Epileptic seizure

Zogenix Receives Positive CHMP Opinion for FINTEPLA® (Fenfluramine) Oral Solution for the Treatment of Seizures in Patients with Dravet Syndrome

Retrieved on: 
Friday, October 16, 2020
Neurological disorders, Health, Clinical medicine, Epilepsy, RTT, Dravet syndrome, Fenfluramine, Epileptic seizure, Anticonvulsant, Phenobarbital, Epilepsy syndromes, Dravet Syndrome Foundation

Many Dravet syndrome patients continue to experience frequent severe seizures even while taking one or more currently available anti-seizure medications.

Key Points: 
  • Many Dravet syndrome patients continue to experience frequent severe seizures even while taking one or more currently available anti-seizure medications.
  • For this reason, we are excited to be another step closer to potentially introducing FINTEPLA as an important new treatment option forthese patients and their families in Europe.
  • I am thrilled that all Phase 3 studies with fenfluramine demonstrateda clinically meaningful, highly statistically significant decrease of seizure frequency in Dravet syndrome patients.
  • Earlier this year, FINTEPLA was approved by the U.S. Food & Drug Administration (FDA) for the treatment of seizures associated with Dravet syndrome in patients aged two years and older.

Eisai: Supplementary New Drug Applications for Anti-Epileptic Drug Fycompa as Monotherapy for Partial-Onset Seizures

Retrieved on: 
Friday, October 16, 2020
Neurological disorders, Health, Clinical medicine, Anticonvulsants, RTT, Epilepsy, Seizure types, Syndromes, Generalized tonic–clonic seizure, Epileptic seizure, Generalized epilepsy, Perampanel

Additionally, results of a Phase III clinical study (FREEDOM/Study 342) conducted in Japan and South Korea on untreated epilepsy patients ages 12 years to 74 years old with partial-onset seizures (with or without secondarily generalized seizures) were submitted as supplementary safety and efficacy data.

Key Points: 
  • Additionally, results of a Phase III clinical study (FREEDOM/Study 342) conducted in Japan and South Korea on untreated epilepsy patients ages 12 years to 74 years old with partial-onset seizures (with or without secondarily generalized seizures) were submitted as supplementary safety and efficacy data.
  • The submission covering partial-onset seizures in pediatric patients was based on the results of a Phase III clinical study (Study 311) of Fycompa as adjunctive therapy conducted globally on pediatric patients (ages 4 to less than 12 years) with inadequately controlled partial-onset seizures or primary generalized tonic-clonic seizures.
  • As approximately 30% of patients with epilepsy are unable to control their seizures with currently available AEDs1, this is a disease with significant unmet medical needs.
  • Fycompa has been approved in China as an adjunctive treatment for partial-onset seizures with or without secondarily generalized seizures in patients with epilepsy 12 years of age and older.

Cerevel Therapeutics Announces First Patient Dosed in Phase 2 Trial of CVL-865, an Investigational Therapy in Development for the Treatment of Epilepsy

Retrieved on: 
Tuesday, October 6, 2020
Biotechnology, General Health, Health, Science, Research, Neurological disorders, RTT, Clinical medicine, Health, Epileptic seizure, Epilepsy, GABAA receptor positive allosteric modulators, Anticonvulsants, Sodium channel blockers, Lennox–Gastaut syndrome, CVL-865, Epilepsy, Cerevel Therapeutics

The randomized, double-blind, placebo-controlled, parallel group Phase 2 study will assess the efficacy, safety and tolerability profile of CVL-865 as an adjunctive treatment in patients with drug-resistant focal onset seizures.

Key Points: 
  • The randomized, double-blind, placebo-controlled, parallel group Phase 2 study will assess the efficacy, safety and tolerability profile of CVL-865 as an adjunctive treatment in patients with drug-resistant focal onset seizures.
  • The primary outcome is a measure of the focal onset seizure frequency rate per week.
  • Approximately 65 million people worldwide suffer from epilepsy, according to the Epilepsy Foundation and the National Institute of Neurological Disorders and Stroke.
  • Headquartered in Boston, Cerevel Therapeutics is advancing its current research and development programs while exploring new modalities through internal research efforts, external collaborations or potential acquisitions.

Ovid Therapeutics Provides Soticlestat (OV935/TAK-935) Results from ARCADE and ENDYMION Studies Showing Seizure Reduction in Rare Epilepsies

Retrieved on: 
Wednesday, September 30, 2020
RTT, Endymion, Health, Clinical medicine, Epilepsy, Medicine, Epileptic seizure

Together, data from the ARCADE and ENDYMION studies show seizure frequency reduction over time.

Key Points: 
  • Together, data from the ARCADE and ENDYMION studies show seizure frequency reduction over time.
  • Data from ARCADE, while a small open-label study, and ENDYMION support previous findings of the early activity of soticlestat and, importantly, the longer-term ENDYMION study shows seizure frequency reduction across multiple rare epilepsies over time.
  • Patients with these disorders need more options to manage their treatment-resistant seizures, and collective data from the Phase 2 ELEKTRA, ARCADE and ENDYMION studies warrant further investigation of soticlestat.
  • Afterward, patients were offered the chance to continue soticlestat treatment in the ENDYMION open-label extension study, and all patients who completed ARCADE elected to roll over into ENDYMION.

Researchers at Ben-Gurion University Developed Wearable Device for Predicting Epileptic Seizures

Retrieved on: 
Tuesday, September 29, 2020
Branches of biology, Medicine, Clinical medicine, Neurophysiology, Neurotechnology, Brain–computer interfacing, Electrodiagnosis, Electrophysiology, Electroencephalography, Epileptic seizure, Epilepsy, Long-term video-EEG monitoring

BEER-SHEVA, Israel, Sept. 29, 2020 /PRNewswire/ -- Researchers at Ben-Gurion University of the Negev (BGU) developed Epiness, a new, first of its kind device for detecting and predicting epileptic seizures based on proprietary machine-learning algorithms.

Key Points: 
  • BEER-SHEVA, Israel, Sept. 29, 2020 /PRNewswire/ -- Researchers at Ben-Gurion University of the Negev (BGU) developed Epiness, a new, first of its kind device for detecting and predicting epileptic seizures based on proprietary machine-learning algorithms.
  • Up to 30% of patients do not adequately respond to anti-epileptic drugs and live under constant fear of impending seizures.
  • The device combines a wearable EEG device with state-of-the-art software that minimizes the number of necessary EEG electrodes and optimizes electrode placement on the scalp.
  • "Epileptic seizures expose epilepsy patients to various preventable hazards, including falls, burns and other injuries," said Dr. Oren Shriki.

Eisai Receives Positive Opinion from EMA's CHMP on Use of Antiepileptic Agent Fycompa in Pediatric Patients

Retrieved on: 
Wednesday, September 23, 2020
Health, Neurological disorders, Clinical medicine, RTT, Eisai, Lennox–Gastaut syndrome, Epilepsy, Epileptic seizure, Syndromes, Anticonvulsants

As we offer several treatment options in Europe, including Fycompa, Eisai pursues its mission to provide "seizure freedom" to a greater number of patients with epilepsy.

Key Points: 
  • As we offer several treatment options in Europe, including Fycompa, Eisai pursues its mission to provide "seizure freedom" to a greater number of patients with epilepsy.
  • Eisai seeks to address the diverse needs of, as well as increasing the benefits provided to, patients with epilepsy and their families.
  • Fycompa is a first-in-class anti-epileptic agent (AED) discovered and developed by Eisai.
  • Eisai is conducting a global Phase III clinical study (Study 338) for the agent in patients with seizures associated with Lennox-Gastaut syndrome.

Epilepsy Foundation Launches New Spanish-Language Content to Provide Hispanics with More Epilepsy-Related Resources

Retrieved on: 
Tuesday, September 15, 2020
Health, Medicine, Clinical medicine, Epilepsy Foundation, Epilepsy, Epileptic seizure

LANDOVER, Md., Sept. 15, 2020 /PRNewswire/ --The Epilepsy Foundation kicked off National Hispanic Heritage Month today by introducing new Spanish-language content to offer Hispanics easier-to-access medical information and resources about epilepsy and seizures.

Key Points: 
  • LANDOVER, Md., Sept. 15, 2020 /PRNewswire/ --The Epilepsy Foundation kicked off National Hispanic Heritage Month today by introducing new Spanish-language content to offer Hispanics easier-to-access medical information and resources about epilepsy and seizures.
  • The new Spanish-language content on the Epilepsy Foundation's website epilepsy.com complements the resources available to everyone impacted by epilepsy, including health education, seizure first aid trainings and toll-free 24/7 Helpline.
  • In addition to educational content, the Epilepsy Foundation recently rolled out its #StaySafeSide seizure first aid initiative in Spanish #PermanezcaSeguraDeLado .
  • "We are strengthening our commitment to the Spanish-speaking community by offering in-language content to help families better understand epilepsy," said Laura Thrall, president and chief executive officer, Epilepsy Foundation.

Bionano Genomics Expands Its Diagnostic Testing Menu with Launch of Lineagen’s EpiPanelDx PLUS Gene Panel Test that Identifies Genetic Conditions Related to Epilepsy

Retrieved on: 
Monday, September 14, 2020
Branches of biology, Biology, Health, Syndromes, Neurological disorders, Epileptic seizure, RTT, Neurodevelopmental disorder, Exome sequencing, Epilepsy, Epileptic spasms, Exome

The new laboratory developed test (LDT) and associated clinical support bolsters Lineagens diagnostic services for physicians providing care for pediatric patients with neurodevelopmental disorders (NDDs).

Key Points: 
  • The new laboratory developed test (LDT) and associated clinical support bolsters Lineagens diagnostic services for physicians providing care for pediatric patients with neurodevelopmental disorders (NDDs).
  • Lineagens current menu of FirstStepDx PLUS chromosomal microarray and NextStepDx PLUSwhole exome sequencing offers leading molecular diagnostic tests designed to help pediatricians and pediatric neurodevelopmental specialists manage their patients with NDDs.
  • Offering such physicians a test for epilepsy allows Lineagen to more comprehensively serve their needs.
  • EpiPanelDxPLUS is designed for patients who have experienced seizures, infantile spasms, encephalopathy, or febrile seizures, and has an expected 30% diagnostic yield.

Epilepsy Foundation Awards $200,000 to Support Development of Innovative Products for Epilepsy Diagnosis & Treatment

Retrieved on: 
Monday, August 31, 2020
Epilepsy, Seizure, Medicine, Epileptic seizure, Health, Clinical medicine

"The Epilepsy Foundation is committed to supporting solution-oriented innovative research," said Sonya Dumanis, PhD., Vice President, Research & Innovation.

Key Points: 
  • "The Epilepsy Foundation is committed to supporting solution-oriented innovative research," said Sonya Dumanis, PhD., Vice President, Research & Innovation.
  • Since 2012, the Epilepsy Foundation has distributed $1.2 million to 16 Epilepsy Foundation Shark Tank winners.
  • Following Epilepsy Foundation seed funding, Curadite has won additional awards for its smart pill packaging and medication adherence platform.
  • The Foundation connects people to treatment, support and resources; leads advocacy efforts; funds innovative research and the training of specialists; and educates the public about epilepsy and seizure first aid.

Cenobamate Designated Promising Innovative Medicine (PIM) by the UK’s MHRA for Treatment of Drug-Resistant Focal-Onset Seizures in Adults

Retrieved on: 
Tuesday, August 11, 2020
RTT, Clinical medicine, Organ systems, Epileptic seizure, Health, Epilepsy, Anticonvulsants, Sodium channel blockers, GABAA receptor positive allosteric modulators

Commenting on the announcement, Stuart Mulheron, General Manager UK & Ireland, Arvelle Therapeutics said: The MHRA PIM designation marks an important milestone for Arvelle.

Key Points: 
  • Commenting on the announcement, Stuart Mulheron, General Manager UK & Ireland, Arvelle Therapeutics said: The MHRA PIM designation marks an important milestone for Arvelle.
  • To date, cenobamate has been approved by the US Food and Drug Administration (FDA) for the treatment of partial-onset (focal) seizures in adults, and is commercially available in the U.S.
  • In March 2020, Arvelle announced the European Medicines Agencys (EMA) acceptance of the marketing authorization application (MAA) for cenobamate for the adjunctive treatment of focal-onset seizures in adults with epilepsy.
  • Cenobamate was discovered by SK Biopharmaceuticals and SK life science and is a new FDA-approved anti-seizure medication (ASM) for the treatment of partial-onset seizures in adults (also known as focal-onset seizures).