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21.11.2018 21:43:00
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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
Trevor Resnick, Anna Patten, Manoj Malhotra, Leock Y Ngo, Betsy Williams | Poster presentation number: 2.255
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
Imad M Najm, Manoj Malhotra, Anna Patten, Leock Y Ngo, Betsy Williams | Poster presentation number: 2.256
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
Christian Brandt, Robert T Wechsler, Terence J O'Brien, Anna Patten, Betsy Williams, Manoj Malhotra, Leock Y Ngo, Bernhard J Steinhoff | Poster presentation number: 2.252
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
François Laliberté, Jiyoon Choi, Mei Sheng Duh, Manoj Malhotra, Victoria Barghout, Guillaume Germain, Cristi O'Connor, Dominique Lejeune, Edward Faught | Poster presentation number: 2.259
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
Edward Faught, Xuan Li, Jiyoon Choi, Manoj Malhotra, Russell L. Knoth | Poster presentation number: 2.152 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 in real-world clinical care of patients with epilepsy: Retrospective Phase IV Study 506 – Second interim analysis
Robert T Wechsler, James Wheless, Marcelo Lancman, Sami Aboumatar, Anna Patten, Betsy Williams, Manoj Malhotra | Poster presentation number: 3.284
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)
Mathieu Milh, Robert Flamini, Andras Fogarasi, Steven Phillips, Shinsaku Yoshitomi, Anna Patten, Takao Takase, Leock Y Ngo | Poster presentation number: 2.245
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
Oneeb Majid, Larisa Reyderman, Jim Ferry, Ziad Hussein | Poster presentation number: 2.246
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)
Andras Fogarasi, Robert Flamini, Mathieu Milh, Steven Phillips, Shinsaku Yoshitomi, Anna Patten, Takao Takase, Leock Y Ngo | Poster presentation number : 3.287
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)
Eric Segal, James Wheless, Katherine Moretz, Patricia Penovich, Anna Patten, Betsy Williams, Manoj Malhotra
| Poster presentation number: 3.285
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)
Katherine Moretz, James Wheless, Eric Segal, Marcelo Lancman, Anna Patten, Betsy Williams, Manoj Malhotra | Poster presentation number: 3.286
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)
Robert Flamini, Andras Fogarasi, Mathieu Milh, Steven Phillips, Shinsaku Yoshitomi, Leock Y Ngo, Anna Patten, Takao Takase, Antonio Laurenza
| Poster presentation number: 3.289
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
Ben Renfroe, Guntis Rozentals, Jagadeesh Aluri, Yuko Umetsu, Yimin Ma, Antonio Laurenza, Leock Y. Ngo | Poster presentation number: 3.291
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
Pavel Klein, Betsy Williams, Antonio Laurenza, Anna Patten, Manoj Malhotra | Poster presentation number: 2.254
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
Takuji Nishida, Yushi Inoue, Kenta Sumitomo, Masaru Takeuchi, Kazuhiro Matsutani, Mika Ishii | Poster presentation number: 1.322
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
Bernhard J Steinhoff, Anna Patten, Betsy Williams, Manoj Malhotra | Poster presentation number: 2.257
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
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Perampanel (PER) inhibits all subtypes of AMPA receptors without affecting NMDA and kainate receptors
Kazuyuki Fukushima, Ken Hatanaka, Koji Sagane, and Katsutoshi Ido | Poster presentation number : 2.282
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)
Ting Wu, Yoshihide Osada, Yoshiaki Furuya, Yoshimasa Ito, Kazuyuki Fukushima, Katsutoshi Ido | Poster presentation number: 2.231
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
J French, B Williams, J Choi, C Gwaltney, R Bruce, J Paty, D Friedman | Poster presentation number : 1.196
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:
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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
View original content to download multimedia:http://www.prnewswire.com/news-releases/eisai-to-present-fycompa-long-term-sustained-seizure-freedom-and-pediatric-data-at-upcoming-american-epilepsy-society-annual-meeting-300754448.html
SOURCE Eisai Inc.
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