Lennox–Gastaut syndrome

Longboard Pharmaceuticals Announces Positive Topline Data from a Phase 1 Clinical Study Evaluating Central Nervous System Pharmacokinetics and Pharmacodynamics of LP352 in Healthy Volunteers

Retrieved on: 
Monday, December 5, 2022
Science, Biotechnology, Research, Pharmaceutical, General Health, Health, Clinical Trials, Other Health, Longboard, Epileptic Disorders, Cmax, Security (finance), Disagreement, Chemistry, G protein-coupled receptor, Judgement, Cohort, Food, Observation, Female, Tmax, Regulation of food and dietary supplements by the U.S. Food and Drug Administration, Central nervous system, GABA, Graduate School of Asia-Pacific Studies, Plasma, Patient, Quantitative electroencephalography, GPCR, Lennox–Gastaut syndrome, LGS, Research, CDD, CSF, License, Medication, Dees, Government, Day, TID, CDKL5, COVID-19, TSC, Trial of the century, Dravet syndrome, Clinical trial, EEG, Safety, Pharmacokinetics, Marketing, AES, PD, Seizure, CNS, Male, Acquisition, Pharmaceutical industry, Palladium, Pfizer

Longboard Pharmaceuticals, Inc. (Nasdaq: LBPH), a clinical-stage biopharmaceutical company focused on developing novel, transformative medicines for neurological diseases, today announced positive topline results from a Phase 1 clinical study evaluating the central nervous system (CNS) pharmacokinetics (PK) and pharmacodynamics (PD) of LP352, an oral, centrally acting 5-HT2C superagonist, in healthy volunteers.

Key Points: 
  • Longboard Pharmaceuticals, Inc. (Nasdaq: LBPH), a clinical-stage biopharmaceutical company focused on developing novel, transformative medicines for neurological diseases, today announced positive topline results from a Phase 1 clinical study evaluating the central nervous system (CNS) pharmacokinetics (PK) and pharmacodynamics (PD) of LP352, an oral, centrally acting 5-HT2C superagonist, in healthy volunteers.
  • The primary objectives of this open-label, Phase 1 study are to assess the CNS PK and PD of orally administered LP352 in healthy adult male and female participants (n=10 in each Cohort).
  • At steady state, LP352 12 mg TID mean concentrations exceeded the Ki value for 5-HT2C activity throughout the dosing interval.
  • Longboard disclaims any intent or obligation to update these forward-looking statements, other than as may be required under applicable law.

Ovid Therapeutics to Present Data on Its Epilepsy Programs at American Epilepsy Society Annual Meeting (2022)

Retrieved on: 
Friday, December 2, 2022
Takeda Pharmaceutical Company, Lennox–Gastaut syndrome, Epilepsy, COVID-19, Safety, Vigabatrin, Seizure, Brain, Dravet syndrome, KCC2, Therapy, Benzodiazepine, CKM, MES, American Epilepsy Society, Security (finance), Annual general meeting, AES, Risk, Temporal lobe epilepsy, MB, Pharmaceutical industry, Takeda

If successful, these programs will provide hope for people with treatment-resistant epilepsies, said Jeremy Levin, D. Phil, MB BChir and Chairman and Chief Executive Officer of Ovid Therapeutics.

Key Points: 
  • If successful, these programs will provide hope for people with treatment-resistant epilepsies, said Jeremy Levin, D. Phil, MB BChir and Chairman and Chief Executive Officer of Ovid Therapeutics.
  • Our pipeline of potential medicines is designed with unique mechanisms of action to address the diverse, underlying pathophysiology of seizures.
  • Our data suggest OV329 to be a potent, next-generation GABA-AT inhibitor with the potential for seizure reduction with chronic, low dosing.
  • Data presented on OV350 support the therapeutic opportunity associated with activating KCC2, a novel target in epilepsy.

NeuroPace Feasibility Study of Its RNS System for Lennox-Gastaut Syndrome Now Underway

Retrieved on: 
Wednesday, November 30, 2022
Medical Devices, Health, Neurology, Clinical Trials, General Health, Pharmaceutical, Epilepsy, Cognition, Brain, System, Responsive neurostimulation device, Biomarker, Disability, Research, EEG, Lennox–Gastaut syndrome, Anticonvulsant, Doctor of Philosophy, National Institutes of Health, Insurance, Health, Patient, Seizure, Cerebral palsy, LGS, BRAIN Initiative, Trial of the century, Conditional sentence, FDA, Result, Growth, Financial condition report, Professor, Form 10-Q, Physician, Analysis, Autism, Annual report, Disease, IDE, Multiple sclerosis, NIH, Failure, Safety, BRAIN, MBNA, Emory Healthcare, MD, Quality of life, Pharmaceutical industry, Neurosurgery

An exciting aspect of this study is that the implant location for each patient is based on customized models of their brain connectivity.

Key Points: 
  • An exciting aspect of this study is that the implant location for each patient is based on customized models of their brain connectivity.
  • Six study sites will enroll a total of 20 patients 12 years of age and older with LGS and drug-resistant generalized onset seizures.
  • [i]
    The RNS System, a paradigm-shifting treatment for drug-resistant focal epilepsy, is the only brain-responsive neuromodulation system approved by the FDA.
  • The RNS System is available at most comprehensive epilepsy centers in the United States and is widely covered by insurance.

Lennox-Gastaut Syndrome (LGS) Research Roundtable at AES Annual Meeting Focused on Advancing Clinical Research to Find Better Treatments and Cures

Retrieved on: 
Monday, November 28, 2022
American Epilepsy Society, Patient, SAN, Round Table, AES, Conference, Multimedia, Lennox–Gastaut syndrome, Education, Research, Disease, LGS, Hope, Pharmaceutical industry, Health insurance, Manufacturing

SAN DIEGO, Nov. 28, 2022 /PRNewswire/ -- On December 2, the Lennox-Gastaut Syndrome (LGS) Foundation will host its LGS Research Roundtable at the American Epilepsy Society's (AES) annual meeting in Nashville, TN.

Key Points: 
  • SAN DIEGO, Nov. 28, 2022 /PRNewswire/ -- On December 2, the Lennox-Gastaut Syndrome (LGS) Foundation will host its LGS Research Roundtable at the American Epilepsy Society's (AES) annual meeting in Nashville, TN.
  • The event will bring together over a hundred researchers, clinicians, and family members to discuss the state of medical research in LGS.
  • The LGS Research Roundtable is an initiative of the LGS Foundation that brings together LGS patient families and research experts to discuss the barriers to better research and care and to facilitate the development and implementation of solutions.
  • Talks at the LGS Research Roundtable will set the stage for a larger LGS Meeting of the Minds Conference on the same topic that will take place in September 2023.

Cannabis Cultivation Global Market Report 2022: Ukraine-Russia War Impact

Retrieved on: 
Thursday, November 24, 2022
Aurora, Lennox–Gastaut syndrome, Electrical equipment in hazardous areas, Canopy Growth, Research report, COVID-19, Spasticity, Multiple sclerosis, Annual report, Chronic condition, Flower, Conditional sentence, CEA, GW Pharmaceuticals, Jazz Pharmaceuticals, Growth, Cannabis, Safety, Acquisition, Classification, Cannabidiol, Organization, Sale, Atlas, Drug

The cannabis cultivation market consists of sales of cannabis cultivation process by entities (organizations, sole traders, and partnerships) that is used for the production of cannabis, which is derived from the plant cannabis sativa.

Key Points: 
  • The cannabis cultivation market consists of sales of cannabis cultivation process by entities (organizations, sole traders, and partnerships) that is used for the production of cannabis, which is derived from the plant cannabis sativa.
  • Adoption of cannabis for the treatment of chronic diseases is expected to propel the growth of the cannabis cultivation market going forward.
  • Product innovations are a key trend gaining popularity in the cannabis cultivation market.Major companies operating in the cannabis cultivation market are focused on developing innovative products to strengthen their position in the cannabis cultivation market.
  • The cannabis cultivation market research report is one of a series of new reports that provides cannabis cultivation market statistics, including cannabis cultivation industry global market size, regional shares, competitors with a cannabis cultivation market share, detailed cannabis cultivation market segments, market trends and opportunities, and any further data you may need to thrive in the cannabis cultivation industry.

Ovid Therapeutics Reports Third Quarter 2022 Financial Results and Corporate Highlights

Retrieved on: 
Tuesday, November 8, 2022
GLOBE, Traffic barrier, Lennox–Gastaut syndrome, Investigational New Drug, LGS, Protein, IND, Neuroscience Research Australia, Forward-looking statement, Seizure, U.S. Securities and Exchange Commission, Partnership, Epilepsy, Research, Dravet syndrome, Risk, Technology, KCC2, COVID-19, Therapy, Nobel Prize, SEC, NASDAQ, DS, Safety, MB, PDP, Prabhu, Company, Program, Tropism, MRS, NEW, Security (finance), Central nervous system, FDA, Columbia University, Pharmaceutical industry, Cryptocurrency, Risk management, Takeda

During the third quarter, we successfully fulfilled several corporate objectives while we reduced quarter-over-quarter expenses," said Jeremy Levin, D. Phil, MB BChir, Chairman and Chief Executive Officer of Ovid.

Key Points: 
  • During the third quarter, we successfully fulfilled several corporate objectives while we reduced quarter-over-quarter expenses," said Jeremy Levin, D. Phil, MB BChir, Chairman and Chief Executive Officer of Ovid.
  • Ovid intends to initiate a Phase 1 trial in Q4 2022, following the FDA clearance of the Company's IND application for OV329.
  • Operating expenses were $12.8 million for the quarter ended September30, 2022 and $11.7 million for the same period in 2021.
  • Ovid Therapeutics Inc. is a New York-based biopharmaceutical company striving to conquer seizures and brain disorders with courageous science.

Longboard Pharmaceuticals Provides Corporate Update and Reports Third Quarter 2022 Financial Results

Retrieved on: 
Thursday, November 3, 2022
Health, Clinical Trials, Research, Pharmaceutical, Science, Biotechnology, Graduate School of Asia-Pacific Studies, G&A, Central nervous system, Private Securities Litigation Reform Act, Research, GPCR, Investment, Seizure, Longboard, Dravet syndrome, Government, Coronavirus, FDA, Lennox–Gastaut syndrome, Judgement, COVID-19, CB2, Marketing, CNS, U.S. Securities and Exchange Commission, Disagreement, Clinical trial, Medication, Dees, Acquisition, R, Security (finance), G protein-coupled receptor, SEC, CDKL5, Pharmaceutical industry, Cryptocurrency, Pfizer

Longboard Pharmaceuticals, Inc. (Nasdaq: LBPH), a clinical-stage biopharmaceutical company focused on developing novel, transformative medicines for neurological diseases, today provided a corporate update and reported financial results for the third quarter ended September 30, 2022.

Key Points: 
  • Longboard Pharmaceuticals, Inc. (Nasdaq: LBPH), a clinical-stage biopharmaceutical company focused on developing novel, transformative medicines for neurological diseases, today provided a corporate update and reported financial results for the third quarter ended September 30, 2022.
  • LP659, an oral, selective, centrally acting S1P receptor modulator, for which we have a pre-IND meeting scheduled with the FDA in the fourth quarter of 2022.
  • Third Quarter 2022 Financial Results:
    At September 30, 2022, Longboards cash, cash equivalents and short-term investments were approximately $77.3 million.
  • Longboard disclaims any intent or obligation to update these forward-looking statements, other than as may be required under applicable law.

Eisai Satisfies All-case Study Requirement for Antiepileptic Agent Inovelon

Retrieved on: 
Wednesday, November 2, 2022
MHLW, Patient, Safety, LGS, Lennox–Gastaut syndrome, Tablet, Ministry, AED, Seizure, Eisai, Pharmaceutical industry, Labour, Rufinamide, Health, Welfare

TOKYO, Nov 2, 2022 - (JCN Newswire) - Eisai Co., Ltd. announced today that it has received notification from Japan's Ministry of Health, Labour, and Welfare (MHLW) that the "all-case study" specified post-marketing observational study condition required at the time of approval of antiepileptic agent Inovelon Tablets 100 mg and 200 mg (rufinamide) as an adjunctive therapy to other antiepileptic drugs (AEDs) for treatment of Lennox-Gastaut syndrome (LGS) has been cleared.

Key Points: 
  • TOKYO, Nov 2, 2022 - (JCN Newswire) - Eisai Co., Ltd. announced today that it has received notification from Japan's Ministry of Health, Labour, and Welfare (MHLW) that the "all-case study" specified post-marketing observational study condition required at the time of approval of antiepileptic agent Inovelon Tablets 100 mg and 200 mg (rufinamide) as an adjunctive therapy to other antiepileptic drugs (AEDs) for treatment of Lennox-Gastaut syndrome (LGS) has been cleared.
  • In March 2013, the MHLW approved Inovelon as an adjunctive therapy with other antiepileptic drugs for tonic and atonic seizures associated with LGS showing insufficient response to other antiepileptics, with the following condition: "Because of the very limited number of subjects included in the Japanese clinical trials, the applicant is required to conduct a post-marketing observational study in all patients until data from a certain number of patients is accumulated after its launch in the market, in order to identify the background information of patients treated with the product and collect safety and efficacy data on the product in the early post-marketing period, and thereby take necessary measures to ensure proper use of the product."
  • Based on the safety data in 702 patients and efficacy data in 495 patients submitted to the MHLW as the results of analyses of this all-case study, the MHLW has concluded that the all-case study was conducted properly and the necessary measures to ensure proper use of the product were sufficient to lift the condition.
  • Eisai will continually strive to promote the proper use of Inovelon and provide information about the product, thereby making further contributions to increase the benefits to patients and their families.

Aquestive Therapeutics Licenses Sympazan® (clobazam) Oral Film to Assertio Holdings, Inc.

Retrieved on: 
Thursday, October 27, 2022
Company, CNS, Patent, Drug development, LinkedIn, NASDAQ, Private Securities Litigation Reform Act, Safety, Growth, Adrenaline, Anaphylaxis, Risk, Intellectual property, Lennox–Gastaut syndrome, LGS, Annual report, Patient, Technology, Diazepam, Industry, Compliance, Ageing, Legislation, GLOBE, COVID-19, LLC, Therapy, Marketing, FDA, Health, Seizure, Failure, Emergency, Allergy, Sale, Central nervous system, Pharmaceutical industry, Clobazam, Assertio Therapeutics

Sympazan (clobazam) oral film is for the adjunctive treatment of seizures associated with LennoxGastaut Syndrome (LGS) in patients aged two years of age or older.

Key Points: 
  • Sympazan (clobazam) oral film is for the adjunctive treatment of seizures associated with LennoxGastaut Syndrome (LGS) in patients aged two years of age or older.
  • Under the terms of the definitive agreement, Aquestive exclusively licensed the products intellectual property to Assertio for an upfront payment of $9.0 million.
  • Aquestive also entered into a long-term supply agreement with Assertio for Sympazan.
  • Upon the patent allowance for Sympazan, Aquestive will receive a $6.0 million milestone payment and royalties from Assertio.

Aquestive Therapeutics Announces Positive Decision in States’ Suboxone Antitrust Lawsuit on All Claims

Retrieved on: 
Monday, October 24, 2022
LinkedIn, U.S. Securities and Exchange Commission, Sale, Risk, Therapy, Growth, Buprenorphine/naloxone, Clobazam, Lennox–Gastaut syndrome, Annual report, NASDAQ, Drug development, Judgement, Court, Allergy, Seizure, Adrenaline, Technology, Private Securities Litigation Reform Act, Anaphylaxis, Company, Marketing, Industry, District court, Diazepam, Legislation, Health, Safety, CNS, GLOBE, Intellectual property, Failure, FDA, COVID-19, Central nervous system, Compliance, Pharmaceutical industry

This judgment is another step forward in improving our business, said Daniel Barber, Chief Executive Officer of Aquestive.

Key Points: 
  • This judgment is another step forward in improving our business, said Daniel Barber, Chief Executive Officer of Aquestive.
  • Aquestive Therapeutics, Inc.(NASDAQ: AQST) is a pharmaceutical company advancing current standards of care to solve patients problems through simplifying complex delivery methods.
  • We are developing orally administered products to deliver complex molecules, providing novel alternatives to invasive and inconvenient standard of care therapies.
  • PharmFilm, Sympazan and the Aquestive logo are registered trademarks ofAquestive Therapeutics, Inc.