Benzodiazepine

ICH M14 guideline on general principles on plan, design and analysis of pharmacoepidemiological studies that utilize real-world data for safety assessment of medicines Step 2b

Retrieved on: 
星期日, 六月 2, 2024
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    Millennium Health Signals Alert™ Shows Pandemic-Era Increases in Alcohol Use Persist Among At-Risk Patients

    Retrieved on: 
    星期二, 五月 21, 2024

    Alcohol use increased across the U.S. during the COVID-19 pandemic but a new Millennium Health Signals Alert™ shows that it increased most dramatically among those with alcohol use disorder (AUD) and has remained elevated; up more than 20% nationally since 2019.

    Key Points: 
    • Alcohol use increased across the U.S. during the COVID-19 pandemic but a new Millennium Health Signals Alert™ shows that it increased most dramatically among those with alcohol use disorder (AUD) and has remained elevated; up more than 20% nationally since 2019.
    • View the full release here: https://www.businesswire.com/news/home/20240520017267/en/
      “These findings are eye opening and reveal that the pandemic had a lasting negative impact on this at-risk group of patients.
    • We’re calling attention to this problem now because our data also show that alcohol use tends to increase in the summer,” said Millennium Health Chief Clinical Officer Angela Huskey, PharmD, CPE.
    • Included specimens were from patients aged 18 years or older and collected in health care practices located in all 50 states.

    Incannex Healthcare Inc. Quarterly Update, Q1 2024

    Retrieved on: 
    星期二, 四月 16, 2024

    MELBOURNE, Australia, April 16, 2024 (GLOBE NEWSWIRE) -- Clinical stage pharmaceutical development company, Incannex Healthcare Inc. (NASDAQ: IXHL), (‘Incannex’ or the ‘Company’), is pleased to provide quarterly activities update and for the quarter ended 31 March 2024.

    Key Points: 
    • MELBOURNE, Australia, April 16, 2024 (GLOBE NEWSWIRE) -- Clinical stage pharmaceutical development company, Incannex Healthcare Inc. (NASDAQ: IXHL), (‘Incannex’ or the ‘Company’), is pleased to provide quarterly activities update and for the quarter ended 31 March 2024.
    • Incannex is undertaking various U.S. Food and Drug Administration (‘FDA’) research and development (‘R&D’) programs for cannabinoid pharmaceutical products and psychedelic medicine therapies.
    • During the quarter, Incannex released top line results from the PsiGAD1 clinical trial conducted at Monash University, based in Melbourne, Australia.
    • This announcement has been approved for release to NASDAQ by the Incannex Board of Directors.

    Joint Statement from the Co-Chairs of the Special Advisory Committee on the Epidemic of Opioid Overdoses - Latest National Data on Substance-Related Harms

    Retrieved on: 
    星期三, 三月 27, 2024

    These numbers are the largest observed since data collection  began in 2016, signifying the ongoing worsening of this urgent public health crisis.

    Key Points: 
    • These numbers are the largest observed since data collection  began in 2016, signifying the ongoing worsening of this urgent public health crisis.
    • These latest data show that in Canada between January and September 2023, there were 5,975 apparent opioid-related deaths and 4,646 hospitalizations for opioid-related poisonings.
    • New data from emergency departments (ED) show that during the same period, there were 21,708 reported opioid poisoning ED visits, which is 80 per day.
    • While it may take time to see results, everything we do to help combat this crisis and save lives is critical.

    Gabather reports initial positive results from the EEG/fMRI target engagement study

    Retrieved on: 
    星期四, 三月 7, 2024

    STOCKHOLM, March 7, 2024 /PRNewswire/ -- Gabather AB (Nasdaq First North Growth Market: GABA) today reports initial positive results from the EEG/fMRI target engagement study, a double-blinded placebo-controlled, cross-over phase Ib study of Gabather's GABAA-receptor positive allosteric modulator, GT-002, in healthy volunteers.

    Key Points: 
    • STOCKHOLM, March 7, 2024 /PRNewswire/ -- Gabather AB (Nasdaq First North Growth Market: GABA) today reports initial positive results from the EEG/fMRI target engagement study, a double-blinded placebo-controlled, cross-over phase Ib study of Gabather's GABAA-receptor positive allosteric modulator, GT-002, in healthy volunteers.
    • The study met the primary objective to confirm a favourable safety and tolerability profile of GT-002.
    • The secondary objective to demonstrate target engagement in human brain was also met.
    • The study clearly demonstrated that GT-002 is safe and well tolerated at dose levels expected to be effective for treatment of patients with neuropsychiatric disorders.

    Gabather reports initial positive results from the EEG/fMRI target engagement study

    Retrieved on: 
    星期四, 三月 7, 2024

    STOCKHOLM, March 7, 2024 /PRNewswire/ -- Gabather AB (Nasdaq First North Growth Market: GABA) today reports initial positive results from the EEG/fMRI target engagement study, a double-blinded placebo-controlled, cross-over phase Ib study of Gabather's GABAA-receptor positive allosteric modulator, GT-002, in healthy volunteers.

    Key Points: 
    • STOCKHOLM, March 7, 2024 /PRNewswire/ -- Gabather AB (Nasdaq First North Growth Market: GABA) today reports initial positive results from the EEG/fMRI target engagement study, a double-blinded placebo-controlled, cross-over phase Ib study of Gabather's GABAA-receptor positive allosteric modulator, GT-002, in healthy volunteers.
    • The study met the primary objective to confirm a favourable safety and tolerability profile of GT-002.
    • The secondary objective to demonstrate target engagement in human brain was also met.
    • The study clearly demonstrated that GT-002 is safe and well tolerated at dose levels expected to be effective for treatment of patients with neuropsychiatric disorders.

    Using ‘trip killers’ to cut short bad drug trips is potentially dangerous

    Retrieved on: 
    星期三, 二月 14, 2024

    As interest in psychedelics has grown, so has interest in ways to end a bad trip.

    Key Points: 
    • As interest in psychedelics has grown, so has interest in ways to end a bad trip.
    • Recent research reveals that people are giving potentially dangerous advice on social media on how to stop a trip that is less than pleasurable.
    • One of the earliest descriptions of a psychedelic experience in western literature can be found in Aldous Huxley’s 1953 book The Doors of Perception.
    • Research shows that if someone is in a bad mood or depressed then they are more likely to have a bad trip, as are people who take too high a dose.

    Trip killers

    • Few clinical studies have examined trip killers, but one has found that ketanserin – a drug used to treat high blood pressure – reverses the psychedelic effects of LSD.
    • A recent article in the Emergency Medical Journal analysed posts on Reddit about trip killers.
    • Trip killers were discussed most often for LSD (235 posts), magic mushrooms (143 posts) and MDMA (21 posts).

    Receptor blocking

    • To kill a trip then, one simply has to give the drug user another drug that blocks (rather than activates) the 5-HT2A receptor.
    • Many prescription drugs can do this and they tend to be antipsychotic drugs.
    • Quetiapine from the list above is one popular example, while another antipsychotic, olanzapine, was mentioned in 14 posts in that study.
    • Similarly, the atypical antidepressants trazodone and mirtazapine also block the 5-HT2A receptor.


    Colin Davidson has previously received funding from the National Institute on Drug Abuse (NIH, USA) and the European Community for projects related to stimulant drug abuse and novel psychoactive compounds respectively. He is currently a paid consultant with the Defence Science Technology Laboratory (MOD) working on new psychoactive compounds.

    Reflection paper on investigation of pharmacokinetics in the obese population - Scientific guideline

    Retrieved on: 
    星期三, 二月 14, 2024

    Reflection paper on investigations of pharmacokinetics in

    Key Points: 
      • Reflection paper on investigations of pharmacokinetics in
        the obese population
        Table of contents
        1.
      • References .............................................................................................. 9

        Reflection paper on investigations of pharmacokinetics in the obese population
        EMA/CHMP/535116/2016

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        1.

      • This is considered
        a shortcoming that is potentially compounded by obese patients often being poorly represented in
        clinical studies.
      • The specific aims of this reflection paper are to:
        ?

        describe how the effects of obesity can be investigated during clinical medicinal product
        development.

      • ?

        provide recommendations on when investigations of the effect of obesity on the PK of a
        medicinal product should be particularly considered.

      • Reflection paper on investigations of pharmacokinetics in the obese population
        EMA/CHMP/535116/2016

        Page 3/12

        ?

        discuss how to reflect PK (and/or PK/PD) findings in weight/weight-based dosing
        recommendations.

      • Absorption
        Reduced rate of absorption linked to locally reduced blood flow (8) is reported for the subcutaneous
        and transdermal routes in obese subjects.
      • Distribution
        The distribution of medicinal products is driven by body composition, regional blood flow and binding to
        tissue and plasma proteins.
      • Obese subjects have a larger absolute lean body weight (LBW) as well as fat mass.
      • The physicochemical properties of a medicinal product (lipophilicity, polarity, molecular size, and
        degree of ionization) influence its distribution in the body.
      • In BMI class III obese
        subjects, the blood flow per gram of fat is significantly lower than that observed in class I obese or
        lean subjects (4).
      • Reflection paper on investigations of pharmacokinetics in the obese population
        EMA/CHMP/535116/2016

        Page 4/12

        An increased amount of alpha-1-acid-glycoprotein (AAG), linked to a chronic inflammatory state, is
        reported in obese individuals.

      • Fatty infiltrations are present in the liver for 90% of obese subjects, with the extent of the infiltrations
        being proportional to the degree of obesity.
      • In some cases, in particular for CYP3A4 metabolized medicinal products,
        bodyweight normalized clearance can be lower in obese patients (23).
      • Based on presently available data, it has been suggested that uptake transporters

        Reflection paper on investigations of pharmacokinetics in the obese population
        EMA/CHMP/535116/2016

        Page 5/12

        are downregulated while efflux transporters may be upregulated (31).

      • Platelet hyper-reactivity is also observed,
        which can impair the response to anti-platelet medicinal products in obese patients (42, 43).
      • Reflection paper on investigations of pharmacokinetics in the obese population
        EMA/CHMP/535116/2016

        Page 6/12

        3.

        the medicinal product properties and scientific literature indicate that obesity may lead to a
        marked effect on elimination and/or distribution or on the PK/PD relationship.

      • These
        models may aid in extrapolating the known efficacy and safety in the non-obese population to the
        obese population.
      • The Pharmacokinetics of the CYP3A Substrate Midazolam in Morbidly Obese Patients
        Before and One Year After Bariatric Surgery.
      • Reflection paper on investigations of pharmacokinetics in the obese population
        EMA/CHMP/535116/2016

        Page 11/12

        41.

      • Reflection paper on investigations of pharmacokinetics in the obese population
        EMA/CHMP/535116/2016

        Page 12/12

    Recognizing when someone is having a seizure – and how you can help during those first critical moments

    Retrieved on: 
    星期三, 二月 14, 2024

    But experiencing a seizure does not always mean a person has epilepsy.

    Key Points: 
    • But experiencing a seizure does not always mean a person has epilepsy.
    • Seizures can be provoked by acute head injuries, alcohol withdrawal and high blood sugar, among other things.

    What does a seizure look like?

    • For some people, their seizure is a purely internal sensation.
    • In fact, most people with epilepsy have only relatively subtle, nonconvulsive seizures at first, then develop convulsive seizures over time.
    • This is the type of seizure most of us are familiar with, probably because it’s the kind most frequently depicted, though not always accurately, in movies and on television.
    • The most common type of epileptic seizure are those that are focal – that is, they arise from a confined region of the brain.

    What causes a seizure to occur?


    Seizures are the result of abnormal electrical activity in the brain. The bursts of activity disrupt normal functioning and initiate hyperactivity in the affected brain area, which then can affect the corresponding body part. For instance, if the seizure arises from the part of the brain involved in arm movement, that arm will experience involuntary hyperactivity.

    If you’re a bystander, how can you help?

    • Many seizure-related injuries occur due to falling or coming in contact with sharp or hard objects.
    • If they begin to fall, help them to the floor as gently as possible and put something soft under their head.
    • During the convulsive phase of a seizure, breathing may be intermittent.
    • So turn the person on their side so they can breathe more easily and lower the risk of aspiration.
    • Following the seizure, and as the person gradually recovers and wakes up, help them sit up in a safe space.

    Are new treatments available?

    • People with epilepsy, particularly those who experience frequent seizures, will often have emergency medications in their possession.
    • The most common emergency medications – also called seizure rescue medications – are a type of anticonvulsants called benzodiazepines.
    • Patients and their caretakers may have access to rescue medications and know how to use them.

    What if it’s not a seizure?


    If a bystander does not witness a seizure, but instead finds someone unresponsive or minimally responsive, call 911. They may be suffering from other medical issues, such as a drug overdose. And if you are interested in training and certification for seizure first aid, or if you simply want to know more, the Epilepsy Foundation has more information.

    • Jacob Pellinen has received research support from the Department of Neurology at the University of Colorado School of Medicine, the Colorado Clinical and Translational Sciences Institute, NIH/NINDS, and the American Epilepsy Society.
    • J. Pellinen serves as chair of the professional advisory board for the Epilepsy Foundation of Colorado and Wyoming (unpaid), serves as the Epilepsy Section Editor for Current Neurology and Neuroscience Reports, and has received compensation for serving on the scientific advisory board for SK Life Science.

    Why it’s a bad idea to mix alcohol with some medications

    Retrieved on: 
    星期一, 二月 12, 2024

    But you may not be aware that mixing certain medicines with alcohol can increase the effects and put you at risk.

    Key Points: 
    • But you may not be aware that mixing certain medicines with alcohol can increase the effects and put you at risk.
    • When you mix alcohol with medicines, whether prescription or over-the-counter, the medicines can increase the effects of the alcohol or the alcohol can increase the side-effects of the drug.
    • This is because there is less water in their bodies that can mix with the alcohol.
    • If you do want to drink alcohol while being on medication, discuss it with your doctor or pharmacist first.