Weight gain

Fabre-Kramer Pharmaceuticals Announces FDA Approval of EXXUA™, the First and Only Oral Selective 5HT1a Receptor Agonist for the Treatment of Major Depressive Disorder in Adults

Retrieved on: 
Thursday, September 28, 2023
Blood pressure, DBSA, Depression, University, DSM-IV codes, Pharmacy, COVID-19, Quality of life, University of California, Gepirone, CNS, Weight gain, University of Virginia School of Medicine, Fabre-Kramer Pharmaceuticals, Dizziness, MDD, Severe cutaneous adverse reactions, MD, Patient, NCE, Effectiveness, Grammatical mood, Nausea, Heart rate, FDA, Regulation of tobacco by the U.S. Food and Drug Administration, Neurology, Virginia School for Girls, Food, Chair, Pharmaceutical industry, Dietary supplement, Psychiatry

HOUSTON, Sept. 28, 2023 /PRNewswire/ -- Fabre-Kramer Pharmaceuticals Inc. (Fabre-Kramer), a biopharmaceutical company committed to developing novel therapies to address unmet needs in psychiatry and neurology, is pleased to announce that the U.S. Food and Drug Administration (FDA) has approved Exxua™ (gepirone hydrochloride extended-release tablets) for the treatment of major depressive disorder (MDD) in adults. Exxua represents a new class of antidepressant; the first and only approved antidepressant with a novel mechanism of action that selectively targets the serotonin 1A receptor, a key regulator of mood and emotion. Exxua has been shown to effectively relieve depressive symptoms, and its approved labeling does not contain Warnings or Adverse Reactions regarding causing sexual dysfunction or weight gain vs. placebo. Exxua is expected to be available in pharmacies in early 2024.

Key Points: 
  • EXXUA is the first new chemical entity (NCE) utilizing this single mechanism approved for the treatment of major depressive disorder.
  • Exxua has been shown to effectively relieve depressive symptoms, and its approved labeling does not contain Warnings or Adverse Reactions regarding causing sexual dysfunction or weight gain vs. placebo.
  • Studied in over 5,000 patients, EXXUA's unique mechanism of targeted single serotonin (5HT) 1a receptor agonism relieves depressive symptoms with an acceptable side effect profile.
  • Over 20 million American adults experienced major depressive disorder each year prior to the COVID-19 pandemic.

Phenomix Sciences Co-Founders Awarded First Patent for Using Precision Medicine and Phenotyping to Treat Obesity

Retrieved on: 
Thursday, September 28, 2023
Patent, Mayo Clinic, Obesity, Diet, Single-nucleotide polymorphism, United States Patent and Trademark Office, Weight gain, Hormone, Patient, Medicine, Phenotype, Gene, Disease, Soft drink, Pharmaceutical industry

MENLO PARK, Calif., Sept. 28, 2023 /PRNewswire/ -- Phenomix Sciences (Phenomix), a precision medicine biotechnology company that brings data-driven precision medicine to obesity treatment, announced today the United States Patent and Trademark Office (USPTO) has issued the first patent related to its obesity phenotyping technology.

Key Points: 
  • MENLO PARK, Calif., Sept. 28, 2023 /PRNewswire/ -- Phenomix Sciences (Phenomix), a precision medicine biotechnology company that brings data-driven precision medicine to obesity treatment, announced today the United States Patent and Trademark Office (USPTO) has issued the first patent related to its obesity phenotyping technology.
  • The patent applications are directed to various aspects of personalized obesity medicine, including foundational obesity phenotyping technology, analytical and computer implemented methods, phenotype-related lifestyle interventions and specific predictors of drug response.
  • "This patent serves as a testament to the value of obesity phenotyping and the substantial contributions it offers in addressing the disease."
  • "This first patent grant is the first of numerous patents filed, covering the strides made in obesity phenotyping over the past five years.

Tracking daily step counts can be a useful tool for weight management – an exercise scientist parses the science

Retrieved on: 
Thursday, September 28, 2023
Weight, Exercise, Appetite, Obesity, Food, Health, Diet, Body composition, Prevalence, U.S. Department of Defense Strategy for Operating in Cyberspace, Kennesaw, Georgia, Facial muscles, Human services, Health status of Asian Americans, Weight loss, Kennesaw State University, Research, Burn, Meta-analysis, Weight gain, Man, Walking, Population, Eating, Time, Overweight, Conditional sentence, Office of Inspector General, U.S. Department of Health and Human Services, News, Human, Dietary supplement, Property insurance, Pig, Copper

Among the most common, and arguably the most meaningful, tracking method for daily physical activity is step counting.

Key Points: 
  • Among the most common, and arguably the most meaningful, tracking method for daily physical activity is step counting.
  • Counting steps is far more than a fad: The U.S. Department of Health and Human Services dedicated a sizable portion of its most recent physical activity guidelines to documenting the relationship between daily step counts and several chronic diseases.
  • Unfortunately, the guidelines have little to say about how step counts might be used to aid in weight management, an outcome of critical importance given the high rates of overweight and obesity in the U.S.
  • I am a professor of exercise science at Kennesaw State University, and our lab has been conducting studies examining relationships among step counts and a number of health outcomes.

Step counts may – or may not – lead to weight loss

    • A number of recent studies have looked at whether increasing step counts can lead to weight loss over a certain period of time.
    • One large-scale study called a meta-analysis concluded that increasing physical activity by way of step counts was effective for attaining modest weight loss.
    • My team’s research has compiled weight, body fat percentages and average step counts for large numbers of adults between 19 and 40 years of age.

Parsing the numbers

    • We have used our data to develop a model that predicts average daily step counts per unit of fat mass from body fat percentage.
    • Take, for instance, a man who weighs 175 pounds (80 kilograms), of which 25% is fat.
    • Although they have different amounts of lean mass, both men have about 44 pounds (20 kilograms) of fat.
    • In other words, the heavier person has a lower percentage of body fat and walks more to maintain that leaner body composition.

Step counts for weight loss

    • With our model, you must determine your body weight and fat weight in kilograms – to do this, simply divide your weight in pounds by 2.2.
    • With this information in hand, our model can provide a step count target that is specific to a person’s current body weight and body fat percentage, and their goal for fat loss and weight reduction.
    • So even with a comfortable pace, this additional daily dose of walking would take fewer than 30 minutes.

KarXT, invented at PureTech, submitted for FDA Approval in Schizophrenia

Retrieved on: 
Thursday, September 28, 2023
Science, Biotechnology, Research, Pharmaceutical, General Health, Health, FDA, Mental Health, Psychiatry, PANSS, LSE, Somnolence, New Drug Application, Food and Drug Administration, NDA, PureTech Health, Weight gain, Extrapyramidal symptoms, Patient, Nature, Treatment, KRTX, Marder, Therapy, Pharmacology, Regulation of food and dietary supplements by the U.S. Food and Drug Administration, PRTC, Food, Safety, Pharmaceutical industry, KarXT, Schizophrenia

“We are thrilled to note this additional exciting milestone from the KarXT program, following the achievement of three successful, registration enabling studies in schizophrenia.

Key Points: 
  • “We are thrilled to note this additional exciting milestone from the KarXT program, following the achievement of three successful, registration enabling studies in schizophrenia.
  • The NDA submission is supported by efficacy and long-term safety data from the EMERGENT program, the clinical program evaluating KarXT as a treatment for schizophrenia.
  • The NDA submission is supported by efficacy and long-term safety data from the EMERGENT program, the clinical program evaluating KarXT as a treatment for schizophrenia.
  • Discontinuation rates due to treatment emergent adverse events were low and similar between KarXT and placebo across all trials.

Karuna Therapeutics Submits New Drug Application to U.S. Food and Drug Administration for KarXT for the Treatment of Schizophrenia

Retrieved on: 
Thursday, September 28, 2023
FDA, Health, Neurology, Clinical Trials, Pharmaceutical, Biotechnology, Psychiatry, PANSS, Somnolence, NDA, Weight gain, Extrapyramidal symptoms, Patient, Nature, KRTX, Marder, Therapy, Regulation of food and dietary supplements by the U.S. Food and Drug Administration, Food, Safety, Pharmaceutical industry, KarXT, Schizophrenia

It is also a defining moment for Karuna Therapeutics.

Key Points: 
  • It is also a defining moment for Karuna Therapeutics.
  • The NDA submission is supported by efficacy and long-term safety data from the EMERGENT program, the clinical program evaluating KarXT as a treatment for schizophrenia.
  • Discontinuation rates due to treatment emergent adverse events were low and similar between KarXT and placebo across all trials.
  • Notably, KarXT was not associated with common side effects of currently available antipsychotics, including changes in metabolic function, weight gain, somnolence, and extrapyramidal symptoms.

Rhythm Pharmaceuticals Receives Orphan Drug Designation from European Medicines Agency for Setmelanotide for Treatment of Acquired Hypothalamic Obesity

Retrieved on: 
Tuesday, September 19, 2023
Polyphagia, Brain, Obesity, International, European Medicines Agency, Rhythm, Weight gain, Astrocytoma, EMA, Patient, Medicine, European, MC4R, Diagnosis, Growth, United, Hunger, Craniopharyngioma, Disease, Pharmaceutical industry

“Acquired hypothalamic obesity is a serious disease with severe implications for patients and families and no effective treatment options,” said Yann Mazabraud, Executive Vice President and Head of International at Rhythm.

Key Points: 
  • “Acquired hypothalamic obesity is a serious disease with severe implications for patients and families and no effective treatment options,” said Yann Mazabraud, Executive Vice President and Head of International at Rhythm.
  • Rhythm is evaluating setmelanotide in a global Phase 3 clinical trial in acquired hypothalamic obesity and expects to complete patient enrollment in the fourth quarter of 2023.
  • Acquired hypothalamic obesity is a rare form of extreme obesity that occurs following damage to the hypothalamic region of the brain, which includes the MC4R pathway and is responsible for controlling physiological functions such as hunger and weight regulation.
  • Rhythm estimates there are approximately 3,500 to 10,000 patients living with acquired hypothalamic obesity in the European countries of Germany, France, Spain, Italy, The Netherlands, and the United Kingdom.1

Touchstone Essentials Launches New Blood Sugar Support Supplement Gluco-Control

Retrieved on: 
Wednesday, September 20, 2023
Starch, Insulin resistance, Food, Quality of life, Rock (geology), Research, Centers for Disease Control and Prevention, Weight gain, CDC, Capsule, Prediabetes, The Non-GMO Project, System, Health, Hunger, Probiotic, Essential, Dietary supplement, Copper

RALEIGH, N.C., Sept. 20, 2023 /PRNewswire/ -- Eddie Stone, the Founder and CEO of the global direct selling e-commerce wellness company, Touchstone Essentials, has officially announced the launch of a revolutionary all-natural supplement to support healthy blood sugar.

Key Points: 
  • Touchstone Essentials, a detox and organic supplement direct sales company, has launched a new blood sugar support supplement called Gluco-Control.
  • RALEIGH, N.C., Sept. 20, 2023 /PRNewswire/ -- Eddie Stone, the Founder and CEO of the global direct selling e-commerce wellness company, Touchstone Essentials, has officially announced the launch of a revolutionary all-natural supplement to support healthy blood sugar.
  • These troubling trends led Eddie Stone to seek out a natural approach to support healthy blood sugar .
  • Gluco-Control was developed with a unique glucose control complex featuring glucose-converting enzymes, organic mushrooms, and probiotics to provide natural blood sugar support.

Alkermes Presents Clinical and Real-World Data at 36th Annual Psych Congress

Retrieved on: 
Monday, September 11, 2023
Psych, PANSS, Olanzapine, Wellness, Bipolar I disorder, Addiction, Paliperidone palmitate, COVID-19, Humanism, ARISTADA, Observational study, Signs and symptoms, Initiation, Lais, Research, Meta-analysis, Patient, Diagnosis, ALKS, Congress, Neuroscience, Alkermes, Aripiprazole lauroxil, Post hoc analysis, Conditional sentence, Clinical, Human, Treatment, Weight gain, Pharmaceutical industry, Paliperidone, Narcolepsy, Schizophrenia

DUBLIN, Sept. 11, 2023 /PRNewswire/ -- Alkermes plc (Nasdaq: ALKS) today announced the presentation of multiple posters highlighting real-world and clinical data at the 36th Annual Psych Congress (Psych Congress), which took place Sept. 6-10, 2023 in Nashville. This research reflects the company's continued commitment to improving care for, and understanding the unique needs of, people living with serious chronic diseases.

Key Points: 
  • — Poster Presentations Highlight Company's Broad Research Commitment to Serious Mental Illness, Addiction and Narcolepsy —
    DUBLIN, Sept. 11, 2023 /PRNewswire/ -- Alkermes plc (Nasdaq: ALKS) today announced the presentation of multiple posters highlighting real-world and clinical data at the 36th Annual Psych Congress (Psych Congress), which took place Sept. 6-10, 2023 in Nashville.
  • This research reflects the company's continued commitment to improving care for, and understanding the unique needs of, people living with serious chronic diseases.
  • "Psych Congress offers an important opportunity for scientific exchange and information sharing as we seek to advance care for people living with serious, complex diseases.
  • This year's presentations further reinforce Alkermes' leadership and experience in the field of neuroscience," said Craig Hopkinson, M.D., Chief Medical Officer and Executive Vice President of Research & Development at Alkermes.

Alkermes Presents Clinical and Real-World Data at 36th Annual Psych Congress

Retrieved on: 
Monday, September 11, 2023
Psych, PANSS, Olanzapine, Wellness, Bipolar I disorder, Addiction, Paliperidone palmitate, COVID-19, Humanism, ARISTADA, Observational study, Signs and symptoms, Initiation, Lais, Research, Meta-analysis, Patient, Diagnosis, ALKS, Congress, Neuroscience, Alkermes, Aripiprazole lauroxil, Post hoc analysis, Conditional sentence, Clinical, Human, Treatment, Weight gain, Pharmaceutical industry, Paliperidone, Narcolepsy, Schizophrenia

DUBLIN, Sept. 11, 2023 /PRNewswire/ -- Alkermes plc (Nasdaq: ALKS) today announced the presentation of multiple posters highlighting real-world and clinical data at the 36th Annual Psych Congress (Psych Congress), which took place Sept. 6-10, 2023 in Nashville. This research reflects the company's continued commitment to improving care for, and understanding the unique needs of, people living with serious chronic diseases.

Key Points: 
  • — Poster Presentations Highlight Company's Broad Research Commitment to Serious Mental Illness, Addiction and Narcolepsy —
    DUBLIN, Sept. 11, 2023 /PRNewswire/ -- Alkermes plc (Nasdaq: ALKS) today announced the presentation of multiple posters highlighting real-world and clinical data at the 36th Annual Psych Congress (Psych Congress), which took place Sept. 6-10, 2023 in Nashville.
  • This research reflects the company's continued commitment to improving care for, and understanding the unique needs of, people living with serious chronic diseases.
  • "Psych Congress offers an important opportunity for scientific exchange and information sharing as we seek to advance care for people living with serious, complex diseases.
  • This year's presentations further reinforce Alkermes' leadership and experience in the field of neuroscience," said Craig Hopkinson, M.D., Chief Medical Officer and Executive Vice President of Research & Development at Alkermes.

Bipolar disorder isn't the same for everyone. So people should have more say in how they're treated

Retrieved on: 
Thursday, August 31, 2023
People, Lamotrigine, Hallucination, Depression, Anxiety, Life, Diabetes, Bipolar II disorder, Suicide, Sleep, Psychopharmacology, Deficit spending, Bipolar I disorder, Delusion, Research, Weight gain, Black Dog Institute, Thought, DSM-IV codes, Population, Patient, Risk, Black, Psychiatry, Pleasure, Motivation, Personality, Intermittent explosive disorder, Mental health, Medication, Bipolar disorder, Lithium, Medical device, Pharmaceutical industry

Around 2% of the adult population have a bipolar disorder.

Key Points: 
  • Around 2% of the adult population have a bipolar disorder.
  • Certain medications may be more beneficial for certain types of bipolar disorder, but how do you know which “type” you or a loved one has?
  • A new approach is needed that places emphasis on “real-world” effectiveness and respects the observations of people with bipolar disorder.

Two types of bipolar disorder

    • Originally called “manic-depressive psychosis”, it is now known as bipolar I disorder.
    • In the mid-1990s, bipolar II disorder was defined.
    • Both bipolar I and bipolar II are marked by pronounced mood swings.
    • The key distinguishing feature between the two bipolar conditions is the presence of psychotic features (delusions and/or hallucinations) in those with bipolar I.

Current treatments

    • Melbourne psychiatrist John Cade discovered the effectiveness of lithium as a treatment for manic depression in 1949.
    • This landmark research ushered in the era of condition-specific psychopharmacology.
    • Practitioners refer to research-based guidelines to determine the best medications to help stabilise a bipolar disorder.

But evidence isn’t everything

    • All were “evidence-based”, but we found minimal agreement between them, thus raising questions about their validity.
    • New guidelines have been published since then but the trend for minimal agreement continues.
    • Assessing a psychiatric evidence base is difficult.

Accounting for side effects

    • However, it has multiple side effects.
    • But 50% of the completers receiving lithium experienced distinctive cognitive impairment – side effects that affected their thinking and reasoning.
    • Many of the antipsychotic drugs nominated in guidelines also have major side effects, including weight gain and diabetes.
    • People who are stable while taking these medications without major side effects should not be alarmed.

We want to hear from people with bipolar disorders


    All these concerns highlight the need for research focused on “real-world” samples to determine the best treatments that consider each person’s responses to any medication. We are conducting such a study now, in collaboration with the Black Dog Institute. If you are interested, you can access the study here. Gordon Parker receives funding from the Australian National Health and Medical Research Council.