Eisai To Present FYCOMPA Long-Term Sustained Seizure Freedom And Pediatric Data At Upcoming American Epilepsy Society Annual Meeting

WOODCLIFF LAKE, N.J., Nov. 21, 2018 /PRNewswire/ -- Eisai Inc. today announced that it will present FYCOMPA(®) (perampanel) CIII long-term seizure freedom and pediatric data at the upcoming American Epilepsy Society Annual Meeting taking place from November 30 to December 4 in New Orleans. More than 50 scientific posters on perampanel will be presented at the meeting by both Eisai and independent investigators, underscoring a collective commitment to advancing research in epilepsy care and treatment.

Other data to be presented include an analysis of inpatient hospitalization rates for FYCOMPA vs. lacosamide, real-world clinical care with FYCOMPA, and the effect of FYCOMPA on quality of life.

"We are excited to showcase the broad range of FYCOMPA data," said Lynn Kramer, M.D., Chief Clinical Officer and Chief Medical Officer, Neurology Business Group, Eisai. "This includes both long-term seizure freedom data and the studies that supported our recent FDA approval in pediatric patients 4 years and older for the treatment of partial-onset seizures (POS). At Eisai, we continue to focus on providing tools that help patients and clinicians work toward the ultimate goal of seizure freedom."

On September 28, 2018, the U.S. Food and Drug Administration (FDA) expanded the indication of FYCOMPA for monotherapy and adjunctive use in pediatric patients 4 years and older for the treatment of partial-onset seizures (POS) with or without secondarily generalized seizures. The approval includes both the FYCOMPA tablet and oral suspension formulations. FYCOMPA is approved in 55 countries and has been prescribed to more than 200,000 patients worldwide across all indications.

Additionally, Eisai will host "Research Updates From Eisai" on December 2 from 8:00am-11:00am in Room 282, at the Ernest N. Morial Convention Center. This event will feature all 21 of Eisai's posters as well as select posters from Investigator-Initiated Studies (IIS).

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 Pacific)

                      ---                                        ---


       
              Convulsive Seizure Freedom

    ---

        Sustained seizure-free
         status with adjunctive
         perampanel (PER) for
         patients with secondarily
         generalized (SG) seizures
         during an open-label
         extension (OLEx): Study
         307                                   
       Poster presentation number: 2.255



                   Trevor Resnick, Anna
                    Patten, Manoj Malhotra,
                    Leock Y Ngo, Betsy
                    Williams                   
       Poster Session: 2



                                               
       Time: Sunday, December 2

                                               
       12:00 p.m. to 2:00 p.m.



                                               
       Location: New Orleans, LA

                                                   Ernest N. Morial Convention Center, on the First Floor, Hall H

    ---                                        ---

        Sustained seizure-free
         status with adjunctive
         perampanel for patients
         with primary generalized
         tonic-clonic (PGTC)
         seizures during the Open-
         label Extension (OLEx)
         Phase of Study 332                    
       Poster presentation number: 2.256



                   Imad M Najm, Manoj
                    Malhotra, Anna Patten,
                    Leock Y Ngo, Betsy
                    Williams                   
       Poster Session: 2



                                               
       Time: Sunday, December 2

                                               
       12:00 p.m. to 2:00 p.m.



                                               
       Location: New Orleans, LA

                                                   Ernest N. Morial Convention Center, on the First Floor, Hall H

    ---                                        ---

        Adjunctive perampanel (PER)
         and myoclonic and absence
         seizures: post hoc
         analysis of seizure days
         and seizure-free days in
         Study 332                             
       Poster presentation number: 2.252



                   Christian Brandt, Robert T
                    Wechsler, Terence J
                    O'Brien, Anna Patten,
                    Betsy Williams, Manoj
                    Malhotra, Leock Y Ngo,
                    Bernhard J Steinhoff       
       Poster Session: 2



                                               
       Time: Sunday, December 2

                                               
       12:00 p.m. to 2:00 p.m.



                                               
       Location: New Orleans, LA

                                               
       Ernest N. Morial Convention Center,

                                               
       Concourse Level in Hall B

    ---                                        ---


       
              Real-world Use

    ---

        Real-World Use and Clinical
         Characteristics of Patients
         Treated with Antiepileptic
         Drug Combinations with and
         without Perampanel in the
         United States                         
       Poster presentation number: 2.259



                   François Laliberté, Jiyoon
                    Choi, Mei Sheng Duh, Manoj
                    Malhotra, Victoria
                    Barghout, Guillaume
                    Germain, Cristi O'Connor,
                    Dominique Lejeune,  Edward
                    Faught                     
       Poster Session: 2

                                               
       Time: Sunday, December 2

                                               
       12:00 p.m. to 2:00 p.m.



                                               
       Location: New Orleans, LA

                                                   Ernest N. Morial Convention Center, on the First Floor, Hall H

    ---

        Inpatient Hospitalizations
         Rates in Patients
         Diagnosed with Epilepsy
         and Treated with
         Perampanel or Lacosamide              
       Poster presentation number: 2.152

                                               
       Poster Session: 2

                   Edward Faught, Xuan Li,
                    Jiyoon Choi, Manoj
                    Malhotra, Russell L. Knoth 
       Time: Sunday, December 2

                                               
       12:00 p.m. to 2:00 p.m.



                                               
       Location: New Orleans, LA

                                               
       Ernest N. Morial Convention Center,

                                               
       Concourse Level in Hall B

    ---

        Perampanel in real-world
         clinical care of patients
         with epilepsy:
         Retrospective Phase IV
         Study 506 - Second interim
         analysis                              
       Poster presentation number: 3.284



                   Robert T Wechsler, James
                    Wheless, Marcelo Lancman,
                    Sami Aboumatar, Anna
                    Patten, Betsy Williams,
                    Manoj Malhotra             
       Poster Session: 3



                                               
       Time: Monday, December 3

                                               
       12:00 p.m. to 2:00 p.m.



                                               
       Location: New Orleans, LA

                                                   Ernest N. Morial Convention Center, on the First Floor, Hall H

    ---


       
              Pediatric Data

    ---

        Study 311: Safety and
         efficacy of adjunctive
         perampanel (PER) in
         patients aged 4 to ?12
         years with partial-onset
         seizures (POS) with/
         without concomitant
         enzyme-inducing
         antiepileptic drugs
         (EIAEDs)                              
       Poster presentation number: 2.245



                   Mathieu Milh, Robert
                    Flamini, Andras Fogarasi,
                    Steven Phillips, Shinsaku
                    Yoshitomi, Anna Patten,
                    Takao Takase, Leock Y Ngo  
       Poster Session: 2



                                               
       Time: Sunday, December 2

                                               
       12:00 p.m. to 2:00 p.m.



                                               
       Location: New Orleans, LA

                                               
       Ernest N. Morial Convention Center,

                                               
       Concourse Level in Hall B

    ---                                        ---

        Population pharmacokinetics
         (PK) and exposure-response
         analyses of adjunctive
         perampanel (PER) in
         pediatric patients (pts)
         with epilepsy                         
       Poster presentation number: 2.246



                   Oneeb Majid, Larisa
                    Reyderman, Jim Ferry, Ziad
                    Hussein                    
       Poster Session: 2

                                               
       Time: Sunday, December 2

                                               
       12:00 p.m. to 2:00 p.m.



                                               
       Location: New Orleans, LA

                                               
       Ernest N. Morial Convention Center,

                                               
       Concourse Level in Hall B

    ---                                        ---

        Study 311: Safety and
         efficacy of adjunctive
         perampanel in younger
         (aged 4 to <7 years) and
         older (7 to <12 years)
         pediatric patients with
         partial-onset seizures
         (POS) or primary
         generalized tonic-clonic
         seizures (PGTCS)                      
       Poster presentation number : 3.287



                   Andras Fogarasi, Robert
                    Flamini, Mathieu Milh,
                    Steven Phillips, Shinsaku
                    Yoshitomi, Anna Patten,
                    Takao Takase, Leock Y Ngo  
       Poster Session: 3

                                               
       Time: Monday, December 3

                                               
       12:00 p.m. to 2:00 p.m.



                                               
       Location: New Orleans, LA

                                               
       Ernest N. Morial Convention Center,

                                               
       Concourse Level in Hall B

    ---                                        ---

        Retrospective, Phase IV
         study of perampanel in
         real-world clinical care
         of patients with epilepsy:
         Analysis of adolescent
         subgroup (aged 12 to <18
         years)                                
       Poster presentation number: 3.285



                   Eric Segal, James Wheless,
                    Katherine Moretz, Patricia
                    Penovich, Anna Patten,
                    Betsy Williams, Manoj
                    Malhotra                   
       Poster Session: 3

                                               
       Time: Monday, December 3

                                               
       12:00 p.m. to 2:00 p.m.



                                               
       Location: New Orleans, LA

                                                   Ernest N. Morial Convention Center, on the First Floor, Hall H

    ---                                        ---

        Study 506: Retrospective,
         Phase IV study of
         perampanel in real-world
         clinical care of patients
         with epilepsy: Analysis of
         a pediatric subgroup (aged
         <12 years)                            
       Poster presentation number: 3.286



                   Katherine Moretz, James
                    Wheless, Eric Segal,
                    Marcelo Lancman, Anna
                    Patten, Betsy Williams,
                    Manoj Malhotra             
       Poster Session: 3

                                               
       Time: Monday, December 3

                                               
       12:00 p.m. to 2:00 p.m.



                                               
       Location: New Orleans, LA

                                               
       Ernest N. Morial Convention Center,

                                               
       Concourse Level in Hall B

    ---                                        ---

        Study 311: Safety and
         efficacy of adjunctive
         perampanel in pediatric
         patients (aged 4 to ?12
         years) with partial-onset
         seizures (POS) or primary
         generalized tonic-clonic
         seizures (PGTCS)                      
       Poster presentation number: 3.289



                   Robert Flamini, Andras
                    Fogarasi, Mathieu Milh,
                    Steven Phillips, Shinsaku
                    Yoshitomi, Leock Y Ngo,
                    Anna Patten, Takao Takase,
                    Antonio Laurenza           
       Poster Session: 3

                                               
       Time: Monday, December 3

                                               
       12:00 p.m. to 2:00 p.m.



                                               
       Location: New Orleans, LA

                                               
       Ernest N. Morial Convention Center,

                                               
       Concourse Level in Hall B

    ---                                        ---

        Phase II, open-label
         pharmacokinetic (PK) study
         of perampanel oral
         suspension as adjunctive
         therapy in pediatric
         patients (aged >=1 to <24
         months) with epilepsy:
         Study 238 design and
         preliminary safety data               
       Poster presentation number: 3.291



                   Ben Renfroe, Guntis
                    Rozentals, Jagadeesh
                    Aluri, Yuko Umetsu, Yimin
                    Ma, Antonio Laurenza,
                    Leock Y. Ngo               
       Poster Session: 3

                                               
       Time: Monday, December 3

                                               
       12:00 p.m. to 2:00 p.m.



                                               
       Location: New Orleans, LA

                                               
       Ernest N. Morial Convention Center,

                                               
       Concourse Level in Hall B

    ---                                        ---


       
              Safety and Efficacy

    ---

        Study 410 enrollment
         update: multicenter, open-
         label, Phase IV study of
         perampanel as monotherapy
         or first adjunctive
         therapy in patients aged
         >=12 years with partial-
         onset or primary
         generalized tonic-clonic
         (PGTC) seizures                       
       Poster presentation number: 2.254



                   Pavel Klein, Betsy
                    Williams, Antonio
                    Laurenza, Anna Patten,
                    Manoj Malhotra             
       Poster Session: 2



                                               
       Time: Sunday, December 2

                                               
       12:00 p.m. to 2:00 p.m.



                                               
       Location: New Orleans, LA

                                               
       Ernest N. Morial Convention Center,

                                               
       Concourse Level in Hall B

    ---                                        ---

        Safety and Efficacy of
         Long-Term Treatment with
         Perampanel in Japanese
         Adults With Partial-Onset
         Seizures (With or Without
         Secondary Generalized
         Seizures) or Primary
         Generalized Tonic-Clonic
         Seizures in a Real-World
         Setting                               
       Poster presentation number: 1.322



                   Takuji Nishida, Yushi
                    Inoue, Kenta Sumitomo,
                    Masaru Takeuchi, Kazuhiro
                    Matsutani, Mika Ishii      
       Poster Session: 1



                                               
       Time: Saturday, December 1

                                               
       12:00 p.m. to 2:00 p.m.



                                               
       Location: New Orleans, LA

                                                   Ernest N. Morial Convention Center, on the First Floor, Hall H

    ---

        Efficacy and safety of
         adjunctive perampanel
         (PER) 4 mg/day for the
         treatment of partial-
         onset seizures (POS):
         pooled analysis of four
         randomized Phase III
         studies                               
       Poster presentation number: 2.257



                   Bernhard J Steinhoff, Anna
                    Patten, Betsy Williams,
                    Manoj Malhotra             
       Poster Session: 2



                                               
       Time: Sunday, December 2

                                               
       12:00 p.m. to 2:00 p.m.



                                               
       Location: New Orleans, LA

                                               
       Ernest N. Morial Convention Center,

                                               
       Concourse Level in Hall B



    ---                                        ---

        Perampanel (PER) inhibits
         all subtypes of AMPA
         receptors without
         affecting NMDA and kainate
         receptors                             
       Poster presentation number : 2.282



                   Kazuyuki Fukushima, Ken
                    Hatanaka, Koji Sagane, and
                    Katsutoshi Ido             
       Poster Session: 2



                                               
       Time: Sunday, December 2

                                               
       12:00 p.m. to 2:00 p.m.



                                               
       Location: New Orleans, LA

                                               
       Ernest N. Morial Convention Center,

                                               
       Concourse Level in Hall B

    ---                                        ---

        Early intervention with
         perampanel prevents
         chronic epilepsy and
         behavioral abnormalities
         in the lithium-
         pilocarpine rat model of
         status epilepticus (SE)               
       Poster presentation number: 2.231



                   Ting Wu, Yoshihide Osada,
                    Yoshiaki Furuya, Yoshimasa
                    Ito, Kazuyuki Fukushima,
                    Katsutoshi Ido             
       Poster Session: 2



                                               
       Time: Sunday, December 2

                                               
       12:00 p.m. to 2:00 p.m.



                                               
       Location: New Orleans, LA

                                               
       Ernest N. Morial Convention Center,

                                               
       Concourse Level in Hall B

    ---                                        ---


       
              Quality of Life

    ---

        Symptoms and Impacts in
         Epilepsy: Findings from
         Qualitative Patient
         Interviews                            
       Poster presentation number : 1.196



                   J French, B Williams, J
                    Choi, C Gwaltney, R Bruce,
                    J Paty, D Friedman         
       Poster Session: 1



                                               
       Time: Saturday, December 1

                                               
       12:00 p.m. to 2:00 p.m.



                                               
       Location: New Orleans, LA

                                                   Ernest N. Morial Convention Center, on the First Floor, Hall H

    ---                                        ---

This release discusses 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.

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.

INDICATION
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 treatment of primary generalized tonic-clonic (PGTC) seizures.

IMPORTANT SAFETY INFORMATION

What is FYCOMPA® (perampanel)?
FYCOMPA is a prescription medicine used:

    --  alone or with other medicines to treat partial-onset seizures with or
        without secondarily generalized seizures in people with epilepsy aged 4
        and older
    --  with other medicines to treat primary generalized tonic-clonic seizures
        in people with epilepsy aged 12 and older

Important Safety Information

What is the most important information I should know about FYCOMPA?

1. FYCOMPA may cause mental (psychiatric) problems, including:

    --  new or worse aggressive behavior (including homicidal behavior),
        hostility, anger, anxiety, or irritability
    --  being suspicious or distrustful (believing things that are not true)
    --  seeing objects or hearing things that are not there
    --  confusion
    --  difficulty with memory
    --  other unusual or extreme changes in behavior or mood

Tell your healthcare provider right away if you have any new or worsening mental problems while taking FYCOMPA.

2. Like other antiepileptic drugs, FYCOMPA may cause suicidal thoughts or actions in a very small number of people, about 1 in 500. Call your healthcare provider right away if you have any of these symptoms, especially if they are new, worse, or worry you:

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Suicidal thoughts or actions can be caused by things other than medicines. If you have suicidal thoughts or actions, your healthcare provider may check for other causes.

How can I watch for early symptoms of suicidal thoughts and actions?

    --  Pay attention to any changes especially sudden changes in mood,
        behaviors, thoughts, or feelings
    --  Keep all follow-up visits with your healthcare provider as scheduled

Call your healthcare provider between visits as needed, especially if you are worried about symptoms.

Do not stop FYCOMPA without first talking with your healthcare provider. Stopping suddenly can cause serious problems and can cause you to have seizures more often.

Before taking FYCOMPA, tell your healthcare provider about all of your medical conditions, including if you:

    --  have or have had depression, mood problems, aggressive or hostile
        behavior (for example, homicidal behavior), suicidal thoughts or
        behavior, or other psychiatric problems
    --  have liver or kidney problems
    --  drink alcohol
    --  have abused prescription medicines, street drugs, or alcohol in the past
    --  are pregnant or plan to become pregnant. It is not known if FYCOMPA will
        harm your unborn baby. If you become pregnant while taking FYCOMPA, talk
        to your healthcare provider about registering with the North American
        Antiepileptic Drug Pregnancy Registry (1-888-233-2334)
    --  are breastfeeding or plan to breastfeed. Talk to your healthcare
        provider about the best way to feed your baby if you take FYCOMPA and to
        decide if you will take FYCOMPA or breastfeed. You should not do both.

Tell your healthcare provider about all the medicines you take, including prescription and over-the-counter medicines, vitamins, and herbal supplements. Taking FYCOMPA with certain other medicines can cause side effects or reduce either drug's benefit. These medicines include: birth control, carbamazepine, phenytoin, oxcarbazepine, rifampin, and St. John's Wort.

What should I avoid while taking FYCOMPA?
Do not drive, operate heavy machinery, or do other dangerous activities until you know how FYCOMPA affects you. FYCOMPA may make you dizzy, sleepy, or tired. Do not drink alcohol or take other medicines that make you sleepy or dizzy until you talk to your healthcare provider. FYCOMPA taken with alcohol or medicines that cause sleepiness or dizziness may make your sleepiness or dizziness worse. FYCOMPA when taken with alcohol may also make your mood worse, increase anger, confusion, and depression.

What are the possible side effects of FYCOMPA?
FYCOMPA may cause other serious side effects, including:

    --  Dizziness, vertigo (sense of spinning), and problems walking normally.
        You may have problems walking normally if you are unsteady because you
        feel dizzy. These symptoms can increase when your dose of FYCOMPA is
        increased. Your risk of feeling dizzy and having problems walking
        normally may be higher if you are elderly.
    --  Sleepiness and tiredness
    --  Increased risk of falls. Taking FYCOMPA can increase your chance of
        falling. These falls can cause serious injuries. Your risk of falling
        may be higher if you are elderly.
    --  A serious allergic reaction that may affect your skin or other parts of
        your body such as your liver, kidneys, heart, or blood cells. This
        allergic reaction can be life-threatening and can cause death. Call your
        healthcare provider right away if you have:
        --  a skin rash, hives
        --  fever or swollen glands that do not go away
        --  swelling of your face
        --  shortness of breath, swelling of the legs, yellowing of the skin or
            whites of the eyes, or dark urine

The most common side effects of FYCOMPA include:


     dizziness     nausea and vomiting                           headache 
            bruising
      sleepiness           weight gain                            abdominal pain 
            anxiety
      tiredness            vertigo (sense of spinning)
      irritability       problems walking normally
      falls                    
                problems with muscle
                                      coordination

FYCOMPA is a controlled substance (CIII) because it can be abused or lead to drug dependence. Keep FYCOMPA in a safe place to protect it from theft and never give it to anyone else because it may harm them. Selling or giving away FYCOMPA is against the law.

You are encouraged to report negative side effects of prescription drugs to the FDA. Visit www.fda.gov/medwatch or call 1-800-FDA-1088

Media Inquiries
Michele Randazzo
Eisai Inc.
201-746-2979

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