Eisai Announces Presentations on Perampanel (marketed as FYCOMPA CIII) at the Annual Meeting of the American Epilepsy Society (AES)
WOODCLIFF LAKE, N.J., Nov. 22, 2017 /PRNewswire/ -- Eisai Inc. announced today the presentation of eight posters on data, including real-world use of perampanel (marketed as FYCOMPA® CIII). These data will be presented at the American Epilepsy Society (AES) Annual Meeting in Washington, D.C. from December 1-5, 2017.
"Identifying the predictors of response to treatment is invaluable, particularly in managing epilepsy," said Lynn Kramer, M.D., Chief Clinical Officer and Chief Medical Officer, Neurology Business Group, Eisai. "We are pleased to share data on this topic and hope this poster, as well as our other presentations, provide physicians with additional information that may help them expand their knowledge of perampanel and its potential role in treating epilepsy."
The following data will be presented by Eisai at this year's AES Annual Meeting:
Abstract Name Session (All Times Eastern)
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Impact of Adjunctive Perampanel on
Healthcare Resource Utilization Based on
the Number of Baseline Antiepileptic Drugs Poster: 1.301
(Clinical) Poster Session: 1
Date: Saturday, December 2
Time: 12 - 2 p.m.
--- -----------------
The Effects of Perampanel (PER) and Common-
Use Antiepileptic Drugs (AEDs) on
Secondarily Generalized Tonic-Clonic
Seizures (SGTCS) in a Rat Amygdala
Kindling Model Poster: 2.262
(Non-clinical) Poster Session: 2
Date: Sunday, December 3
Time: 12 - 2 p.m.
--- -----------------
Healthcare Resource Utilization Before and
After Perampanel as Monotherapy Based on
Claims Data Analysis Poster: 2.290
(Clinical) Poster Session: 2
Date: Sunday, December 3
Time: 12 - 2 p.m.
--- -----------------
Retrospective, Phase IV Study of Perampanel
in Real-World Clinical Care of Patients
with Epilepsy: An Interim Analysis Poster: 3.430
(Clinical) Poster Session: 3
Date: Monday, December 4
Time: 12 - 2 p.m.
--- -----------------
Assessment of the Long-Term Efficacy and
Safety of Adjunctive Perampanel in
Adolescent Patients: Post Hoc Analysis of
Open-Label Extension (OLEx) Studies Poster: 3.261
(Clinical) Poster Session: 3
Date: Monday, December 4
Time: 12 - 2 p.m.
--- -----------------
Time to Prerandomization Monthly Seizure
Count for Perampanel in Patients with
Primary Generalized Tonic-Clonic (PGTC)
Seizures: A Potential New Clinical Endpoint Poster: 3.263
(Clinical) Poster Session: 3
Date: Monday, December 4
Time: 12 - 2 p.m.
--- -----------------
Clinical Factors Associated with a Major
Response (>=75% Reduction in Seizure
Frequency per 28 Days) in Phase III Trials
of Adjunctive Perampanel in Patients (pts)
with Partial Seizures: Post Hoc
Multivariate Analysis Poster: 3.267
(Clinical) Poster Session: 3
Date: Monday, December 4
Time: 12 - 2 p.m.
--- -----------------
Extrapolation of Efficacy and Safety Data of
Adjunctive Perampanel (PER) from Phase III
Trials in Patients (Pts) with Partial
Seizures to Evaluate PER as Monotherapy Poster: 3.266
(Clinical) Poster Session: 3
Date: Monday, December 4
Time: 12 - 2 p.m.
--- -----------------
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. According to the Institute of Medicine, epilepsy is one of the most common neurological disorders, which affects about 3.4 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.
INDICATION
FYCOMPA® (perampanel) is indicated in patients with epilepsy 12 years of age and older for the treatment of partial-onset seizures (POS) with or without secondarily generalized seizures and adjunctive therapy in the treatment of primary generalized tonic-clonic (PGTC) seizures.
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
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.
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 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 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.
Please see accompanying Full Prescribing Information for FYCOMPA (perampanel), including Boxed WARNING.
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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