Epileptic seizure

Marinus Pharmaceuticals to Present at SVB Leerink’s CybeRx Series: 2nd Annual CNS Forum

Retrieved on: 
Monday, June 22, 2020

Marinus Pharmaceuticals, Inc. is apharmaceutical company dedicated to the development of innovative therapeutics to treat rare seizure disorders.

Key Points: 
  • Marinus Pharmaceuticals, Inc. is apharmaceutical company dedicated to the development of innovative therapeutics to treat rare seizure disorders.
  • Ganaxolone is a positive allosteric modulator of GABAAreceptors that acts on a well-characterized target in the brain known to have anti-seizure, anti-depressant, and anti-anxiety effects.
  • Ganaxolone is being developed in IV and oral dose forms intended to maximize therapeutic reach to adult and pediatric patient populations in both acute and chronic care settings.
  • The Company intends to initiate a Phase 3 trial in status epilepticus.

Tuberous Sclerosis Alliance and Seizure Tracker™ Partner to Promote Data Sharing and Biosample Collection

Retrieved on: 
Friday, June 19, 2020

SILVER SPRING, Md., June 19, 2020 /PRNewswire/ --Today the Tuberous Sclerosis Alliance (TS Alliance) and Seizure Tracker announced a partnership to promote data sharing and biosample collection from people with tuberous sclerosis complex (TSC), a rare genetic condition that causes tumors to form in vital organs.

Key Points: 
  • SILVER SPRING, Md., June 19, 2020 /PRNewswire/ --Today the Tuberous Sclerosis Alliance (TS Alliance) and Seizure Tracker announced a partnership to promote data sharing and biosample collection from people with tuberous sclerosis complex (TSC), a rare genetic condition that causes tumors to form in vital organs.
  • The Data Share system is designed to enable website and mobile diary users to link their personally reported data to partner organizations' managed databases.
  • "Combining the TS Alliance's Natural History Database and seizure outcome data from Seizure Tracker has the potential to change the way we think about and treat seizures in people living with tuberous sclerosis complex," says Robert Moss, Co-Founder and President of Seizure Tracker.
  • Reports generated on the Seizure Tracker system provide extensive data visualizations comparing therapies against seizure activity changes while highlighting trends.

Brain Scientific Updates Disposable EEG Headset Sales Plan, Supply Scale-Up, and IP Status

Retrieved on: 
Wednesday, June 17, 2020

To address expected heightened demand for disposable medical products brought on by the COVID-19 pandemic, Brain Scientific is fast-tracking steps required for expedited commercialization of its FDA cleared NeuroCap, single-use, disposable EEG headset.

Key Points: 
  • To address expected heightened demand for disposable medical products brought on by the COVID-19 pandemic, Brain Scientific is fast-tracking steps required for expedited commercialization of its FDA cleared NeuroCap, single-use, disposable EEG headset.
  • Patent applications for Brain Scientifics disposable EEG sets are pending in the U.S. (Application No.
  • EEGs are among the most widely used tests to diagnose brain conditions, such as seizures, epilepsy, headaches, brain tumors, and sleeping problems.
  • NeuroCap is an FDA-cleared disposable EEG headset with 22 electrodes and 19 active EEG channels.

New Survey on World Hypoparathyroidism Day Highlights Need for Awareness of this Rare Endocrine Disorder and Patient Challenges to Receive Adequate Care

Retrieved on: 
Monday, June 1, 2020

The Voices of Hypopara survey revealed that the majority of patients with this rare and complex endocrine disorder still struggle to receive adequate medical care, including in the emergency room (ER) or urgent care setting.

Key Points: 
  • The Voices of Hypopara survey revealed that the majority of patients with this rare and complex endocrine disorder still struggle to receive adequate medical care, including in the emergency room (ER) or urgent care setting.
  • A calcium crash can cause an inability to speak or breathe, involuntary or painful muscle spasms and even seizures.
  • The survey also highlighted the complexity of the hypopara patient journey, including diagnosis.
  • It is an honor to be able to present the results of our survey and give voice to patients with hypopara on World Hypoparathyroidism Awareness Day.

Results of a Randomised Study Showing that Adjunctive Cenobamate Significantly Improved Seizure control in Adults with Uncontrolled Focal Seizures Published in Neurology(1)

Retrieved on: 
Thursday, May 21, 2020

The study results suggest that cenobamate may offer a potential treatment option for patients who continue to have seizures despite the use of available treatments.

Key Points: 
  • The study results suggest that cenobamate may offer a potential treatment option for patients who continue to have seizures despite the use of available treatments.
  • Coinciding with the Neurology publication, an interim report of an ongoing, open-label, phase 3 safety study of cenobamate in 1339 adults with uncontrolled focal seizures, was published in Epilepsia.
  • Randomized phase 2 study of adjunctive cenobamate in patients with uncontrolled focal seizures.
  • Cenobamate (YKP3089) as adjunctive treatment for uncontrolled focal seizures in a large, phase 3, multicenter, openlabel safety study.

InventHelp Presents a Seizure Warning Device (FLA-3242)

Retrieved on: 
Thursday, May 14, 2020

The B WAVE allows a person to better prepare for an oncoming seizure.

Key Points: 
  • The B WAVE allows a person to better prepare for an oncoming seizure.
  • It promotes peace of mind by limiting the response time it takes to render aid to a person either during the seizure, or shortly thereafter.
  • The original design was submitted to the Fort Lauderdale office of InventHelp.
  • 18-FLA-3242 InventHelp, 217 Ninth Street, Pittsburgh, PA 15222, or call (412) 288-1300 ext.

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

Retrieved on: 
Tuesday, May 12, 2020

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).

Marinus Pharmaceuticals Announces Formation of Scientific Advisory Board

Retrieved on: 
Thursday, April 30, 2020

We believe the strength and enthusiasm of our newly-formed scientific advisory board, with an expertise in clinical development and global registration strategies for novel anti-epileptic drugs, is a testament to our commitment to ganaxolone in patients with severe seizure disorders, said Scott Braunstein, M.D., Chief Executive Officer of Marinus.

Key Points: 
  • We believe the strength and enthusiasm of our newly-formed scientific advisory board, with an expertise in clinical development and global registration strategies for novel anti-epileptic drugs, is a testament to our commitment to ganaxolone in patients with severe seizure disorders, said Scott Braunstein, M.D., Chief Executive Officer of Marinus.
  • The insights from these scientific thought-leaders will be invaluable as we approach key milestones in our epilepsy programs.
  • He has served on the board of directors of the American Epilepsy Society and has been a member of advisory panels to the National Institutes of Health.
  • Marinus Pharmaceuticals, Inc. is a pharmaceutical company dedicated to the development of innovative therapeutics to treat rare seizure disorders.

Arvelle Announces European Medicines Agency Acceptance of the Marketing Authorization Application for Cenobamate

Retrieved on: 
Thursday, March 26, 2020

Zug, Switzerland, 26 March 2020 - Arvelle Therapeutics, an emerging biopharmaceutical company focused on bringing innovative treatments to patients suffering from CNS disorders, today announces that the European Medicines Agency (EMA) has accepted the marketing authorization application (MAA) for cenobamate for the adjunctive treatment of focal-onset seizures in adults with epilepsy.

Key Points: 
  • Zug, Switzerland, 26 March 2020 - Arvelle Therapeutics, an emerging biopharmaceutical company focused on bringing innovative treatments to patients suffering from CNS disorders, today announces that the European Medicines Agency (EMA) has accepted the marketing authorization application (MAA) for cenobamate for the adjunctive treatment of focal-onset seizures in adults with epilepsy.
  • Commenting on the news, Mark Altmeyer, President and CEO of Arvelle Therapeutics, said: The acceptance of the MAA marks an important milestone for Arvelle.
  • Arvelle is responsible for the development and commercialization of cenobamate, an investigational antiepileptic drug, in the European market.
  • In early 2019, SK Biopharmaceuticals entered into an exclusive licensing agreement with Arvelle Therapeutics to develop and commercialize cenobamate in Europe.

Engage Therapeutics Announces Phase 2b StATES Study of Staccato® Alprazolam for Seizure Cessation Meets Primary Endpoint

Retrieved on: 
Thursday, March 12, 2020

We are now one step closer to bringing to patients an EpiPen-like rescue treatment that works fast enough to terminate an active seizure episode.

Key Points: 
  • We are now one step closer to bringing to patients an EpiPen-like rescue treatment that works fast enough to terminate an active seizure episode.
  • We look forward to initiating a Phase 3 study in the outpatient setting later this year.
  • The multi-center StATES Study (Staccato Alprazolam Terminates Epileptic Seizures - NCT03478982 ) was designed to evaluate the safety, efficacy and usability of Staccato alprazolam in adults living with focal or generalized epilepsy who have a predictable seizure pattern in an in-patient environment.
  • In the two treatment arms of the trial, 50 of 76 total patients achieved the primary endpoint of seizure cessation with no recurrence: