WOODCLIFF LAKE, N.J., April 24, 2019 /PRNewswire/ — Eisai Inc. today announced that one oral presentation and 20 poster presentations from its neurology portfolio will be featured at the American Academy of Neurology’s (AAN) Annual Meeting, May 4-10, in Philadelphia. The data presented will include studies in epilepsy and sleep-wake disorders. Eisai logo. (PRNewsFoto/Eisai Inc.) An oral presentation of results from three clinical studies assessing next-morning residual effects of lemborexant is scheduled at 2:06 p.m. on Thursday, May 9, during the Sleep Science and Therapy Updates session (S46). Discovered and developed by Eisai’s R&D team, lemborexant is currently being evaluated by the U.S. Food and Drug Administration (FDA) for the treatment of insomnia, a sleep-wake disorder, with a Prescription Drug User Fee Act (PDUFA) target date set for December 27, 2019.
Eisai will present seizure freedom rates as part of three posters on Study 311 – which is a study that supported the FDA approval of FYCOMPA in pediatric patients four years and older for the treatment of partial-onset seizures (POS). In addition, Eisai will present a key study examining the effects of short half-life vs long half-life antiepileptic drugs (AEDs) on the rate of inpatient hospitalizations in patients with uncontrolled epilepsy as well as data on real-world clinical care with FYCOMPA.
FYCOMPA data presentations will also include real-world analyses evaluating the use of the AED in all-cause and epilepsy-related hospitalizations in adult and adolescent patients with epilepsy; most notably, one analysis that compares FYCOMPA to lacosamide.
"The breadth of data we are presenting at AAN highlights how Eisai is breaking through with significant research to find medications for people living with highly complex, neurologic disorders," said Ivan Cheung, Chairman and CEO, Eisai Inc. "As we continue our relentless pursuit of innovation, we look forward to sharing our latest data in sleep-wake disorders and epilepsy with the scientific community at AAN and upcoming medical congresses around the world."
In addition to data presentations, AAN marks the first neurology congress at which Eisai and its partner Empatica will co-promote the Embrace2 device. Embrace2 is the first FDA-cleared, wrist-worn wearable within the field of epilepsy for detecting patterns that may be associated with convulsive seizures during periods of rest in patients ages six to adult.
Details for the presentations are as follows: 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): Final Results from the 311 Core Study J. French, B. Williams, J. Choi, C. Gwaltney, R. Bruce, J. Paty, D. Friedman Study 402 A Post-Marketing Observational Study to Evaluate the Safety and Tolerability of Perampanel as Add-On Therapy in Patients with Epilepsy Aged ≥12 Years Study 050 Pharmacokinetic (PK) Assessment of Perampanel Intravenous (IV) Formulation as a Bioequivalent Alternative to Oral Tablet Administration 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): Final Results from the 311 Core Study Examining Hospitalizations in Patients with Epilepsy and Treated with a Long versus Short Half-Life Adjunctive Antiepileptic Medication Expert Opinion: A New Treatment Algorithm for Lennox-Gastaut Syndrome (LGS) in Adult Patients Effect of Concomitant Enzyme-inducing Antiepileptic Drugs (EIAEDs) on the Safety and Efficacy of Adjunctive Perampanel in Patients Aged 4 to ˂12 Years with Partial-Onset Seizures: Final Results from the 311 Core Study 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 ELEVATE Study 410 Enrollment Update: Multicenter, Open-label, Phase IV Study of Perampanel as Monotherapy or First Adjunctive Therapy in Patients with Partial-Onset Seizures or Primary Generalized Tonic-Clonic Seizures Perampanel Use in Established, Refractory, and Super-Refractory Status Epilepticus (SE): a Summary of Cases from Austria, Finland, Germany, and Spain Study 311 and 232: Adjunctive Perampanel in Pediatric Patients with Epilepsy: Population Pharmacokinetic (PK) and Exposure-response Analyses PROVE Study 506 – Second Interim Analysis of a Retrospective, Phase IV Study of Perampanel in Real-World Clinical Care of Patients with Epilepsy: Pediatric Subgroup (Aged <12 Years) PROVE Study 506 – Second Interim Analysis of a Retrospective, Phase IV Study of Perampanel in Real-World Clinical Care of Patients with Epilepsy: Adolescent Subgroup (Aged 12 to <18 Years)
Analysis of Patient Characteristics and Outcomes by Prior AED use: Data from Pooled Observational Studies of Routine Perampanel use across Europe Portions of this release discuss investigational uses for FYCOMPA and an investigational agent, lemborexant. It is not intended to convey conclusions about efficacy or safety. There is no guarantee that any investigational uses or agents will successfully complete clinical development or gain FDA approval.
INDICATION FOR FYCOMPA
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 for primary generalized tonic-clonic (PGTC) seizures.
IMPORTANT SAFETY INFORMATION FOR 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. 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 were reported in 5% and 10% of patients in the partial-onset seizure clinical trials randomized […]
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