WOODCLIFF LAKE, N.J., April 25, 2014 /PRNewswire/ -- Eisai Inc. announced today that six abstracts highlighting data analyses for FYCOMPA (perampanel) will be presented at the 66th annual American Academy of Neurology (AAN) meeting, taking place in Philadelphia, PA from April 26 May 3.
"Eisai and its epilepsy franchise are committed to expanding its knowledge of current products and developing new medications for the treatment of epilepsy. The data analyses being presented at AAN add to the growing body of clinical research surrounding FYCOMPA," said Lynn Kramer, MD, President of the Neuroscience and General Medicine Product Creation Unit and Chief Clinical Officer of Eisai Company Ltd.
FYCOMPA is an adjunctive therapy for the treatment of partial-onset seizures with or without secondarily generalized seizures in patients with epilepsy age 12 and older.
The following perampanel data are being presented at this year's AAN meeting:
Effect of Adjunctive Perampanel on Cognition in Adolescents with Inadequately Controlled Partial-Onset Seizures
This Phase II study compared the short-term effect on cognition of perampanel versus placebo when administered as adjunctive therapy in adolescents with refractory partial-onset seizures. Patients ages 12 to <18 years receiving one to three antiepileptic drugs (AEDs) and experiencing uncontrolled partial-onset seizures were randomized to receive once-daily placebo or perampanel (2, 4, 8 or 12 mg/day).
Emerging Science Poster Presentation
Poster Number: P4.344;
Poster Session: 4
Analysis of Falls in Epilepsy Patients with Partial-Onset Seizures in Perampanel Phase III Trials
This post-hoc analysis assessed data from Phase III clinical trials of perampanel, examining the number of falls patients with uncontrolled partial-onset seizures experienced while randomized to receive perampanel once daily (2, 4, 8 or 12 mg doses) or placebo.
Poster Number: P3.272;
Poster Session: 3
Interim Efficacy and Safety Analysis of Adjunctive Perampanel in the Adolescent Population from the Extension Phase of 3 Double-Blind, Placebo-Controlled, Phase III (Core) Studies in Patients with Refractory Partial-Onset Seizures
This interim analysis provided additional efficacy and safety data for adjunctive perampanel in 124 adolescents ages 12-17 years with refractory partial-onset seizures who participated in the extension phase of three double-blind, randomized, placebo-controlled Phase III studies.
Poster Number: P3.271;
Poster Session: 3
Efficacy and Safety of Adjunctive Perampanel Based on Number of Antiepileptic Drugs at Baseline
This post-hoc analysis examined the efficacy and safety of perampanel based on number of concomitant antiepileptic drugs (AEDs) at baseline.
Poster Number: P3.273;
Poster Session: 3
Review of Aggression in Adults and Adolescents in Perampanel Phase III Epilepsy Clinical Trials
This post-hoc analysis examined aggression-related safety data from the pooled results of three Phase III perampanel trials. Both adult and adolescent populations were included in the analysis.
Poster Number: P3.009;
Poster Session: 3
Perampanel Clinical Studies: Analysis of Psychiatric and Behavioral Events
This analysis of psychiatric and behavioral safety data provided context and additional detail for the serious psychiatric and behavioral reactions reported in perampanel clinical trials and described in the US prescribing information.
Poster Number: P3.268;
Poster Session: 3
Important Safety Information
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
- Closely monitor patients particularly during the titration period and at higher doses
- FYCOMPA should be reduced if these symptoms occur and should be discontinued immediately if symptoms are severe or are worsening
Serious Psychiatric and Behavioral Reactions
Hostility- and aggression-related adverse reactions occurred in 12% and 20% of clinical trial patients randomized to receive FYCOMPA at doses of 8 mg and 12 mg/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. 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.
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 or 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 randomized to receive FYCOMPA at doses of 8 mg and 12 mg/day, respectively, compared to 10% of placebo-treated patients. Gait disturbance related events were reported in 12% and 16% of patients randomized to receive FYCOMPA at doses of 8 mg and 12 mg/day, respectively, compared to 2% of placebo-treated patients. These adverse reactions occurred mostly during the titration phase.
Somnolence and Fatigue
FYCOMPA caused dose-dependent increases in somnolence and fatigue-related events. Somnolence was reported in 16% and 18% of patients randomized to receive FYCOMPA at doses of 8 mg and 12 mg/day, respectively, compared to 7% of placebo patients. Fatigue-related events were reported in 12% and 15% of patients randomized to receive FYCOMPA at doses of 8 mg and 12 mg/day, respectively, compared to 5% of placebo patients. In the controlled Phase III epilepsy clinical trials, these adverse reactions occurred mostly during the titration phase. 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 were reported in 5% and 10% of patients randomized to receive FYCOMPA at doses of 8 mg and 12 mg/day, respectively, compared to 3% of placebo-treated patients.
Withdrawal of AEDs
A gradual withdrawal is generally recommended with antiepileptic drugs to minimize the potential of increased seizure frequency.
Most Common Adverse Reactions
In clinical trials, the most frequently reported dose-related adverse reactions in patients receiving FYCOMPA 8 mg or 12 mg vs placebo (4% and at least 1% higher than the placebo group) included dizziness (36% vs 9%), somnolence (16% vs 7%), fatigue (10% vs 5%), irritability (9% vs 3%), falls (7% vs 3%), nausea (7% vs 5%), ataxia (5% vs 0%), balance disorder (4% vs 1%), gait disturbance (4% vs 1%), vertigo (4% vs 1%), and weight gain (4% vs 1%).
FYCOMPA may decrease the efficacy of contraceptives containing levonorgestrel. Plasma levels of FYCOMPA were decreased when administered with carbamazepine, phenytoin and oxcarbazepine. Concomitant use with strong CYP3A inducers such as St. John's wort and rifampin should be avoided. Multiple dosing of FYCOMPA 12 mg/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 Category C and Lactation
FYCOMPA should be used during pregnancy only if the potential benefit justifies the potential risk to the fetus. 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 a nursing woman.
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 drug substance and has the potential to be abused or lead to drug dependence.
Please see the FYCOMPA (perampanel) CIII Full Prescribing Information
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, affecting 2.2 million people in the United States. About 60 percent of people with epilepsy have partial-onset seizures. In about 25 to 30 percent of patients with epilepsy, seizures cannot be controlled with treatment.
About FYCOMPA (perampanel)
FYCOMPA is an oral medication and is the first FDA-approved non-competitive AMPA (alpha-amino-3-hydroxy-5-methyl-4-isoxazolepropionic acid) glutamate receptor antagonist. Glutamate is the primary excitatory neurotransmitter in the central nervous system. The precise mechanism by which FYCOMPA exerts its antiepileptic effects in humans has not been fully elucidated.
Discovered and developed by Eisai, FYCOMPA has been approved in more than 30 countries.
FYCOMPA is supplied as 2 mg, 4 mg, 6 mg, 8 mg, 10 mg and 12 mg film-coated tablets.
Epilepsy is a therapeutic area of focus for Eisai. The company continues to make further contributions to help address the diversified needs of epilepsy patients and their families as part of its corporate human health care (hhc) mission.
At Eisai Inc., human health care is our goal. We give our first thoughts to patients and their families. As the U.S. pharmaceutical subsidiary of Tokyo-based Eisai Co., Ltd., our passionate commitment to patient care is the driving force. We are a fully integrated pharmaceutical business with discovery, clinical, manufacturing and marketing capabilities. Our key areas of commercial focus include oncology and specialty care (Alzheimer's disease, epilepsy and metabolic disorders). To learn more about Eisai Inc., please visit us at www.eisai.com/US.
Eisai Inc. has affiliates that are part of a global product creation organization that includes R&D facilities in Massachusetts, New Jersey, North Carolina and Pennsylvania, as well as a global demand chain organization that includes manufacturing facilities in Maryland and North Carolina. Eisai's global areas of R&D focus include neuroscience; oncology; metabolic disorders; vascular, inflammatory and immunological reaction; and antibody-based programs.
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