Advances in Therapy

New Study Publication Demonstrates Eye Health and Cognitive Benefits of Lutein and Zeaxanthin from Lutemax Kids

Retrieved on: 
Wednesday, February 21, 2024
Cognitive science, Female, Lutein, Parent, Mental, Advances in Therapy, Eye, University, Attention, Vegetable, Nutrient, Carotenoid, Cognition, Male, Behavior, American Academy

BRIDGEWATER, N.J. and MUMBAI, India , Feb. 21, 2024 /PRNewswire/ -- Six in ten parents regularly worry about their child's eye health, prioritizing it above other well-being needs; however, they are unfamiliar with ways to support it. This finding is according to a OmniActive Health Technologies U.S. parent survey for its "Lutein for Every Age" educational initiative, which focuses on raising awareness of early and consistent lutein and zeaxanthin intake to help support eye, cognitive, and general health throughout life.

Key Points: 
  • The publication revealed that Lutemax Kids resulted in significant improvements in aspects of vision performance and cognition.
  • "This study is an important milestone for eye health and cognitive science, laying the groundwork for further understanding on how lutein and zeaxanthin can impact younger populations.
  • Lutemax Kids , a line extension of OmniActive's pioneering lutein and zeaxanthin extract brand Lutemax 2020, is a lower dose to help meet the nutritional needs of children.
  • To learn more about how to support eye and brain health visit Lutemax.com/lfea and to find supplements that feature the Lutemax ingredient, visit Lutemax.com/where-to-buy .

Better Therapeutics Announces Publication of Cost-Effectiveness Analysis Demonstrating AspyreRx is More Effective and Less Costly than Standard of Care Alone

Retrieved on: 
Wednesday, January 17, 2024
Oncology, Health, Hospitals, General Health, Clinical Trials, Pharmaceutical, Biotechnology, Diabetes, Patient, Therapy, Quality-adjusted life year, SOC, Society, Digital, Type 2 diabetes, American Diabetes Association, Better, Cognitive behavioral therapy, Advances in Therapy, ICER, A1C, QALY, Life imprisonment, Prevalence, Pharmaceutical industry

The study's authors conclude that, from a healthcare payer perspective, AspyreRx plus standard of care (SoC) was estimated to be both economically and clinically superior to SoC alone over the lifetime horizon.

Key Points: 
  • The study's authors conclude that, from a healthcare payer perspective, AspyreRx plus standard of care (SoC) was estimated to be both economically and clinically superior to SoC alone over the lifetime horizon.
  • This suggests that the use of AspyreRx can empower patients to better manage their diabetes with the potential for lifelong advantages.
  • This latest study modeled the cost-effectiveness of AspyreRx plus SoC versus SoC alone in T2D over a lifetime horizon.
  • "The publication of this data, demonstrating that adding AspyreRx to standard of care has the potential to be more effective and less costly than standard of care alone, exemplifies our vision to make societies healthier and meaningfully reduce healthcare costs.”

Avadel Pharmaceuticals Announces Publication of Study Data in Advances in Therapy Highlighting Need for Once-at-Bedtime Oxybate Dosing for Narcolepsy

Retrieved on: 
Tuesday, June 13, 2023
Narcolepsy, Cataplexy, Doctor of Pharmacy, Senior, Gamma-Hydroxybutyric acid, Geisinger Medical Center, DCE, Discrete, Anxiety, Quality of life, Advances in Therapy, Patient, Somnolence, Neurology, Sodium, Developmental Medicine & Child Neurology, Pharmaceutical industry, Medical imaging, Child

The paper, titled “Clinician Preferences for Oxybate Treatment for Narcolepsy: Survey and Discrete Choice Experiment,” was published in Advances in Therapy and can be accessed here .

Key Points: 
  • The paper, titled “Clinician Preferences for Oxybate Treatment for Narcolepsy: Survey and Discrete Choice Experiment,” was published in Advances in Therapy and can be accessed here .
  • “Sodium oxybate has been recognized as a standard of care to treat narcolepsy for more than 20 years, but, until recently, has required two nighttime doses for sufficient therapy.
  • These data underscore the long unmet need for an oxybate treatment that does not require middle-of-the-night dosing.
  • “These data provide insight that the most important driver of oxybate choice is dosing and not sodium content.”

Helsinn announces publication of data evaluating impact of AKYNZEO® (fosnetupitant/palonosetron) on treatment outcomes and healthcare costs

Retrieved on: 
Monday, June 12, 2023
Palonosetron, Nausea, FACP, Agency for Healthcare Research and Quality, CINV, Antiemetic, Advances in Therapy, APPA, Pharmacy, Doctor of Philosophy, Quality, GLM, Vomiting, Cancer, MD, Patient, Data, Agency, Lead author, Rare, Pharmaceutical industry, Health insurance, Pet industry, Hospital

The dataset provides insight to nearly 80% of the US healthcare system, with patient-level data from all provider types.

Key Points: 
  • The dataset provides insight to nearly 80% of the US healthcare system, with patient-level data from all provider types.
  • Referring to the details of the publication below, these real-world data showed that healthcare resource utilization, such as CINV-related visits were significantly lower after AKYNZEO® compared to fosaprepitant/palonosetron (APPA).
  • CINV-related healthcare costs were also statistically and/or numerically lower for patients receiving AKYZNEO® compared to APPA.
  • There remains a gap between expected and actual patient outcomes as clinicians translate trial data and clinical guidelines into practice.

Rhythm Pharmaceuticals Reports First Quarter 2023 Financial Results and Business Update

Retrieved on: 
Tuesday, May 2, 2023
LEPR, Polyphagia, Obesity, Food, International, Completeness, Body mass index, Bardet–Biedl syndrome, Food and Drug Administration, Clinical trial, Prescription, G&A, Advances in Therapy, Research, Ratio, POMC, BBS, CHI, Data analysis, Phase 3, Patient, Investment, Physician, PCSK1, National Association of Statutory Health Insurance Physicians, Webcast, MC4R, Ageing, R, BMI, FDA, Hunger, Acquisition, Human, Congenital hyperinsulinism, D, Pharmaceutical industry, Cryptocurrency, Rhythm, S

-- Management to host conference call today at 8:00 a.m. ET --

Key Points: 
  • ET --
    BOSTON, May 02, 2023 (GLOBE NEWSWIRE) -- Rhythm Pharmaceuticals, Inc. (Nasdaq: RYTM), a global commercial-stage biopharmaceutical company focused on transforming the lives of patients and their families living with hyperphagia and severe obesity caused by rare melanocortin-4 receptor (MC4R) pathway diseases, today reported financial results and provided a business update for the first quarter ended March 31, 2023.
  • R&D Expenses: R&D expenses were $37.9 million in the first quarter of 2023, as compared to $32.5 million in the first quarter of 2022.
  • S,G&A Expenses: S,G&A expenses were $24.6 million for the first quarter of 2023, as compared to $21.4 million for the first quarter of 2022.
  • ET today to review its first quarter 2023 financial results and recent business activities.

Rhythm Pharmaceuticals Announces Publication of Bardet-Biedl Syndrome Patient and Caregiver Perspectives of Hunger and Quality of Life with Setmelanotide

Retrieved on: 
Monday, March 27, 2023
Polyphagia, Faculty, University of Alberta, Obesity, Food, University, Use, Phase II, Stroke, Weight loss, Bardet–Biedl syndrome, Eating, Quality of life, Advances in Therapy, Research, BBS, Patient, Child, MC4R, University of Melbourne Faculty of Medicine, Dentistry and Health Sciences, Regulation of food and dietary supplements by the U.S. Food and Drug Administration, Caregiver, Medicine, Pharmaceutical industry, Residential care, Rhythm, Syndrome, Hunger

BOSTON, March 27, 2023 (GLOBE NEWSWIRE) -- Rhythm Pharmaceuticals, Inc. (Nasdaq: RYTM), a commercial-stage biopharmaceutical company focused on transforming the lives of patients and their families living with hyperphagia and severe obesity caused by rare melanocortin-4 receptor (MC4R) pathway diseases, today announced the publication of interview-based patient and caregiver reported experiences of hunger and quality of life with setmelanotide treatment in Bardet-Biedl syndrome (BBS). The research is published in the peer-reviewed journal Advances in Therapy.

Key Points: 
  • A total of 19 interviews were conducted with patients (n=8) and caregivers (n=11) to explore patient experience and caregiver observations of hyperphagia before and during setmelanotide treatment.
  • Before setmelanotide treatment, most patients (n=7; 87.5%) and caregivers (n=10; 90.9%) experienced negative effects directly related to hyperphagia.
  • “Until now, the impact of hyperphagia on the lives of these patients and their families has not been fully understood.
  • These data can be incorporated into cost-utility models conducted to assess the value of treatments for rare MC4R pathway diseases.

Wellbeing Subsidiary KGK Science Announces Successful Delivery of CBD and THC Through the Skin of Healthy Volunteers

Retrieved on: 
Monday, November 14, 2022
Science, Research, Pharmaceutical, Alternative Medicine, General Health, Health, Mental Health, Clinical Trials, Blood, Skin, GT4, OTC, Pediatrics, KGK, Drug development, Epilepsy, Patient, FRA, Science, Gefion, Human, Research, Advances in Therapy, SQ2, Volunteering, MEDI, THC, Therapy, Digital Science, Cannabinoid, Database, NEO, Publication, Medical device, Pharmaceutical industry, CBD

Gefion GT4 technology uses novel penetrating agents to transport CBD and THC through the skin and directly into the blood.

Key Points: 
  • Gefion GT4 technology uses novel penetrating agents to transport CBD and THC through the skin and directly into the blood.
  • Transdermal delivery of topically-applied cannabinoids can be difficult and prior to this study, published research demonstrating successful topical delivery did not exist.
  • The Gefion Canada study, published in Advances in Therapy , showed for the first time that CBD and THC were successfully transported into the blood stream following application to the skin.
  • Importantly, CBD and THC delivery in this study was found to be safe and well tolerated by all participants.

Urovant Sciences Announces Publication in Advances in Therapy of Analyses of Patient-Perceived Meaningfulness of Improvement in Symptom Reduction for Overactive Bladder Patients Treated with GEMTESA® (vibegron) 75 mg

Retrieved on: 
Monday, December 20, 2021
Research, Clinical Trials, Biotechnology, Other Health, Health, Pharmaceutical, General Health, Other Science, Science, Doctor of Philosophy, Urinary incontinence, Vibegron, OAB, FDA, American Urological Association, Urology, ICS, AUA, Overactive bladder, MD, Semantics, Advances in Therapy, Perception, Micturition syncope, SUNA, Pharmaceutical industry, Medical imaging, Patient, the Analysis, Overactive Bladder, GEMTESA®, Urovant Sciences, THE ANALYSIS, OVERACTIVE BLADDER, GEMTESA®, UROVANT SCIENCES

These significantly higher proportions of patients achieving pre-defined patient-perceived symptom improvements are likely to inform patients and providers in establishing realistic treatment goals.

Key Points: 
  • These significantly higher proportions of patients achieving pre-defined patient-perceived symptom improvements are likely to inform patients and providers in establishing realistic treatment goals.
  • The publication in a peer-reviewed journal is another example of Urovants commitment to informing the scientific medical community about meaningful effects of GEMTESA.
  • Although OAB is highly prevalent among adults; large clinical studies often neglect to report patient perceptions of the meaningfulness of symptom improvement.
  • The new publication describes a method to derive meaningful within-patient change using a patient-reported measure, the Patient Global Impression of Change (PGI-C).

US FDA approved IND submitted by Pharmazz, Inc. to initiate a phase III clinical trial of centhaquine in patients with hypovolemic shock

Retrieved on: 
Wednesday, September 29, 2021
Blood, Vomiting, Hypovolemic shock, Mortality, Cardiac output, Trauma, Resuscitation, Gastrointestinal bleeding, Standard of care, Patient, Time-invariant system, Therapy, Advances in Therapy, Private Securities Litigation Reform Act, III, FDA, Blood volume, Phase, Acquisition, Company, Critical care, Meta-analysis, Internal bleeding, Risk, Hypovolemia, Bleeding, IND, Survival, Manuscript, Randomness, US, MODS, Diarrhea, Pharmaceutical industry

The Phase III clinical study will be a multi-centric, double-blind, placebo-controlled to be conducted on 430 patients randomly assigned equally to both arms with 28-day mortality as the primary endpoint.

Key Points: 
  • The Phase III clinical study will be a multi-centric, double-blind, placebo-controlled to be conducted on 430 patients randomly assigned equally to both arms with 28-day mortality as the primary endpoint.
  • Centhaquine, a resuscitative agent free of arterial constriction, IND for the Phase III trial approved by the US FDA
    Severe blood or fluid loss due to trauma, gastrointestinal bleeding, major surgery, postpartum hemorrhage, diarrhea, or vomiting can cause hypovolemic shock.
  • About 1.9 million people worldwide die because of hemorrhagic shock every year, most dying within the first 6 hours.
  • The peer-reviewed publication of the manuscript titled " A Multi-centric, Randomized, Controlled Phase III Study of Centhaquine (Lyfaquin) as a Resuscitative Agent in Hypovolemic Shock Patients."

Enzyvant Announces First-Ever Data on Burden of Illness and Costs of Supportive Care for Pediatric Congenital Athymia

Retrieved on: 
Thursday, August 26, 2021
ATMP, EMA, SCID, Life, Immunodeficiency, Family, Trauma, Caregiver, Food, T cell deficiency, Journal of Medical Economics, Immunology, Health care, Orphan drug, Immunosuppression, Time, Child, Sibling, European Medicines Agency, Sumitomo Dainippon Pharma, Hospital, Patient, Regulation of food and dietary supplements by the U.S. Food and Drug Administration, Friends, Twitter, Incidence, Diagnosis, Pediatrics, Advanced Therapy Medicinal Product, Sport, LinkedIn, FDA, Ministry of Education (Malaysia), Advances in Therapy, Journal, HCPS, Health, Birth defect, Literature, GLOBE, Infection, Physician, PDUFA, Fear, NYSE, BLA, Prescription Drug User Fee Act, Infant, Parent, Residential care, Pharmaceutical industry, Medicine, Dentistry, Health insurance, Machine tool

CAMBRIDGE, Mass. and BASEL, Switzerland, Aug. 26, 2021 (GLOBE NEWSWIRE) -- Data from two first-ever studies reveal extreme clinical, emotional, social, and financial burdens on patients with pediatric congenital athymia and their families, and extraordinary costs of supportive care to healthcare systems. Congenital athymia is an ultra-rare condition in which children are born without a thymus, leading to profound immunodeficiency, life-threatening immune dysregulation, and high susceptibility to potentially fatal infections. Estimated incidence of congenital athymia in the U.S. is ~17 to 24 live births each year.1 Currently, there are no FDA-approved treatments for congenital athymia.

Key Points: 
  • Supportive care is used to prevent potentially fatal infections and manage other symptoms of immunodeficiency and immune dysregulation due to congenital athymia.
  • With only supportive care, patients with congenital athymia typically die by age two or three.
  • To evaluate the burdens of congenital athymia on patients and families, and the total medical costs associated with supportive care, two separate studies were conducted.
  • Both the congenital athymia caregiver-assessed burden of illness and cost of supportive care studies were fully supported with funding from Enzyvant.