Status epilepticus

EISAI TO PRESENT DATA ON ROBUST NEUROLOGY PORTFOLIO AT THE 76th AMERICAN ACADEMY OF NEUROLOGY® (AAN) ANNUAL MEETING

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Friday, April 12, 2024
Amyloid, Angioedema, Brain, Anticoagulant, Neuroimaging, Patient, Vascular malformation, Lecanemab, Siderosis, Dementia, Cell, Seizure, ARIA, Risk, Aspirin, Focal neurologic signs, Nausea, Cerebral edema, Dizziness, Paracetamol, Arthralgia, Cerebral amyloid angiopathy, Effectiveness, Genetic testing, Intraparenchymal hemorrhage, Observation, Confusion, Alzheimer's disease, Intracerebral hemorrhage, Status epilepticus, Vomiting, Incidence, Aneurysm, Anaphylaxis, Headache, Hypersensitivity, Hypertension, MRI, Magnetic resonance imaging, Chills, Neuron, Bronchospasm, Fatal, Hypotension, Tissue plasminogen activator, Edema, Fever, Excipient, Pharmaceutical industry

Testing for ApoE ε4 status should be performed prior to initiation of treatment to inform the risk of developing ARIA.

Key Points: 
  • Testing for ApoE ε4 status should be performed prior to initiation of treatment to inform the risk of developing ARIA.
  • Depending on ARIA severity, use clinical judgment in considering whether to continue dosing, temporarily discontinue treatment, or permanently discontinue LEQEMBI.
  • There is no experience in patients who continued dosing through symptomatic ARIA-E or through asymptomatic, but radiographically severe, ARIA-E.
  • There is limited experience in patients who continued dosing through asymptomatic but radiographically mild to moderate ARIA-E.

Trevena Reports Fourth Quarter 2023 Results and Provides Corporate Update

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Monday, April 1, 2024
Blood pressure, EEG, Epilepsy, Bradycardia, Trevena, Rat, Neuropathic pain, Seizure, Central nervous system, Patient, CNS, TMS, Hospital, Sale, Chronic pain, NIH, IND, POC, Safety, Astrocyte, Status epilepticus, Neuroinflammation, Pharmaceutical industry

CHESTERBROOK, Pa., April 01, 2024 (GLOBE NEWSWIRE) -- Trevena, Inc. (Nasdaq: TRVN), a biopharmaceutical company focused on the development and commercialization of novel medicines for patients with central nervous system (CNS) disorders, today reported its financial results for the fourth quarter ended December 31, 2023 and provided an overview of its recent operational highlights.

Key Points: 
  • Given performance to date, we are reducing commercial support and reviewing alternatives for OLINVYK to preserve capital,” said Carrie Bourdow, President and CEO of Trevena.
  • OLINVYK will remain available for purchase by customers, who can continue to order the product through their normal channels.
  • In a review of safety and tolerability across both studies, TRV045 was well tolerated with results generally consistent with prior first-in-human studies.
  • For the fourth quarter of 2023, the Company reported a net loss attributable to common stockholders of $16.5 million, or $1.06 per share, compared to $7.0 million, or $0.73 per share in the fourth quarter of 2022.

Ligand Pharmaceuticals Announces New Topiramate Injection Data Presented at 9th London-Innsbruck Colloquium on Status Epilepticus and Acute Seizures Conference

Retrieved on: 
Monday, April 8, 2024
Health, Neurology, Clinical Trials, Research, Science, Pharmaceutical, Biotechnology, Epilepsy, Plasma, LGND, Conference, UMN, Seizure, Status epilepticus, Patient, Topiramate, Orphan, Pharming, Concomitant, Pharmacokinetics, University, Faculty, Safety, Poster, Food, Pharmaceutical industry

The poster was featured at the 9th London-Innsbruck Colloquium on Status Epilepticus and Acute Seizures Conference in London, England.

Key Points: 
  • The poster was featured at the 9th London-Innsbruck Colloquium on Status Epilepticus and Acute Seizures Conference in London, England.
  • The authors presented modeling and simulations of IV topiramate dosing based on previous studies conducted by UMN faculty in healthy research participants and patients.
  • Ligand licensed the rights to the IV formulation of topiramate from UMN and entered into a global license agreement with CURx Pharmaceuticals to further develop and commercialize the product.
  • “The availability of an injectable topiramate formulation will make it possible to ensure continuity of therapy.

Marinus Pharmaceuticals Comments on Patent Challenge by Ovid Therapeutics Inc. and Provides Update on Marinus’ Post Grant Review

Retrieved on: 
Wednesday, March 27, 2024
Professional Services, Health, Neurology, Legal, Finance, General Health, Pharmaceutical, PGR, Plasma, Medication, Patent, Patient, Ganaxolone, PTAB, IPR, Marinus, Pharmacology, Inter partes review, Patent office, Therapy, Epilepsy, Status epilepticus, Pharmaceutical industry

This challenge relates to a Marinus patent for the use of ganaxolone in treating status epilepticus (SE) and refractory status epilepticus (RSE).

Key Points: 
  • This challenge relates to a Marinus patent for the use of ganaxolone in treating status epilepticus (SE) and refractory status epilepticus (RSE).
  • “Over the past two decades, Marinus has invested more than $100 million into our ganaxolone development programs in SE,” stated Dr. Scott Braunstein, Chairman and CEO of Marinus.
  • We believe this Ovid challenge is without merit and is an unfortunate distraction to the important work we do at Marinus.
  • In response to Marinus’ request for PGR, Ovid abandoned 23 of the 31 claims in its patent.

Enhancing National Preparedness: Rafa Laboratories Partners with BARDA to Advance the Development of a new design for Rafa's Pediatric Atropine Autoinjectors

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Wednesday, March 20, 2024
Development, Poisoning, Organophosphate, VX, Status epilepticus, Patient, Nerve agent, Clothing, Laboratory, Human services, Atropine, Sarin, Administration, FDA

Atropine - the primary antidote for nerve agent and insecticide poisoning, is usually administered via autoinjectors.

Key Points: 
  • Atropine - the primary antidote for nerve agent and insecticide poisoning, is usually administered via autoinjectors.
  • Rafa Laboratories already manufactures adult atropine autoinjectors, FDA-approved in July 2018, and pediatric atropine autoinjectors authorized for use under FDA Emergency Use Authorization (EUA) in January 2018.
  • The new design for the pediatric atropine autoinjector, which is intended for civilian use, will incorporate a new needle shield mechanism feature.
  • To meet FDA approval requirements for the enhanced pediatric atropine autoinjector, BARDA will provide comprehensive support to Rafa Laboratories.

Enhancing National Preparedness: Rafa Laboratories Partners with BARDA to Advance the Development of a new design for Rafa's Pediatric Atropine Autoinjectors

Retrieved on: 
Wednesday, March 20, 2024
Development, Poisoning, Organophosphate, VX, Status epilepticus, Patient, Nerve agent, Clothing, Laboratory, Human services, Atropine, Sarin, Administration, FDA

Atropine - the primary antidote for nerve agent and insecticide poisoning, is usually administered via autoinjectors.

Key Points: 
  • Atropine - the primary antidote for nerve agent and insecticide poisoning, is usually administered via autoinjectors.
  • Rafa Laboratories already manufactures adult atropine autoinjectors, FDA-approved in July 2018, and pediatric atropine autoinjectors authorized for use under FDA Emergency Use Authorization (EUA) in January 2018.
  • The new design for the pediatric atropine autoinjector, which is intended for civilian use, will incorporate a new needle shield mechanism feature.
  • To meet FDA approval requirements for the enhanced pediatric atropine autoinjector, BARDA will provide comprehensive support to Rafa Laboratories.

Ovid Therapeutics Reports Business Updates, Fourth Quarter and Full Year 2023 Financial Results

Retrieved on: 
Friday, March 8, 2024
Graviton, Epilepsy, Pharmacy technician, CCM, Research, Transcranial magnetic stimulation, DS, Neuron, Vigabatrin, LGS, Psychosis, Biomarker, Element, Ligand Pharmaceuticals, Lennox–Gastaut syndrome, Patient, Acceleration, Medicine, Status epilepticus, Dravet syndrome, ROCK2, KCC2, Hemangioma, IND, Seizure, Pharmaceutical industry

In addition, Takeda is expected to read out results from two pivotal Phase 3 studies evaluating soticlestat.

Key Points: 
  • In addition, Takeda is expected to read out results from two pivotal Phase 3 studies evaluating soticlestat.
  • Of these potential future payments, Ovid sold a 13% interest to Ligand Pharmaceuticals for $30 million in October 2023.
  • Financial runway: Ovid anticipates its cash runway will support operations and clinical development programs into the first half of 2026.
  • Ovid also anticipates several events for its current pipeline programs and clinical results for soticlestat from Takeda in 2024.

Crossject provides strategic update on priorities for 2024

Retrieved on: 
Tuesday, February 6, 2024
Administration, Government, Food and Drug Administration, Parseval, HHS, FDA, USG, BNP, Status epilepticus, Syneos Health, Food, ASPR, Seizure, BPI, EUR, Caisse, Groupe Caisse d'Épargne, Development, Emergency, Pharmaceutical industry

Focusing on regulatory filings and accelerating U.S. commercialization efforts

Key Points: 
  • Focusing on regulatory filings and accelerating U.S. commercialization efforts
    Contract of up to $155 million with BARDA for U.S. stockpiling continues to advance
    Dijon, France February 6, 2024 –530 pm CET Crossject (ISIN: FR0011716265; Euronext: ALCJ), a specialty pharma company developing needle-free auto-injectors for emergency situations, provides a summary of recent milestones reached and an update on its strategic priorities for 2024.
  • Syneos Health has a strong U.S. presence and significant expertise in commercializing new therapies for Crossject, as it approaches filing for regulatory approval.
  • In 2024, Crossject will especially focus on regulatory approvals for ZEPIZURE® and accelerating market access efforts in the United States.
  • We are working closely with our strategic partners market access activities in the US,” said Patrick Alexandre, CEO of Crossject.

Physicians Describe "Underrecognized Neurological Emergency" in New Clinical Proceedings Paper

Retrieved on: 
Thursday, January 18, 2024
Risk, Ferhat Ozcep, Seizure, Convulsion, Mortality, Disease, Status epilepticus, Diagnosis, EEG, Medical device

WASHINGTON, Jan. 18, 2024 /PRNewswire/ -- A lack of convulsions can make some extended seizures difficult to diagnose and treat, explains a new expert-led clinical proceedings paper from the Clinical Neurological Society of America. "Nonconvulsive Status Epilepticus: An Underrecognized Neurological Emergency" notes that, while convulsions are a clear sign of status epilepticus, not all seizures are accompanied by them.

Key Points: 
  • Not all seizures include convulsions, neurologists explain, leading to diagnosis challenges and dangerous treatment delays
    WASHINGTON, Jan. 18, 2024 /PRNewswire/ -- A lack of convulsions can make some extended seizures difficult to diagnose and treat, explains a new expert-led clinical proceedings paper from the Clinical Neurological Society of America. "
  • Nonconvulsive Status Epilepticus: An Underrecognized Neurological Emergency " notes that, while convulsions are a clear sign of status epilepticus, not all seizures are accompanied by them.
  • That's why EEGs – continuous if available, or at least rapid EEG for emergency monitoring – are essential to properly diagnose NCSE, the paper explains.
  • better identification of nonconvulsive status epilepticus, or NCSE
    the use of electroencephalograms or EEGs for diagnosis, and
    timely treatment to stop seizures.

Neurona Therapeutics Presents New Clinical Data from First Cohort in Ongoing Phase I/II Open-Label Trial of NRTX-1001 Cell Therapy for Drug-resistant Mesial Temporal Lobe Epilepsy (MTLE)

Retrieved on: 
Friday, December 1, 2023
Phase, Immunosuppression, DSMB, DSM-IV codes, Data monitoring committee, FDA, American Epilepsy Society, SAN, Therapy, Clinical trial, Seizure, Generalized tonic–clonic seizure, Annual general meeting, Patient, History, Status epilepticus, Pharmaceutical industry

SAN FRANCISCO, Dec. 01, 2023 (GLOBE NEWSWIRE) -- Neurona Therapeutics, a clinical-stage biotherapeutics company advancing regenerative cell therapy candidates for the treatment of neurological disorders, announced presentation of positive preliminary clinical data from the first cohort of five subjects in its ongoing open-label, single-arm Phase I/II clinical trial of NRTX-1001, an investigational allogeneic cell therapy candidate that is being developed for treatment of drug-resistant MTLE. The data will be presented at the Annual Meeting of the American Epilepsy Society, which is being held December 1-5, 2023 in Orlando, Florida.

Key Points: 
  • The data will be presented at the Annual Meeting of the American Epilepsy Society, which is being held December 1-5, 2023 in Orlando, Florida.
  • “The early data from the first cohort in the trial have been very encouraging, with substantial, durable seizure reduction in the first subjects with drug-resistant MTLE.
  • All subjects who received NRTX-1001 in the ongoing clinical trial entered the study with a history of significant monthly seizure activity that was not controlled by anti-seizure medications.
  • No severe adverse events from the cell therapy, delivery procedure, or immunosuppression regimen have been reported thus far in the ongoing clinical trial.