Benzodiazepine

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: 
Wednesday, March 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: 
Thursday, March 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: 
Thursday, March 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: 
Wednesday, February 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: 
Wednesday, February 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

      Page 2/12

      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: 
Wednesday, February 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: 
Monday, February 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.

How Psychedelic-Based Therapeutics Are Advancing in Treating Generalized Anxiety Disorder (GAD) Condition

Retrieved on: 
Wednesday, January 24, 2024

PALM BEACH, Fla., Jan. 24, 2024 /PRNewswire/ -- The coming years could see a massive shift in the U.S. government's approach to regulating hallucinogenic drugs. Several biopharma companies are developing psychedelics-based treatments for various mental health conditions like Generalized Anxiety Disorder (GAD). GAD is a prevalent mental health condition characterized by excessive and persistent worry, often extending beyond specific triggers. Individuals with GAD experience heightened levels of anxiety, anticipating future events and exhibiting physical symptoms such as muscle tension and restlessness. The disorder significantly impairs daily functioning and quality of life. A report from Delveinsight said that the total market size of the Generalized Anxiety Disorder (GAD) treatment market is anticipated to experience growth during the forecast period (2032) due to the emergence of new and effective treatments, especially numerous trials developing new and innovative next-generation psychedelic treatment options. The report added: "The diagnosis of Generalized Anxiety Disorder (GAD) involves a comprehensive assessment of an individual's mental health, considering the presence of excessive and uncontrollable worry across various aspects of life for a minimum of six months. Clinicians utilize standardized psychiatric interviews and validated screening tools to evaluate the severity of anxiety symptoms, along with a thorough exploration of associated physical and psychological manifestations. Differential diagnosis is crucial to rule out other psychiatric conditions, medical disorders, or substance-related issues that may mimic GAD symptoms. The diagnostic process also entails considering the impact of anxiety on daily functioning and its persistence in the absence of identifiable stressors. A multidimensional approach aids in ensuring an accurate diagnosis and facilitates the development of an effective treatment plan tailored to the individual's needs." Active Companies active today in markets include: Cybin Inc. (NYSE: CYBN) (NEO: CYBN), COMPASS Pathways plc (NASDAQ: CMPS), Mind Medicine (MindMed) Inc. (NASDAQ: MNMD) (NEO: MMED), Seelos Therapeutics, Inc. (NASDAQ: SEEL), atai Life Sciences (NASDAQ: ATAI).

Key Points: 
  • Several biopharma companies are developing psychedelics-based treatments for various mental health conditions like Generalized Anxiety Disorder (GAD).
  • It continued: "DelveInsight's analyst projects that among the total diagnosed prevalent cases of Generalized Anxiety Disorder (GAD) in 7MM approximately 53% of cases were from the US.
  • The Generalized Anxiety Disorder (GAD) market is projected to witness consistent growth throughout the forecast period (2023–2032).
  • The market size of Generalized Anxiety Disorder (GAD) in the 7MM is expected to increase, driven by better diagnosis and the launch of emerging therapies."

How Psychedelic-Based Therapeutics Are Advancing in Treating Generalized Anxiety Disorder (GAD) Condition

Retrieved on: 
Wednesday, January 24, 2024

PALM BEACH, Fla., Jan. 24, 2024 /PRNewswire/ -- The coming years could see a massive shift in the U.S. government's approach to regulating hallucinogenic drugs. Several biopharma companies are developing psychedelics-based treatments for various mental health conditions like Generalized Anxiety Disorder (GAD). GAD is a prevalent mental health condition characterized by excessive and persistent worry, often extending beyond specific triggers. Individuals with GAD experience heightened levels of anxiety, anticipating future events and exhibiting physical symptoms such as muscle tension and restlessness. The disorder significantly impairs daily functioning and quality of life. A report from Delveinsight said that the total market size of the Generalized Anxiety Disorder (GAD) treatment market is anticipated to experience growth during the forecast period (2032) due to the emergence of new and effective treatments, especially numerous trials developing new and innovative next-generation psychedelic treatment options. The report added: "The diagnosis of Generalized Anxiety Disorder (GAD) involves a comprehensive assessment of an individual's mental health, considering the presence of excessive and uncontrollable worry across various aspects of life for a minimum of six months. Clinicians utilize standardized psychiatric interviews and validated screening tools to evaluate the severity of anxiety symptoms, along with a thorough exploration of associated physical and psychological manifestations. Differential diagnosis is crucial to rule out other psychiatric conditions, medical disorders, or substance-related issues that may mimic GAD symptoms. The diagnostic process also entails considering the impact of anxiety on daily functioning and its persistence in the absence of identifiable stressors. A multidimensional approach aids in ensuring an accurate diagnosis and facilitates the development of an effective treatment plan tailored to the individual's needs." Active Companies active today in markets include: Cybin Inc. (NYSE: CYBN) (NEO: CYBN), COMPASS Pathways plc (NASDAQ: CMPS), Mind Medicine (MindMed) Inc. (NASDAQ: MNMD) (NEO: MMED), Seelos Therapeutics, Inc. (NASDAQ: SEEL), atai Life Sciences (NASDAQ: ATAI).

Key Points: 
  • Several biopharma companies are developing psychedelics-based treatments for various mental health conditions like Generalized Anxiety Disorder (GAD).
  • It continued: "DelveInsight's analyst projects that among the total diagnosed prevalent cases of Generalized Anxiety Disorder (GAD) in 7MM approximately 53% of cases were from the US.
  • The Generalized Anxiety Disorder (GAD) market is projected to witness consistent growth throughout the forecast period (2023–2032).
  • The market size of Generalized Anxiety Disorder (GAD) in the 7MM is expected to increase, driven by better diagnosis and the launch of emerging therapies."

ZURZUVAE™ (zuranolone) CIV, a Landmark Oral Treatment for Women with Postpartum Depression (PPD), is Now Available in the U.S.

Retrieved on: 
Thursday, December 14, 2023

CAMBRIDGE, Mass., Dec. 14, 2023 (GLOBE NEWSWIRE) -- Biogen Inc. (Nasdaq: BIIB) and Sage Therapeutics, Inc. (Nasdaq: SAGE) announced ZURZUVAE™ (zuranolone) 50 mg (two 25 mg capsules per day) CIV is now available by prescription for the treatment of postpartum depression (PPD) for adults in the United States, with product already at specialty pharmacies and delivered to patients. ZURZUVAE is the first and only oral, 14-day treatment course for adults with PPD that can provide rapid improvements in depressive symptoms at Day 15 and as early as Day 3.

Key Points: 
  • “For women with PPD, delayed improvement in depressive symptoms can significantly worsen outcomes.
  • The program also includes financial assistance, such as a copay assistance program, and product at no cost for eligible patients.
  • The companies are partnering with several of the leading national specialty pharmacies and ZURZUVAE will be shipped directly to women with PPD who are prescribed the treatment.
  • ZURZUVAE is not for use in children
    How can I watch for and try to prevent suicidal thoughts and actions?