Epilepsy syndromes

FDA Approves EPIDIOLEX® (cannabidiol) Oral Solution to Treat Seizures Associated with Tuberous Sclerosis Complex

Monday, August 3, 2020 - 12:00pm

FDA approval of this new indication is exciting news for those with refractory seizures due to tuberous sclerosis complex, said Justin Gover, GWs Chief Executive Officer.

Key Points: 
  • FDA approval of this new indication is exciting news for those with refractory seizures due to tuberous sclerosis complex, said Justin Gover, GWs Chief Executive Officer.
  • FDA approval of EPIDIOLEX in TSC is a tremendous step forward and our community applauds this positive development, said Kari Luther Rosbeck, President and CEO of the Tuberous Sclerosis Alliance.
  • In the U.S., EPIDIOLEX is indicated for the treatment of seizures associated with Lennox-Gastaut syndrome (LGS), Dravet syndrome or tuberous sclerosis complex (TSC) in patients one year of age and older.
  • EPIDIOLEX (cannabidiol) oral solution is indicated for the treatment of seizures associated with Lennox-Gastaut syndrome (LGS), Dravet syndrome (DS), or tuberous sclerosis complex (TSC) in patients 1 year of age and older.

Tuberous Sclerosis Alliance Lauds FDA Approval of Epidiolex® to Treat Seizures in People with Tuberous Sclerosis Complex

Saturday, August 1, 2020 - 2:43am

SILVER SPRING, Md., July 31, 2020 /PRNewswire/ --Today, the Tuberous Sclerosis Alliance (TS Alliance) lauds the U.S. Food and Drug Administration's (FDA's) approval of Epidiolex oral solution to treat seizures in people one year of age and older who have tuberous sclerosis complex (TSC).

Key Points: 
  • SILVER SPRING, Md., July 31, 2020 /PRNewswire/ --Today, the Tuberous Sclerosis Alliance (TS Alliance) lauds the U.S. Food and Drug Administration's (FDA's) approval of Epidiolex oral solution to treat seizures in people one year of age and older who have tuberous sclerosis complex (TSC).
  • "Up to 85 percent of those affected by TSC experience seizures at some point in their lifetime," explained TS Alliance President & CEO Kari Luther Rosbeck.
  • In 2018, the FDA approved the drug to treat people two years of age and older with Lennox-Gastaut syndrome (LGS) or Dravet syndrome.
  • Established in 1974, the Tuberous Sclerosis Alliance is an internationally recognized nonprofit organization dedicated to finding a cure for tuberous sclerosis complex while improving the lives of those affected.

Zogenix to Release Second Quarter 2020 Financial Results and Host Conference Call and Webcast on August 5

Wednesday, July 29, 2020 - 1:00pm

Zogenixis a global pharmaceutical company committed to developing and commercializing therapies with the potential to transform the lives of patients and their families living with rare diseases.

Key Points: 
  • Zogenixis a global pharmaceutical company committed to developing and commercializing therapies with the potential to transform the lives of patients and their families living with rare diseases.
  • The companys first rare disease therapy, FINTEPLA(fenfluramine) oral solution, C-IV has been approved by theU.S.FDA and is under review inEuropefor the treatment of seizures associated with Dravet syndrome, a rare, severe childhood onset epilepsy.
  • In addition, the company has two late-stage development programs underway: one for FINTEPLA for the treatment of seizures associated with Lennox-Gastaut syndrome, a rare childhood-onset epilepsy and one for MT1621, an investigational novel substrate enhancement therapy for the treatment of TK2 deficiency, a rare genetic disorder.
  • MT1621 is being developed through Modis Therapeutics, aZogenixcompany.

FDA Approves FINTEPLA® (fenfluramine) for the Treatment of Seizures Associated with Dravet Syndrome

Friday, June 26, 2020 - 1:49am

Dravet syndrome is a rare childhood-onset epilepsy marked by frequent debilitating seizures, lifelong developmental and motor impairments, and an increased risk of sudden death.

Key Points: 
  • Dravet syndrome is a rare childhood-onset epilepsy marked by frequent debilitating seizures, lifelong developmental and motor impairments, and an increased risk of sudden death.
  • About FINTEPLA (fenfluramine) oral solution, CIV
    FINTEPLA is an approved treatment, in the U.S., for seizures associated with Dravet syndrome in patients 2 years of age and older.
  • Across multiple clinical studies, FINTEPLA demonstrated significant and sustained reduction of convulsive seizures associated with Dravet syndrome.
  • If serotonin syndrome is suspected, treatment with FINTEPLA should be stopped immediately and symptomatic treatment should be started.

FDA Approves New Therapy for Dravet Syndrome

Friday, June 26, 2020 - 12:50am

Dravet syndrome is a life-threatening, rare and chronic form of epilepsy.

Key Points: 
  • Dravet syndrome is a life-threatening, rare and chronic form of epilepsy.
  • "Fintepla offers an additional effective treatment option for the treatment of seizures associated with Dravet syndrome.
  • The FDA will continue to work with companies on drug development for Dravet syndrome and other types of epilepsy."
  • The effectiveness of Fintepla for the treatment of seizures associated with Dravet syndrome was demonstrated in two clinical studies in 202subjects between ages 2 and 18.

Zogenix Introduces New Resources for Dravet Syndrome Siblings

Friday, June 12, 2020 - 1:00pm

Dravet syndrome is a rare, severe childhood-onset epilepsy marked by frequent debilitating seizures, lifelong developmental and motor impairments, and an increased risk of sudden death.

Key Points: 
  • Dravet syndrome is a rare, severe childhood-onset epilepsy marked by frequent debilitating seizures, lifelong developmental and motor impairments, and an increased risk of sudden death.
  • The severity and unpredictability of Dravet syndrome, coupled with around-the-clock concern for the family member with Dravet syndrome, can cause significant challenges for all members of the family and increase a siblings risk for anxiety and depression.
  • The VIP Sibling Kits for children ages 4-18 contain:
    The materials were presented to the U.S.-based Dravet syndrome community this week in a special Dravet Syndrome Foundation webinar and will be available through the Dravet Syndrome Foundation starting August 1, 2020.
  • Zogenix has worked with the Dravet Syndrome Foundation, the broader Dravet community, and a variety of other Dravet syndrome and mental health experts to better understand and address the impact of rare epilepsies on caregivers, families, and siblings.

KCNT1 Epilepsy Foundation, LunaPBC, and Genetic Alliance to Launch Patient-Led Discovery Program

Tuesday, May 26, 2020 - 4:00pm

SAN DIEGO and WASHINGTON, May 26, 2020 /PRNewswire/ -- The KCNT1 Epilepsy Foundation , LunaPBC , and Genetic Alliance today announced a program to assemble a patient-led drug discovery community to study disease etiology and develop therapeutic interventions for patients with KCNT1-related epilepsy.

Key Points: 
  • SAN DIEGO and WASHINGTON, May 26, 2020 /PRNewswire/ -- The KCNT1 Epilepsy Foundation , LunaPBC , and Genetic Alliance today announced a program to assemble a patient-led drug discovery community to study disease etiology and develop therapeutic interventions for patients with KCNT1-related epilepsy.
  • Fifteen years later, KCNT1 gene mutations were identified as the major disease-causing gene of this condition.
  • The program is focused on reshaping the role and experience of study participants by inviting patients and advocates as partners to help with program inception.
  • The KCNT1 Epilepsy Foundation aims to provide accurate information for parents and physicians about KCNT1 Epilepsy disease mechanisms, symptoms and treatment options.

Arvelle Therapeutics: SK Life Science, Inc. Announces US Availability of XCOPRI® (cenobamate tablets) for the Treatment of Partial (Focal) Onset Seizures in Adults with Epilepsy

Tuesday, May 12, 2020 - 8:00am

XCOPRI was recently approved by the US Food and Drug Administration (FDA) for the treatment of partial-onset seizures in adults (also known as focal-onset seizures).

Key Points: 
  • XCOPRI was recently approved by the US Food and Drug Administration (FDA) for the treatment of partial-onset seizures in adults (also known as focal-onset seizures).
  • Approximately 40% of adult patients with epilepsy have inadequate control of seizures after treatment with two antiseizure medication regimens1,2, making access to XCOPRI a significant treatment option for patients.
  • To help US based patients commence and continue their treatment program on XCOPRI, SK life science has developed an extensive new patient access program called SK life science navigator.
  • Cenobamate was discovered by SK Biopharmaceuticals and SK life science and is a new FDA-approved antiseizure medication (ASM) for the treatment of partial-onset seizures in adults (also known as focal-onset seizures).

Zogenix to Participate in the BofA Securities 2020 Virtual Healthcare Conference

Wednesday, May 6, 2020 - 1:00pm

Zogenix is a global pharmaceutical company committed to developing and commercializing therapies with the potential to transform the lives of patients and their families living with rare diseases.

Key Points: 
  • Zogenix is a global pharmaceutical company committed to developing and commercializing therapies with the potential to transform the lives of patients and their families living with rare diseases.
  • The company has two late-stage development programs underway: FINTEPLA (ZX008, fenfluramine oral solution) for the treatment of seizures associated with Dravet and Lennox-Gastaut syndromes, two rare and often-catastrophic childhood-onset epilepsies, and MT1621, a novel substrate enhancement therapy for the treatment of a rare genetic disorder called TK2 deficiency.

Zogenix to Release First Quarter 2020 Financial Results and Host Conference Call and Webcast on May 5

Tuesday, April 28, 2020 - 1:00pm

Zogenix is a global pharmaceutical company committed to developing and commercializing therapies with the potential to transform the lives of patients and their families living with rare diseases.

Key Points: 
  • Zogenix is a global pharmaceutical company committed to developing and commercializing therapies with the potential to transform the lives of patients and their families living with rare diseases.
  • The company has two late-stage development programs underway: FINTEPLA (ZX008, fenfluramine oral solution) for the treatment of seizures associated with Dravet and Lennox-Gastaut syndromes, two rare and often-catastrophic childhood-onset epilepsies, and MT1621, a novel substrate enhancement therapy for the treatment of a rare genetic disorder called TK2 deficiency.