Status epilepticus

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.

Marinus Pharmaceuticals Announces Seven Presentations at AES 2023, New Publication in Epilepsia and Results From the Second Generation Formulation MAD Study

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Monday, November 20, 2023
Research, Finance, Neurology, FDA, Clinical Trials, Professional Services, Biotechnology, Pharmaceutical, Health, Science, Ganaxolone, American Epilepsy Society, CDKL5 deficiency disorder, Annual general meeting, Lennox–Gastaut syndrome, Efficacy, Treatment, Marinus, IND, Epilepsy, Clinical trial, Serum, Patient, Seizure, Status epilepticus, Therapy, CDD, Abstract, Kinetics, Marigold, Physician, Medication, AES, Safety, Pharmaceutical industry, Dietary supplement

Marinus will also host a scientific exhibit showcasing a series of posters highlighting the potential of ganaxolone in the treatment of refractory seizure disorders.

Key Points: 
  • Marinus will also host a scientific exhibit showcasing a series of posters highlighting the potential of ganaxolone in the treatment of refractory seizure disorders.
  • Also announced today, preliminary data from a Phase 1 MAD study of a second generation ganaxolone formulation demonstrated linear kinetics through a wide dose range that could allow individualization of treatment in patients with refractory epilepsy, a key goal for the second generation formulation.
  • The Company now anticipates initiating a clinical trial in Lennox-Gastaut syndrome with a second generation formulation in 2025.
  • While development of the second generation formulation proceeds, Marinus intends to explore new clinical programs for ZTALMY oral suspension in other refractory epilepsies in the second half of 2024.

NEURELIS ANNOUNCES PRESENTATIONS AT THE AMERICAN EPILEPSY SOCIETY ANNUAL MEETING

Retrieved on: 
Friday, December 1, 2023
Empowerment, Status epilepticus, Brain, Research, Annual general meeting, Additive effect, SAN, Food, American Epilepsy Society, Effectiveness, Panic, Literature, Plasma, Risk, Comparison, AAS, CIV, Diazepam, FDA, Prompt, Pharmacokinetics, Caregiver, Epilepsy, Human, DZP, Rat, Systematic review, AES, Pharmaceutical industry, Drug, Vaccine, Dietary supplement, Seizure, Male, Patient, Female, Safety

SAN DIEGO, Dec. 1, 2023 /PRNewswire/ -- Neurelis, Inc., today announced that the company will present six poster presentations at the American Epilepsy Society (AES) Annual Meeting held in Orlando, Florida from December 1 – 5, 2023. Two of the presentations include new analyses of data from the completed long-term phase 3 open-label, repeat-dose safety study of diazepam nasal spray (VALTOCO®) for the treatment of seizure clusters in patients with epilepsy aged ≥6 years, evaluating timing, safety, and effectiveness of treatment. A third presentation focuses on the further assessment of diazepam in a novel preclinical model dosing strategy with potential application for further in vivo studies. Additional presentations explore the concept of anticipatory anxiety of seizures (AAS) through literature review, comparison of treated and untreated seizure clusters in a retrospective analysis from the SeizureTracker® database, and the short-term impact of seizures beyond the seizure itself.

Key Points: 
  • "Our ultimate goal is to improve health outcomes by addressing gaps in seizure cluster treatment and control," said Adrian L. Rabinowicz, M.D., Chief Medical Officer.
  • "The data presented this year at the AES annual meeting demonstrate our ongoing commitment to improving the future of epilepsy care by advancing meaningful, patient-focused treatment outcomes for people with epilepsy."
  • "Neurelis is at the forefront of epilepsy research, as evidenced by the wide breadth of data presented at this year's AES annual meeting," said Enrique Carrazana, M.D., Neurelis Senior Vice President, Strategic Initiatives.
  • Results showed sustained and measurable DZP levels in plasma and brain, which were similar to levels observed in humans.

Marinus Pharmaceuticals Provides Business Update and Reports Third Quarter 2023 Financial Results

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Tuesday, November 7, 2023
Professional Services, Health, FDA, Finance, Clinical Trials, Pharmaceutical, Biotechnology, Biomedical Advanced Research and Development Authority, Research, Security (finance), NMPA, Therapy, Medication, Ganaxolone, SG, Human services, G&A, Marinus, Administration for Strategic Preparedness and Response, National Medical Products Administration, GAAP, Center for Drug Evaluation and Research, BARDA, MAD, Lennox–Gastaut syndrome, Administration, R, Development, RAISE, CDE, Epilepsy, RSE, API, TSC, NDA, U.S. Department of Defense Strategy for Operating in Cyberspace, Office of Inspector General, U.S. Department of Health and Human Services, Investment, Patient, Status epilepticus, Pharmaceutical industry, Fine chemical, Cryptocurrency, CDD

Marinus Pharmaceuticals , Inc. (Nasdaq: MRNS), a pharmaceutical company dedicated to the development of innovative therapeutics to treat seizure disorders, today reported business highlights and financial results for the third quarter ended September 30, 2023.

Key Points: 
  • Marinus Pharmaceuticals , Inc. (Nasdaq: MRNS), a pharmaceutical company dedicated to the development of innovative therapeutics to treat seizure disorders, today reported business highlights and financial results for the third quarter ended September 30, 2023.
  • Dr. Braunstein continued, “We remain acutely focused on advancing our Phase 3 clinical trials in refractory status epilepticus and tuberous sclerosis complex.
  • Net product revenue consists of ZTALMY product sales, which was launched in the U.S. in the third quarter of 2022.
  • Selected Financial Data (in thousands, except share and per share amounts)

Ovid Therapeutics Reports Third Quarter 2023 Financial Results and Corporate Updates

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Friday, November 3, 2023
Graviton, MB, KCC2, Element, Research, ROCK2, IND, TMS, Seizure, Neuron, IV, Dravet syndrome, Ligand Pharmaceuticals, SAD, Lennox–Gastaut syndrome, Development, Epilepsy, In vivo magnetic resonance spectroscopy, MRS, Transcranial magnetic stimulation, EEG, Status epilepticus, Hemangioma, Pharmaceutical industry, Takeda, Ligand

The remaining 13% interest in these potential future milestone payments and royalties was acquired by Ligand in October 2023.

Key Points: 
  • The remaining 13% interest in these potential future milestone payments and royalties was acquired by Ligand in October 2023.
  • General and administrative expenses were $6.8 million for the three months ended September 30, 2023, as compared to $7.6 million for the same period in 2022.
  • The decrease reflects the impact of headcount reductions conducted as part of organizational changes made in the first half of 2023.
  • Total operating expenses were $12.1 million for the three months ended September 30, 2023, as compared to $12.8 million for the same period last year.

NAYZILAM® (midazolam) Results Published in 'Epilepsy & Behavior' Examining the Impact of Dose on Return to Full Baseline Function (RTFBF) for People with Seizure Clusters

Retrieved on: 
Tuesday, October 31, 2023
Science, Patient, FDA, UCB, Food, Health, ScS, Hobby, Work, US Food Sovereignty Alliance, Epilepsy, Epilepsy & Behavior, Quality of life, OLE, Caregiver, Recurrence, Seizure, Syndrome, Safety, Status epilepticus, Pharmaceutical industry, Residential care

This analysis showed the estimated median time to RTFBF, regardless of treatment with one or two doses, was 90 minutes.

Key Points: 
  • This analysis showed the estimated median time to RTFBF, regardless of treatment with one or two doses, was 90 minutes.
  • Patients were followed for a median of 17 months and 7 treated seizure clusters per patient.
  • "For people living with epilepsy who unfortunately experience seizure clusters, the ability to get back to their everyday lives after these episodes is critical.
  • Another 5-mg dose could be given if the seizure did not terminate within 10 minutes or if there was seizure recurrence within 6 hours.

Ceribell Launches ClarityPro™ AI, Expanding Access to Critical Diagnosis of Electrographic Status Epilepticus

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Monday, October 30, 2023
FDA, ESE, Seizure, Medicare, Neurology, Health, NTAP, Centers for Medicare & Medicaid Services, Hospital, EEG, Patient, Status epilepticus, CMS, ICU, Medical imaging, Medical device

SUNNYVALE, Calif., Oct. 30, 2023 /PRNewswire/ -- Ceribell, Inc.® today announced the commercial release of its new AI algorithm, ClarityPro™, accompanying the availability of potential additional reimbursement for eligible Medicare patients.

Key Points: 
  • ClarityPro is an AI-based software algorithm within the Ceribell EEG system that analyzes EEG waveforms to diagnose electrographic status epilepticus (ESE).
  • It is the first acute care device to be FDA indicated for stand-alone diagnosis.
  • Ceribell is dedicated to expanding access to neurodiagnostics, which is essential to improving patient care and outcomes," said Jane Chao, Ph.D.,Ceribell's Co-founder and CEO.
  • For additional information about ClarityPro, the FDA Breakthrough Device program, the CMS NTAP program, and status epilepticus, visit https://ceribell.com/ClarityPro .

Lecanemab named one of the world's best inventions in 2023 by TIME

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Tuesday, October 24, 2023
Risk, Aneurysm, Vomiting, Cerebral edema, Focal neurologic signs, Incidence, Dementia, Nausea, Disease, Intraparenchymal hemorrhage, Intracerebral hemorrhage, CET, Chills, AI, Paracetamol, Hypersensitivity, Memory, Lecanemab, Vascular malformation, MRI, Excipient, Neuroimaging, Fatal, Thought, Dizziness, Aspirin, Edema, Anticoagulant, Cerebral amyloid angiopathy, Magnetic resonance imaging, Patient, Bronchospasm, Alzheimer's disease, Anaphylaxis, Genetic testing, TIME, ARIA, Arthralgia, Research, Eisai, Fever, Hypotension, Amyloid, Headache, Siderosis, Behavior, Invention, Observation, Hypertension, Confusion, Seizure, Angioedema, Status epilepticus, Tissue plasminogen activator, Pharmaceutical industry, Lace, Medical imaging, Copper

"It is a great honor and tremendous recognition that lecanemab is included in TIME's list of the world's best inventions this year.

Key Points: 
  • "It is a great honor and tremendous recognition that lecanemab is included in TIME's list of the world's best inventions this year.
  • TIME's annual list of the best inventions includes "200 extraordinary innovations changing lives."
  • The information was released for public disclosure, through the agency of the contact persons below, on October 24, 2023, at 4.50 p.m. CET.
  • ARIA usually occurs early in treatment and is usually asymptomatic, although serious and life-threatening events rarely can occur.

LEQEMBI® Intravenous Infusion (Lecanemab) Approved for the Treatment of Alzheimer’s Disease in Japan

Retrieved on: 
Monday, September 25, 2023
Hypersensitivity, Status epilepticus, Intracerebral hemorrhage, Cerebral amyloid angiopathy, Arthralgia, Cerebral edema, Hypotension, Aneurysm, Risk, Focal neurologic signs, Chills, Fatal, Fever, Edema, Neuroimaging, AND, Angioedema, Siderosis, Tissue plasminogen activator, Aspirin, Hypertension, Vomiting, Incidence, Excipient, ARIA, Anticoagulant, MRI, Magnetic resonance imaging, Dizziness, Amyloid, Patient, Intraparenchymal hemorrhage, Anaphylaxis, Paracetamol, Seizure, Genetic testing, Confusion, Nausea, Observation, Lecanemab, Headache, Bronchospasm, Vascular malformation, Medical device, Pharmaceutical industry, Lace, Medical imaging, Copper

INDICATION, DOSAGE AND ADMINISTRATION, AND IMPORTANT SAFETY INFORMATION IN THE U.S.

Key Points: 
  • INDICATION, DOSAGE AND ADMINISTRATION, AND IMPORTANT SAFETY INFORMATION IN THE U.S.
    LEQEMBI is indicated for the treatment of Alzheimer’s disease.
  • Treatment with LEQEMBI should be initiated in patients with mild cognitive impairment or mild dementia stage of disease, the population in which treatment was initiated in clinical trials.
  • ARIA usually occurs early in treatment and is usually asymptomatic, although serious and life-threatening events rarely can occur.
  • Testing for ApoE ε4 status should be performed prior to initiation of treatment to inform the risk of developing ARIA.

Marinus Pharmaceuticals Highlights Advancing Pipeline and Commercial Strategy at Investor and Analyst Event 

Retrieved on: 
Tuesday, September 19, 2023
Pharmaceutical, Professional Services, Health, Finance, Status epilepticus, Biomedical Advanced Research and Development Authority, Therapy, Office of Inspector General, U.S. Department of Health and Human Services, Hospital, Human services, Ganaxolone, CDKL5 deficiency disorder, Medication, Administration, Development, ATM, RAISE, Patient, Investment, Administration for Strategic Preparedness and Response, Disease, Epilepsy, Washington University School of Medicine, Webcast, Growth, BARDA, Barnes-Jewish Hospital, Pharmaceutical industry, RSE, Neurology

Marinus Pharmaceuticals , Inc. (Nasdaq: MRNS), a pharmaceutical company dedicated to the development of innovative therapeutics to treat seizure disorders, is today hosting an Investor and Analyst Event in New York to review the Company’s ongoing clinical-stage programs and commercial planning activities.

Key Points: 
  • Marinus Pharmaceuticals , Inc. (Nasdaq: MRNS), a pharmaceutical company dedicated to the development of innovative therapeutics to treat seizure disorders, is today hosting an Investor and Analyst Event in New York to review the Company’s ongoing clinical-stage programs and commercial planning activities.
  • The event begins at 9 a.m.
  • “I look forward to showcasing how we are planning to deliver on our commitment to improve the lives of more patients with refractory seizure disorders during today’s Investor and Analyst Event,” said Scott Braunstein, M.D., Chairman and Chief Executive Officer of Marinus.
  • Importantly, we have extended our cash runway into the fourth quarter of 2024 through strategic use of our existing ATM facility.