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New Data and Analyses on FYCOMPA and BANZEL at American Epilepsy Society Meeting Demonstrate Eisai's Continued Commitment to the Epilepsy Community
Date:11/28/2016

WOODCLIFF LAKE, N.J., Nov. 28, 2016 /PRNewswire/ -- Eisai Inc. announced today the presentation of 12 posters during the 70th annual American Epilepsy Society (AES) Annual Meeting, highlighting data from the company's anti-epileptic drugs FYCOMPA® (perampanel) CIII and BANZEL® (rufinamide). The studies investigate these two drugs across multiple age groups and types of epilepsy, offering an understanding into therapy for these difficult-to-treat conditions. In addition, data will also be shared by Eisai on the prevalence of epilepsy and the burden on caregivers of those living with epilepsy. AES 2016 will take place at the George R. Brown Convention Center in Houston, TX, from December 2-6.

"These data provide real world insights into the activity of perampanel and rufinamide in potential patients over a wide range of ages," said Lynn Kramer, M.D., Chief Clinical Officer and Chief Medical Officer, Neurology Business Group, Eisai. "Through new and continued research with perampanel and rufinamide, we aim to further educate the epilepsy community about these debilitating diseases."

This release discusses investigational uses for FDA-approved products. It is not intended to convey conclusions about efficacy or safety. There is no guarantee that any investigational uses of such products will successfully complete clinical development or gain FDA approval.

The following data will be presented during poster sessions on Sunday, December 4th through Monday, December 5th:

Poster TitlePoster Details (All Times CT)PerampanelEvaluation of Perampanel as Monotherapy for Focal Seizures: Experience from Open-Label Extension Studies

 

This post-hoc analysis evaluated the efficacy and safety of perampanel in seven patients who achieved monotherapy in the open-label extension studies for refractory focal seizures.

Poster: 2.189

Date: Sunday, December 4

Time: 12-2 PM

Location: Hall A, Level 3Adjunctive Perampanel in Patients with Partial Seizures or Primary Generalized Tonic-Clonic (PGTC) Seizures: Effect of Age at Diagnosis

 

This post-hoc analysis of perampanel Phase III studies evaluated if age at epilepsy onset impacted treatment effect for adjunctive perampanel in partial seizures and Primary Generalized Tonic-Clonic seizures.

Poster: 2.190

Date: Sunday, December 4

Time: 12-2 PM

Location: Hall A, Level 3A Systematic Review of Real World Perampanel Treatment Outcomes

 

This systematic review of 9 observational studies and 10 case reports was performed to understand how perampanel performed in the broader epilepsy population.

Poster: 2.222

Date: Sunday, December 4

Time: 12-2 PM

Location: Hall A, Level 3An Indirect Treatment Comparison (ITC) of Perampanel versus Brivaracetam in Patients with Partial-Onset Seizures (POS) With or Without Secondary Generalization

 

Using pooled data from Phase III randomized clinical trials, this ITC analysis compared the efficacy and safety of these two treatments.

Poster: 2.225

Date: Sunday, December 4

Time: 12-2 PM

Location: Hall A, Level 3Long-term efficacy and safety of adjunctive perampanel: pooled analyses of the open-label extension (OLE) studies

 

This post-hoc analyses of pooled long-term efficacy and safety outcomes in patients with generalized tonic-clonic seizures across open-label extension studies of perampanel reports on the long-term adjunctive treatment with perampanel irrespective of prior treatment.

Poster: 2.193

Date: Sunday, December 4

Time: 12-2 PM

Location: Hall A, Level 3Phase II trials of adjunctive perampanel in Japanese patients with refractory partial-onset seizures, an open-label, ascending-high-dose study (study 231) and long-term extension study (study 233)

 

These studies evaluated the safety and efficacy of perampanel in Japanese patients with refractory partial-onset seizures with or without secondarily generalized seizures.

Poster: 2.191

Date: Sunday, December 4

Time: 12-2 PM

Location: Hall A, Level 3Adjunctive Perampanel in Patients With Drug-Resistant Partial Seizures With and Without Concurrent VNS Therapy in Phase III Studies

 

This post-hoc analysis reports on the efficacy and safety of perampanel in subjects with drug-resistant partial seizures with and without concurrent vagal nerve stimulation (VNS) therapy from Phase III clinical studies.

Poster: 3.238

Date: Monday, December 5

Time: 12-2 PM

Location: Hall A, Level 3Health Care Resource Utilization Before and After Perampanel Initiation for the Treatment of Epilepsy in the United States

 

Using a large, nationally representative claims database, this analysis assessed the impact of perampanel on health care resource utilization among people with epilepsy in the U.S.

Poster: 3.255

Date: Monday, December 5

Time: 12-2 PM

Location: Hall A, Level 3RufinamideSafety and Cognitive Development Effects of Adjunctive Rufinamide in Pediatric Subjects With Inadequately Controlled Lennox-Gastaut Syndrome (LGS): Final Results From Study 303

 

These results report on the final 2-year safety, tolerability and cognitive data from Study 303, a Phase III, open-label, 2-year study of adjunctive rufinamide (oral suspension) in pediatric subjects aged =1 to <4 years with inadequately controlled Lennox-Gastaut Syndrome (LGS).

Poster: 3.363

Date: Monday, December 5

Time: 12-2 PM

Location: Hall A, Level 3

 

Eisai will also present the following posters on the burden of epilepsy on caregivers and the prevalence of epilepsy:

Poster TitlePoster Details (All Times CT)The Caregiver's Direct Medical Costs in Epilepsy

 

This health care utilization study analyzed survey responses from 500 caregivers of people with epilepsy and estimated their associated direct medical costs.

Poster: 2.338

Date: Sunday, December 4

Time: 12-2 PM

Location: Hall A, Level 3Estimating the Economic Burden of Caregiving in Epilepsy

 

This healthcare utilization study analyzed survey responses from 500 caregivers of people with epilepsy and estimated the economic impact of epilepsy for caregivers, both in terms of increased health care utilization costs and work productivity losses.

Poster: 2.335

Date: Sunday, December 4

Time: 12-2 PM

Location: Hall A, Level 3Racial Differences in the Incidence and Prevalence of Epilepsy in United States Veteran Population

 

Using the Veteran's Health Administration (VHA) Medical SAS data set, the goal of this epidemiological study was to determine the incidence and prevalence rates of epilepsy in the U.S. veteran population across various racial groups.    

Poster: 2.332

Date: Sunday, December 4

Time: 12-2 PM

Location: Hall A, Level 3

About Epilepsy
Epilepsy is a medical condition that produces seizures affecting a variety of mental and physical functions. According to the Institute of Medicine, epilepsy is one of the most common neurological disorders, which affects 2.9 million people in the United States. Partial-onset seizures are the most common type of seizure seen in people with epilepsy, accounting for 60 percent of all seizures. Generalized seizures account for approximately 40 percent of all epilepsy, with primary generalized tonic-clonic seizures being one of the most common and severe forms of generalized seizures. Lennox-Gastaut Syndrome is diagnosed in more than 30,000 children and adults in the United States.

About FYCOMPA (perampanel)
FYCOMPA (perampanel) is indicated as adjunctive therapy for the treatment of partial-onset seizures with or without secondarily generalized seizures and primary generalized tonic-clonic seizures in patients with epilepsy 12 years of age and older.

FYCOMPA is an oral medication and 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.

FYCOMPA has been designated by the U.S. Drug Enforcement Administration as a federally-controlled substance (CIII). 

Important Safety Information for FYCOMPA (perampanel) CIII WARNING: SERIOUS PSYCHIATRIC AND BEHAVIORAL REACTIONS  

• Serious or life-threatening psychiatric and behavioral adverse reactions including aggression, hostility, irritability, anger, and homicidal ideation and threats have been reported in patients taking FYCOMPA
• These reactions occurred in patients with and without prior psychiatric history, prior aggressive behavior, or concomitant use of medications associated with hostility and aggression
• Advise patients and caregivers to contact a healthcare provider immediately if any of these reactions or changes in mood, behavior, or personality that are not typical for the patient are observed while taking FYCOMPA or after discontinuing FYCOMPA

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.  The combination of alcohol and FYCOMPA significantly worsened mood and increased anger.  Homicidal ideation and/or threat have also been reported postmarketing in patients treated with FYCOMPA.  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 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 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.

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.

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 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. 

Drug Interactions
FYCOMPA may decrease the efficacy of contraceptives containing levonorgestrel. Plasma levels of FYCOMPA were decreased when administered with carbamazepine, phenytoin, or oxcarbazepine.  Concomitant use of FYCOMPA with other strong CYP3A inducers (e.g., rifampin, St. John's wort) should be avoided.  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.

Please see accompanying Full Prescribing Information for FYCOMPA (perampanel), including Boxed WARNING.

You are encouraged to report side effects of prescription drugs to the FDA. Visit www.fda.gov/medwatch or call 1-800-FDA-1088.About BANZEL (rufinamide)
BANZEL (rufinamide) is an anti-epileptic drug indicated for adjunctive treatment of seizures associated with Lennox-Gastaut syndrome (LGS) in children 1 year and older and adults. BANZEL is a triazole derivative that is structurally unrelated to currently marketed antiepileptic drugs (AEDs). The clinical significance of this structural difference has not been established. It is believed to exert its effect by regulating the activity of sodium channels in the brain which carry excessive electrical charges that may cause seizures.

BANZEL is currently available in 200 and 400 mg tablets and in a 40 mg/mL oral suspension formula for the treatment of seizures associated with Lennox-Gastaut syndrome (LGS) in children 1 year and older and adults. It has been on the market since its FDA approval on November 14, 2008.

Important Safety Information for BANZEL (rufinamide)Contraindication:

  • BANZEL is contraindicated in patients with Familial Short QT syndrome.
  • Warnings:

  • AEDs increase the risk of suicidal thoughts or behavior in patients. Patients, their caregivers, and families should be informed of the risk and advised to monitor and report any emergence or worsening of depression, suicidal thoughts or behavior, or any unusual changes in mood or behavior, or thoughts of self-harm. If these symptoms occur, consider if it may be related to the AED or illness because epilepsy itself can increase these risks.
  • Use of BANZEL has been associated with central nervous system–related adverse reactions, such as somnolence or fatigue, coordination abnormalities, dizziness, gait disturbances, and ataxia.
  • Precautions:

  • Formal cardiac ECG studies demonstrated shortening of the QT interval (mean = 20 msec, for doses = 2400 mg twice daily) with BANZEL. Caution should be used when administering BANZEL with other drugs that shorten the QT interval.
  • Multi-organ hypersensitivity syndrome has been reported in association with BANZEL therapy. In clinical trials, hypersensitivity reactions occurred in children less than 12 years of age and within 4 weeks of starting BANZEL therapy. In addition, rare cases of Drug Reaction with Eosinophilia and Systemic Symptoms and Stevens-Johnson syndrome have been reported in association with rufinamide therapy post marketing. If any of these reactions are suspected, BANZEL should be discontinued and alternative treatment started. All patients who develop a rash while taking BANZEL must be closely supervised.
  • As with all AEDs, BANZEL should be gradually withdrawn to minimize the risk of increased seizure frequency.
  • Adverse reactions:
    In the pooled, double-blind, adjunctive therapy studies in adults and pediatric patients ages 4 and older, the most commonly observed (=10%) adverse reactions with BANZEL vs placebo, respectively, were headache (25% vs 20%), dizziness (17% vs 10%), fatigue (15% vs 9%), somnolence (13% vs 9%), and nausea (11% vs 7%).

    In a multicenter, parallel group, open-label study in pediatric patients (1 year to less than 4 years of age) the most commonly observed (=10%) adverse reactions and with a higher frequency with BANZEL vs any other AED, respectively, were vomiting (24% vs 9%), somnolence (16% vs 0% ), constipation (12% vs 9%), cough (12% vs 9%), bronchitis (12% vs 0%), rash (12% vs 9%), and decreased appetite  (12% vs 9%).

    Please see the BANZEL Full Prescribing Information

    About Eisai Inc. At Eisai Inc., human health care (hhc) is our goal. We give our first thoughts to patients and their families, and helping to increase the benefits health care provides. As the U.S. pharmaceutical subsidiary of Tokyo-based Eisai Co., Ltd., we have a passionate commitment to patient care that is the driving force behind our efforts to discover and develop innovative therapies to help address unmet medical needs.

    Eisai is a fully integrated pharmaceutical business that operates in two global business groups: oncology and neurology (dementia-related diseases and neurodegenerative diseases). Each group functions as an end-to-end global business with discovery, development, and marketing capabilities. Our U.S. headquarters, commercial and clinical development organizations are located in New Jersey; our discovery labs are in Massachusetts and Pennsylvania; and our global demand chain organization resides in Maryland and North Carolina. To learn more about Eisai Inc., please visit us at www.eisai.com/US.

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