including monotherapy and as an early add-on therapy, as well as seizure reduction and freedom rates across a variety of patient and seizure types at this year's meeting of the American Epilepsy Society," said Ivan Cheung, Chairman, Eisai Inc. and Global President, Neurology Business Group, Eisai Co., Ltd. "At Eisai we continuously work with healthcare providers, caregivers, and patients to better understand the challenges patients with epilepsy experience. These data encourage us to continue our important research to advance our understanding of epilepsy and its treatment."
In September 2018, FYCOMPA was approved by the FDA 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 the United States and Europe and has been used to treat more than 410,000 patients worldwide across all indications.
The following are key studies that will be presented by Eisai at this year's AES Annual Meeting:
Note: Posters will be available at the press room for the duration of the meeting and remain available for 90 days.
Poster Name | Session (All Times Central) |
PERAMPANEL | |
Interim Safety and Efficacy Data of Adjunctive Perampanel in Pediatric Patients (Aged ≥ 1 – < 24 Months) with Epilepsy in Study 238 by Age
J Ben Renfroe, Guntis Rozentals, Gleb Filippov, Dinesh Kumar, Leock Y Ngo | Poster Session: #2.265 Date: Sunday, December 5, 2021 Presentation Time: 12:00 PM – 2:00 PM CST Presentation Format: Live |
Interim Safety Data of Adjunctive Perampanel in Patients (Aged ≥ 1 to < 24 Months) with Epilepsy in Study 238: Treatment-Emergent Adverse Events (TEAEs) of Interest and Serious TEAEs Case Studies
Gautam S Popli, Guntis Rozentals, Gleb Filippov, Dinesh Kumar, Leock Y Ngo | Poster Session #: 3.255 Date: Monday, December 6, 2021 Presentation Time: 12:00 PM - 1:45 PM CST Presentation Format: Live |
Adjunctive Perampanel in Pediatric Patients (Aged ≥ 1 – < 24 Months) with Epilepsy in Study 238: Interim Safety Parameter Data
Muhammad Zafar, Guntis Rozentals, Gleb Filippov, Dinesh Kumar, Leock Y Ngo | Poster Session #: V.068 Virtual Presentation Date & Time: Thursday, December 9, 2021 11:00 AM - 12:00 PM CST Presentation Format: Virtual |
Long-Term (52 Weeks) Evaluation of Adjunctive Perampanel on Mental Health in Pediatric Japanese Patients with Focal-Onset Seizures (FOS) in Study 311
Hiroo Omatsu, Toshihide Watanabe, Ryutaro Kira, Jun Tohyama, Hideaki Shiraishi, Katsuhiro Kobayashi, Kaeko Ishiba, Leock Y Ngo, Anna Patten, Takao Takase | Poster Session #: 3.282 Virtual Presentation Date & Time: Thursday, December 9, 2021 4:00 PM - 5:00 PM CST Presentation Format: Virtual |
Perampanel for the Treatment of Pediatric Patients in Clinical Practice by Age Category
Stéphane Auvin, Adrián Garcia-Ron, Anita Datta, Tony Wu, Wendyl D´Souza, Leock Y Ngo, Vicente Villanueva | Poster Session #: 3.219 Date: Monday, December 6, 2021 Presentation Time: 12:00 PM - 1:45 PM CST Presentation Format: Live |
ELEVATE Study 410: Phase IV Study of Perampanel as Monotherapy or First Adjunctive Therapy in Patients Aged ≥ 4 Years with Focal-Onset Seizures (FOS) or Generalized Tonic- Clonic Seizures (GTCS) Pavel Klein, Omar Samad, Dinesh Kumar, Leock Y Ngo, Manoj Malhotra | Poster Session: #: 3.270 Date: Monday, December 6, 2021 Presentation Time: 12:00 PM – 1:45 PM CST Presentation Format: Live |
ELEVATE Study 410: Perampanel As Monotherapy or First Adjunctive Therapy in Patients with Focal-Onset Seizures (FOS) or Generalized Tonic-Clonic Seizures (GTCS): Analysis by Patient Age
Vineet Punia, Omar Samad, Dinesh Kumar, Leock Y Ngo, Manoj Malhotra | Poster Session: #2.216 Date: Sunday, December 5, 2021 Presentation Time: 12:00 PM – 2:00 PM CST Presentation Format: Live |
Assessment of Cognition (EpiTrack®) and Depression (Beck Depression Inventory-II) Following Perampanel (Monotherapy/First Adjunctive) in Patients with Epilepsy Enrolled in the ELEVATE Phase IV Study
Joon Y Kang, Omar Samad, Dinesh Kumar, Leock Y Ngo, Manoj Malhotra | Poster Session #: 2.208 Virtual Presentation Date & Time: Thursday, December 9, 2021 10:00 AM - 11:00 AM CST Presentation Format: Virtual |
ELEVATE Study 410: Phase IV Study of Perampanel as Monotherapy or First Adjunctive Therapy in Patients Aged ≥ 4 Years with Epilepsy: Quality of Life and Sleep Results
Victor Biton, Omar Samad, Dinesh Kumar, Leock Y Ngo, Manoj Malhotra | Poster Session #: V.065 Virtual Presentation Date & Time: Thursday, December 9, 2021 4:00 PM - 5:00 PM CST Presentation Format: Virtual |
Use of the Columbia-Suicide Severity Rating Scale to Evaluate Suicidality Among Patients with Focal-Onset or Generalized Tonic- Clonic Seizures Enrolled onto the Perampanel ELEVATE 410 Phase IV Study
Rubina Bakerywala, Omar Samad, Dinesh Kumar, Leock Y Ngo, Manoj Malhotra | Poster Session: #1.285 Date: Saturday, December 4, 2021 Presentation Time: 12:00 PM – 2:00 PM CST Presentation Format: Live |
Safety of Perampanel (Monotherapy/First Adjunctive) by Titration and Maintenance Periods in Patients with Focal-Onset or Generalized Tonic-Clonic Seizures: Results From the Phase IV ELEVATE Study
Joanne Rogin, Omar Samad, Dinesh Kumar, Leock Y Ngo, Manoj Malhotra | Poster Session: #1.284 Date: Saturday, December 4, 2021 Presentation Time: 12:00 PM – 2:00 PM CST Presentation Format: Live |
Study 505, a Post-Marketing Surveillance Study of Perampanel Film-Coated Tablets and Oral Suspension in Korean Patients: Study Design
Sang Kun Lee, Ji Hyun Kim, Dae-Won Seo, Dong Wook Kim, Minhee Lee, Seung Bong Hong, Kyoung Heo | Poster Session #: 3.272 Virtual Presentation Date & Time: Thursday, December 9, 2021 4:00 PM - 5:00 PM CST Presentation Format: Virtual |
Long-Term Efficacy and Safety of Perampanel Monotherapy in Patients with Newly Diagnosed/Currently Untreated Recurrent Focal-Onset Seizures (FOS): FREEDOM Study 342 Extension Phase
Takamichi Yamamoto, Sung Chul Lim, Hirotomo Ninomiya, Yuichi Kubota, Won Chul Shin, Dong Wook Kim, Dong Jin Shin, Tohru Hoshida, Koji Iida, Taku Ochiai, Risa Matsunaga, Hidetaka Hiramatsu, Ji Hyun Kim | Poster Session #: 1.283 Virtual Presentation Date & Time: Thursday, December 9, 2021 10:00 AM - 11:00 AM CST Presentation Format: Virtual |
Perampanel Plasma Concentrations and Clinical Effects Following 8-mg/day Monotherapy in Patients with Focal-Onset Seizures (FOS): Post Hoc Analysis of Study 342 (FREEDOM)
Hirotomo Ninomiya, Ji Hyun Kim, Sung Chul Lim, Yuichi Kubota, Takamichi Yamamoto, Risa Matsunaga, Leock Y Ngo, Anna Patten, Hidetaka Hiramatsu, Manoj Malhotra, Ilo E Leppik | Poster Session #: 1.295 Virtual Presentation Date & Time: Thursday, December 9, 2021 10:00 AM - 11:00 AM CST Presentation Format: Virtual |
Long-Term Perampanel Monotherapy and Health-Related Quality of Life in Patients with Newly Diagnosed/Currently Untreated Recurrent Focal-Onset Seizures (FOS): FREEDOM Study 342 Extension Phase
Ji Hyun Kim, Takamichi Yamamoto, Sung Chul Lim, Hirotomo Ninomiya, Yuichi Kubota, Anna Patten, Leock Y Ngo, Manoj Malhotra | Poster Session: #2.201 Date: Sunday, December 5, 2021 Presentation Time: 12:00 PM – 2:00 PM CST Presentation Format: Live |
Perampanel Monotherapy for Focal-Onset Seizures (FOS): Post Hoc Analysis of Treatment-Emergent Adverse Events (TEAEs) by Treatment Period During FREEDOM Study 342
Yuichi Kubota, Ji Hyun Kim, Sung Chul Lim, Hirotomo Ninomiya, Takamichi Yamamoto, Anna Patten, Leock Y Ngo, Manoj Malhotra | Poster Session #: 1.294 Virtual Presentation Date & Time: Thursday, December 9, 2021 11:00 AM - 12:00 PM CST Presentation Format: Virtual |
Effectiveness, Safety and Tolerability of Perampanel in Adolescents with Focal-Onset and Generalized-Onset Seizures: Evidence from Clinical Practice
Francisco José Gil-López, Rohit Shankar, Takamichi Yamamoto, Javier Montoya, Eugen Trinka, Wendyl D'Souza, Takaya Maeda, Vicente Villanueva | Poster Session #: V.051 Virtual Presentation Date & Time: Thursday, December 9, 2021 4:00 PM - 5:00 PM CST Presentation Format: Virtual |
Pooled Analysis of Adult Epilepsy Patients Treated with Perampanel in Everyday Clinical Practice
Adam Strzelczyk, Tim Wehner, Francesco Deleo, Mar Carreño, Eugen Trinka, Tony Wu, Amitabh Dash, Bernhard J. Steinhoff, Vicente Villanueva | Poster Session #: V.052 Virtual Presentation Date & Time: Thursday, December 9, 2021 4:00 PM - 5:00 PM CST Presentation Format: Virtual |
The Use of Perampanel in Elderly Epilepsy Patients: Pooled Analysis of Real-World Studies
Motoki Inaji, Rob McMurray, Alexandra Rohracher, Dong Wook Kim, Juan Jesús Rodriguez-Uranga, Wendyl D'Souza, Eugen Trinka, Claudio Liguori, Vicente Villanueva | Poster Session #: 1.215 Date: Saturday December 4, 2021 Presentation Time: 12:00 PM - 2:00 PM CST Presentation Format: Live |
Real-World Experience of Perampanel Monotherapy in Epilepsy Patients with Focal-Onset and Generalized-Onset Seizures
Taoufik Alsaadi, Manuel Toledo, Fernando Ayuga Loro, Eugen Trinka, Tony Wu, Manoj Malhotra, Leock Y Ngo, Antonio Gil-Nagel, Vicente Villanueva | Poster Session #: V.043 Virtual Presentation Date & Time: Thursday, December 9, 2021 10:00 AM - 11:00 AM CST Presentation Format: Virtual |
Clinical Practice Evidence for Perampanel in Epilepsy Patients with Tumor Etiology
Antonietta Coppola, Shuichi Izumoto, Xiana Rodríguez-Osorio, Tony Wu, Wendyl D'Souza, Marta Maschio; Samantha Goldman, Mariana Valente Fernandes, Vicente Villanueva | Poster Session #: 3.211 Date: Thursday, December 9, 2021 Presentation Time: 10:00 AM -11:00 AM CST Presentation Format: Virtual |
Perampanel as Early Add-on Therapy for Epilepsy Patients with Focal-Onset and Generalized-Onset Seizures Treated in Clinical Practice
Estevo Santamarina, Javier Abril-Jaramillo, Xiana Rodriguez- Osorio, Takamichi Yamamoto, Rob McMurray, Eugen Trinka, Wendyl D'Souza, Rosaria Renna, Vicente Villanueva | Poster Session #: 3.213 Date: Monday, December 6, 2021 Presentation Time: 12:00 PM -1:45 PM CST Presentation Format: Live |
Perampanel for the Treatment of Patients with Idiopathic Generalized Epilepsy in Clinical Practice
Eugen Trinka, Rajiv Mohanraj, Takaya Maeda, Imad Najm, Wendyl D'Souza, Vicente Villanueva | Poster Session #: 3.216 Date: Monday December 6, 2021 Presentation Time: 12:00 PM - 1:45 PM CST Presentation Format: Live |
Perampanel for the Treatment of Patients with Lennox-Gastaut Syndrome in Clinical Practice
Paolo Bonanni, Carlo Di Bonaventura, Wendyl D'Souza, Tony Wu, Rob McMurray, Vicente Villanueva | Poster Session #: 2.107 Virtual Presentation Date & Time: Thursday, December 9, 2021 10:00 AM - 11:00 AM CST Presentation Format: Virtual |
Perampanel for the Treatment of Epilepsy Patients with Intellectual Disability in Clinical Practice
Paola De Liso, Tony Wu, Julia Jacobs-LeVan, Iñigo Garamendi- Ruiz, Rob McMurray, Vicente Villanueva | Poster Session #: V.064 Virtual Presentation Date & Time: Thursday, December 9, 2021 10:00 AM - 11:00 AM CST Presentation Format: Virtual |
Perampanel for the Treatment of Patients with Myoclonic Seizures in Clinical Practice
Hsing-I Chiang, Rodrigo Rocamora, Ascension Castillo, Eugen Trinka, Wendyl D'Souza, Samantha Goldman, Vicente Villanueva | Poster Session #: V.065 Virtual Presentation Date & Time: Thursday, December 9, 2021 4:00 PM - 5:00 PM CST Presentation Format: Virtual |
Real-World Evidence on the Use of Perampanel for the Treatment of Epilepsy Patients with Vascular Etiology
Rafael Toledano Delgado, Luis Morillo, Pavel Vlasov, Eugen Trinka, Samantha Goldman, Vicente Villanueva | Poster Session #: V.053 Virtual Presentation Date & Time: Thursday, December 9, 2021 10:00 AM - 11:00 AM CST Presentation Format: Virtual |
Final Results of A Mirroring Clinical Practice Study of Perampanel in Adults and Adolescents (AMPA): A Real-Life, Observational Study of Adjunctive Perampanel for Focal-Onset Seizures
Anna Gentile, Giancarlo Di Gennaro, Alfredo D'Aniello, Samantha Goldman, Anna Patten, Martina Chiacchiaretta | Poster Session #: V.064 Virtual Presentation Date & Time: Thursday, December 9, 2021 10:00 AM - 11:00 AM CST Presentation Format: Virtual |
Effect of Low Dose (4 mg/day) Perampanel on Efficacy and Safety Outcomes from A Mirroring Clinical Practice Study of Adjunctive Perampanel in Adults and Adolescents (AMPA) with Focal-Onset Seizures
Anna Teresa Giallonardo, Umberto Aguglia, Samantha Goldman, Martina Chiacchiaretta, Anna Gentile, Anna Patten | Poster Session #: 1.292 Virtual Presentation Date & Time: Thursday, December 9, 2021 10:00 AM - 11:00 AM CST Presentation Format: Virtual |
Effect of Age on Efficacy and Safety Outcomes from A Mirroring Clinical Practice Study of Perampanel in Adults and Adolescents (AMPA)
Oriano Mecarelli, Samantha Goldman, Anna Patten, Martina Chiacchiaretta, Anna Gentile | Poster Session #: 1.289 Virtual Presentation Date & Time: Thursday, December 9, 2021 11:00 AM - 12:00 PM CST Presentation Format: Virtual |
A Mirroring Clinical Practice Study of Perampanel in Adults and Adolescents (AMPA): Assessment of the Impact of Perampanel on Quality of Life (QoL) and Sleep in Patients with Focal-Onset Seizures
Giovanni Assenza, Antonio Gambardella, Samantha Goldman, Anna Patten, Martina Chiacchiaretta, Anna Gentile | Poster Session #: 1.282 Virtual Presentation Date & Time: Thursday, December 9, 2021 11:00 AM - 12:00 PM CST Presentation Format: Virtual |
Safety and Efficacy of Perampanel as First Adjunctive Therapy in Patients with Focal-Onset Seizures (FOS) or Generalized Tonic- Clonic Seizures (GTCS): Results from Studies 412, 501, and 410
Dong Wook Kim, Stefano Meletti, Vineet Punia, Dinesh Kumar, Anna Gentile, Samantha Goldman, Manoj Malhotra, Omar Samad, Amitabh Dash, Ji Woong Lee | Poster Session #: V.067 Virtual Presentation Date & Time: Thursday, December 9, 2021 11:00 AM - 12:00 PM CST Presentation Format: Virtual |
Perampanel for the Treatment of Focal-Onset and Generalized- Onset Seizures in Patients with Post-Traumatic Brain Injury Etiology: Evidence from Clinical Practice
Yotin Chinvarun, Chen-Jui Ho, Galina Odintsova, Wendyl D'Souza, Eugen Trinka, Manoj Malhotra, Vicente Villanueva | Poster Session #: 2.109 Virtual Presentation Date & Time: Thursday, December 9, 2021 10:00 AM - 11:00 AM CST Presentation Format: Virtual |
Real-World Evidence on the Safety and Efficacy of Adjunctive Perampanel Across Different Geographical Regions from Three Phase IV Studies: Studies 506, 508, and 501
Robert T Wechsler, Antonietta Coppola, Anshu Rohatgi, Anna Patten, Samantha Goldman, Anna Gentile, Balaji Patil, Amitabh Dash, Leock Y Ngo, Manoj Malhotra | Poster Session #: 3.276 Date: Monday, December 6, 2021 Presentation Time: 12:00 PM - 1:45 PM CST Presentation Format: Live |
Long-Term Seizure Freedom with Adjunctive Perampanel in Patients with Focal-Onset and Focal to Bilateral Tonic-Clonic Seizures: Post Hoc Analysis of Study 335 Open-Label Extension (OLEx)
Manoj Malhotra, Takuji Nishida, Sang Kun Lee, Yushi Inoue, Kazunori Saeki, Kohei Ishikawa, Anna Patten, Sunao Kaneko | Poster Session #: 2.202 Virtual Presentation Date & Time: Thursday, December 9, 2021 10:00 AM - 11:00 AM CST Presentation Format: Virtual |
Efficacy and Safety of Perampanel in Asian Patients: Evaluating Data from Five Phase III or IV Studies
Amitabh Dash, Hiroo Omatsu, Takamichi Yamamoto, Sunao Kaneko, Dong Wook Kim, Anshu Rohatgi, Rahul Kulkarni, Ji Woong Lee, Balaji Patil, Anna Patten, Leock Y Ngo, Manoj Malhotra | Poster Session #: V.066 Virtual Presentation Date & Time: Thursday, December 9, 2021 10:00 AM - 11:00 AM CST Presentation Format: Virtual |
Perampanel in Elderly Patients: An Overview of Data from Studies 307, 335, 412, 342, and 506
Ilo E Leppik, Robert T Wechsler, Dae-Won Seo, Takamichi Yamamoto, Anna Patten, Ji Woong Lee, Leock Y Ngo, Manoj Malhotra | Poster Session #: 2.218 Date: Sunday, December 5, 2021 Presentation Time: 12:00 PM - 2:00 PM CST Presentation Format: Live |
Design of Study 236: A Phase II, Multicenter, Open-Label, Single- Arm Study of Adjunctive Perampanel in Patients (Aged 1 Month–< 18 Years) with Childhood Epilepsy
Eric Segal, Sergio Aguilera-Albesa, Gleb Filippov, Anna Patten, Leock Y Ngo | Poster Session #: V.071 Virtual Presentation Date & Time: Thursday, December 9, 2021 11:00 AM - 12:00 PM CST Presentation Format: Virtual |
Real-world impact of perampanel use among patients diagnosed with epilepsy in the United States
Brian D. Moseley; Jonathon Wright, Shaloo Gupta, Victoria Barghout, Nate Way, John C. Rowland, Craig Plauschinat, Feride Frech | Poster Session #: 3.305 Date: Monday, December 6, 2021 Presentation Time: 12:00 PM - 1:45 PM CST Presentation Format: Live |
NAMI | |
Discovery of E2730, A Novel Selective Uncompetitive GAT-1 Inhibitor: In Vivo Characteristics
Kazuyuki Fukushima, Hiroyuki Higashiyama, Yuji Kazuta, Keisuke Hashimoto, Yoshiaki Furuya, Yoshimasa Ito, Ting Wu, Takashi Kosasa, Delia M. Talos, Nicholas S. Roberts, Frances E. Jensen, Takahisa Hanada, Katsutoshi Ido | Poster Session #: 2.197 Date: Sunday, December 5, 2021 Presentation Time: 12:00 PM - 2:00 PM CST Presentation Format: Live |
Discovery of E2730, A Novel Selective Uncompetitive GAT-1 Inhibitor: In Vitro Characteristics
Kazuyuki Fukushima, Hiroyuki Higashiyama, Yuji Kazuta, Keisuke Hashimoto, Naoto Watanabe, Takahisa Hanada, Katsutoshi Ido | Poster Session #: 3.301 Date: Monday, December 6, 2021 Presentation Time: 12:00 PM - 1:45 PM CST Presentation Format: Live |
E2730, a GABA transporter-1 inhibitor, suppresses epileptic seizures in a rat model of chronic drug resistant mesial temporal lobe epilepsy
Idrish Ali, Juliana Silva, Pablo Casillas-Espinosa, Emma Braine, Glenn Yamanaka, Matthew R. Hudson, Rhys D. Brady, Brendan Major, David Wright, Bianca Jupp, Lucy Vivash, Sandy R. Shultz, Richelle Mychasiuk, Patrick Kwan, Nigel C. Jones, Kazuyuki Fukushima, Pallavi Sachdev, Terence J. O'Brien | Poster Session #: V.063 Virtual Presentation Date & Time: Thursday, December 9, 2021 4:00 PM - 5:00 PM CST Presentation Format: Virtual |
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 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.).
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