CYP2D6

Atossa Therapeutics Provides Five-Year (Z)-Endoxifen Treatment Update on FDA-Approved "Expanded Access" Program for a U.S. Breast Cancer Patient

Retrieved on: 
Tuesday, March 19, 2024
Diagnosis, Growth, Ki-67, Neoadjuvant therapy, Mammography, Cancer, Expanded access, Woman, Neoplasm, Therapy, Breast cancer, CYP2D6, Safety, Axis, Osteoporosis, Hot, Recurrence, Tamoxifen, FDA, Enzyme inhibitor, PR, Pharmaceutical industry

Atossa is a clinical stage biopharmaceutical company developing innovative medicines in areas of significant unmet medical need in oncology with a focus on breast cancer.

Key Points: 
  • Atossa is a clinical stage biopharmaceutical company developing innovative medicines in areas of significant unmet medical need in oncology with a focus on breast cancer.
  • Over five years of adjuvant treatment, her daily (Z)-endoxifen treatment has been well tolerated, and there were no vasomotor symptoms commonly associated with standard of care adjuvant pharmaceuticals.
  • She remains cancer-free today and we are grateful to have been able to help her with a difficult treatment problem.”
    Diagnosis.
  • Under the FDA Expanded Access IND program, the use of Atossa's proprietary (Z)-endoxifen is restricted to this patient only.

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

Retrieved on: 
Wednesday, February 14, 2024
Leptin, PD, Metabolism, Toxicity, Body composition, Ciprofloxacin, Clinical Pharmacokinetics, Water, LBW, Perfusion, LBM, Canadian International Council, AUC, PLOS One, Bariatric surgery, Clopidogrel, CYP, Breast, Health, DNA-binding protein, BMC Public Health, Pharmacology, BMI, CRP, Pharmaceutical Research (journal), Organ, Draft, Guideline, Bypass surgery, WHO, Ageing, INT, Pharmacokinetics, Liver, Bioavailability, Chronic liver disease, Human, Incidence, Committee, Absorption, TBW, Cardiovascular disease, Anatomy, CYP2C19, PBPK, Cmax, Factorization of polynomials, European, Lancet, CHMP, Journal, NASH, Pharmacotherapy, Adipose tissue, Non-alcoholic fatty liver disease, Journal of Clinical Investigation, Medication package insert, Overweight, NPS MedicineWise, Permeability, Benzodiazepine, Meta-analysis, Liver disease, Half-life, Acetylcholine, Ciclosporin, AAG, Kinetics, Midazolam, Kidney, Safety, Biomarker, Clinical Pharmacology & Therapeutics, Peptide, Classification, Hypertension, Metabolic syndrome, Acute coronary syndrome, Insulin resistance, Fatty liver disease, CYP2E1, Lithium, Body mass index, Reproduction, EMA, IBW, Injection, Anker, NCA, Enzyme, Inflammation, Cancer, Weight loss, Gastrointestinal tract, Cardiac output, Public health, Adipokine, CYP2C9, E pluribus unum, Physiology, Agency, Risk, Steroid, Lymph, CYP2D6, BSA, GI, Cytokine, Systematic review, Vaccine

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

Human medicines European public assessment report (EPAR): Cerdelga, eliglustat, Date of authorisation: 19/01/2015, Revision: 17, Status: Authorised

Retrieved on: 
Tuesday, January 2, 2024
Spleen, Patient, Liver, Medical Subject Headings, Marketing, Disease, INN, Metabolism, Fatigue, Heartburn, Fracture, ATC, Gaucher's disease, Capsule, International, Enzyme replacement therapy, Bone pain, Language, Mouth, CYP2D6, European Medicines Agency, Indigestion, EMS, Select, Instant messaging, Bruise, Safety, Anatomy, Anemia, IIA, Medical device

Human medicines European public assessment report (EPAR): Cerdelga, eliglustat, Date of authorisation: 19/01/2015, Revision: 17, Status: Authorised

Key Points: 


Human medicines European public assessment report (EPAR): Cerdelga, eliglustat, Date of authorisation: 19/01/2015, Revision: 17, Status: Authorised

Integrating Drug-Drug Interactions and Lifestyle Factors with Drug-Gene Interactions Provided by Castle Biosciences’ IDgenetix® Test Significantly Impacted the Number of Drug Recommendations for Patients with Moderate to Severe Depression

Retrieved on: 
Sunday, September 10, 2023
Mental Health, Health, Genetics, Research, Science, Pharmaceutical, Biotechnology, Psych, Depression, CYP2C19, RCT, Mental health, Patient, CYP2D6, Lifestyle, Grammatical mood, Poster, Smoking, Randomized controlled trial, HMP, Medication, Major depressive disorder, Pharmaceutical industry

Castle Biosciences, Inc. (Nasdaq: CSTL), a company improving health through innovative tests that guide patient care, today announced data from a study showing the addition of drug-drug interactions and lifestyle factors to drug-gene interactions provided by its IDgenetix® test significantly impacted the number of drug recommendations and contributed to improved remission rates for patients with moderate to severe depression.

Key Points: 
  • Castle Biosciences, Inc. (Nasdaq: CSTL), a company improving health through innovative tests that guide patient care, today announced data from a study showing the addition of drug-drug interactions and lifestyle factors to drug-gene interactions provided by its IDgenetix® test significantly impacted the number of drug recommendations and contributed to improved remission rates for patients with moderate to severe depression.
  • The non-genetic information (drug-drug interactions and lifestyle factors) accounted for 43% of all drug recommendations in study participants, while single-gene testing for CYP2D6 and CYP2C19 contributed to only 22%.
  • At 12 weeks, patients whose medication management was guided by IDgenetix had a remission rate of 41%, compared to only 27% of patients whose medication management was not guided by the test (p=0.03, risk ratio=1.49 [1.05-2.12]).
  • The poster can be viewed here and will also be published on HMP Global’s Psychiatry & Behavioral Health Learning Network in approximately 30-60 days.

USPTO Grants New Patent to Evoke Pharma Covering the Usage of GIMOTI® To Treat Moderate to Severe Gastroparesis

Retrieved on: 
Wednesday, December 7, 2022
NMS, Depression, Metoclopramide, Absorption, Suicidal ideation, EPS, Fatigue, Physiology, Evoke, Tardive dyskinesia, Gastroparesis, MBA, Neuroleptic malignant syndrome, Creatinine, COVID-19, Parkinsonism, Dysgeusia, Food, FDA, Patent, Risk, Internal bleeding, Perforation, Methemoglobinemia, Hypersensitivity, Extrapyramidal symptoms, Water, Moderate, Hypertension, Neoplasm, Orange Book, Bronchospasm, Epilepsy, Liver, Seizure, Patient, Kidney, United, Catecholamine, TD, Headache, Pheochromocytoma, Suicide, Stomach, Hyperprolactinaemia, History, CYP2D6, Pharmaceutical industry, Aroma compound, Residential care, Generic drug, EU
Key Points: 

    Evoke Pharma Strengthens its Intellectual Property Portfolio with a Notice of Allowance from the USPTO for a Patent Application Related to GIMOTI®

    Retrieved on: 
    Wednesday, November 30, 2022
    United, Liver, Kidney, United States Patent and Trademark Office, Risk, Bronchospasm, Creatinine, Tardive dyskinesia, Hyperprolactinaemia, Hypertension, NMS, Metoclopramide, Hypersensitivity, Dysgeusia, Patient, Suicidal ideation, Fatigue, Neoplasm, EPS, Catecholamine, TD, Seizure, Gastroparesis, FDA, Internal bleeding, COVID-19, Epilepsy, Suicide, Evoke, History, Parkinsonism, CYP2D6, Methemoglobinemia, Extrapyramidal symptoms, Vomiting, Patent, Depression, Physiology, Water, Stomach, Perforation, Headache, Neuroleptic malignant syndrome, Absorption, Pheochromocytoma, Pharmaceutical industry, Aroma compound, Residential care, Generic drug

    This patent application is a continuation of several other U.S. patent applications filed by the company over the last decade.

    Key Points: 
    • This patent application is a continuation of several other U.S. patent applications filed by the company over the last decade.
    • We are thrilled and highly encouraged by the strides we have made with the USPTO and its continued acknowledgement of the novel and inventive nature of GIMOTI, said Matt DOnofrio, Chief Business Officer of Evoke Pharma.
    • Most common adverse reactions (5%) for GIMOTI are: dysgeusia, headache, and fatigue.These are not all of the possible side effects of GIMOTI.
    • Call your doctor for medical advice about whether you should take GIMOTI and the possible risk factors and side effects.

    BioCryst Announces Approval of ORLADEYO® (berotralstat) by the Israeli Ministry of Health

    Retrieved on: 
    Monday, November 28, 2022
    Digoxin, Abdominal pain, PARK, Diarrhea, Liver, CYP3A4, Food, Ciclosporin, Ministry, CYP2D6, BioCryst Pharmaceuticals, HAE, Patient, Plasma kallikrein, Rifampicin, Back pain, Kallikrein, Disease, Vomiting, Hereditary angioedema, Gastroesophageal reflux disease, BCRP, Berotralstat, RESEARCH, Plasma, Safety, Pharmaceutical industry, Dietary supplement, Dentistry, Health, QT

    With todays announcement, we look forward to working with our partner Neopharm to launch ORLADEYO in Israel.

    Key Points: 
    • With todays announcement, we look forward to working with our partner Neopharm to launch ORLADEYO in Israel.
    • The approval of ORLADEYO is a major advancement for the HAE community in Israel.
    • The most frequently reported adverse reactions in patients receiving ORLADEYO compared with placebo were back pain and gastrointestinal reactions.
    • The gastrointestinal reactions generally occurred early after initiation of treatment with ORLADEYO, became less frequent with time and typically self-resolved.

    BioCryst Presents Real-World Data Showing Rapid and Sustained HAE Attack Rate Reduction After Beginning ORLADEYO® (berotralstat), Regardless of Prior Prophylactic Therapy

    Retrieved on: 
    Thursday, November 10, 2022
    ACAAI, GLOBE, AES, Convention, IV, Danazol, Gastroesophageal reflux disease, Plasma, Kallikrein, Internal medicine, Adult, Back pain, BioCryst Pharmaceuticals, Plasma kallikrein, Abdominal pain, Nasdaq, Hereditary angioedema, Diarrhea, Incidence, Kentucky International Convention Center, BCRP, HAE, Rifampicin, Liver, Patient, Type 2, Safety, Ciclosporin, Lanadelumab, Berotralstat, RESEARCH, Disease, PARK, CYP3A4, Poster, University, SC, CYP2D6, Food, Digoxin, Vomiting, American College, Pharmaceutical industry, Medical device, Dietary supplement, Dentistry, QT

    Every HAE patient has a unique experience with their therapy, and these data demonstrate that ORLADEYO can be a very effective treatment option for patients regardless of their reported prior attack rates or prophylactic therapy history.

    Key Points: 
    • Every HAE patient has a unique experience with their therapy, and these data demonstrate that ORLADEYO can be a very effective treatment option for patients regardless of their reported prior attack rates or prophylactic therapy history.
    • Regardless of prior prophylaxis, a rapid reduction in median attack rates was observed early (1.67 attacks/month at baseline to a median attack rate of 0.33 attacks/month in days 1-90).
    • Upon initiating ORLADEYO treatment, the reduction in median attack rates from baseline over the 1360 days period was consistent for patients regardless of their prior prophylaxis therapy.
    • Regardless of baseline attack rate, patients reported a reduction in attack rates when treated with ORLADEYO.

    Axsome Therapeutics to Ring the NASDAQ Stock Market Opening Bell Today

    Retrieved on: 
    Thursday, October 27, 2022
    Boxed warning, Nasdaq MarketSite, Narcolepsy, Company, CNS, OSA, Dopamine, MD, NASDAQ, Depression, Wakefulness, Breakthrough therapy, Food, Physician, EDS, Excessive daytime sleepiness, Food and Drug Administration, NMDA, Schedule, Dextromethorphan, Hydrogen chloride, MDD, Patient, Bupropion, Adult, Research, GLOBE, Nasdaq, Obstructive sleep apnea, Therapy, FDA, HBR, Times Square, CYP2D6, Medication, Migraine, Central nervous system, Pharmaceutical industry, Solriamfetol, COVID-19

    NEW YORK, Oct. 27, 2022 (GLOBE NEWSWIRE) -- Axsome Therapeutics, Inc. (NASDAQ: AXSM), a biopharmaceutical company developing and delivering novel therapies for the management of central nervous system (CNS) disorders, today announced that Herriot Tabuteau, MD, Axsomes Chief Executive Officer, the rest of the management team, along with other Axsome team members, will ring the opening bell of the NASDAQ Stock Market today, Thursday, October 27, 2022, to commemorate the availability of AUVELITY in the United States by prescription.

    Key Points: 
    • NEW YORK, Oct. 27, 2022 (GLOBE NEWSWIRE) -- Axsome Therapeutics, Inc. (NASDAQ: AXSM), a biopharmaceutical company developing and delivering novel therapies for the management of central nervous system (CNS) disorders, today announced that Herriot Tabuteau, MD, Axsomes Chief Executive Officer, the rest of the management team, along with other Axsome team members, will ring the opening bell of the NASDAQ Stock Market today, Thursday, October 27, 2022, to commemorate the availability of AUVELITY in the United States by prescription.
    • We are honored to ring NASDAQs opening bell to commemorate the availability of Auvelity by prescription and the hard work and dedication of the Axsome team which made it possible.
    • The ceremony will take place at the Nasdaq MarketSite, 4 Times Square, New York, NY.
    • Axsome Therapeutics, Inc. is a biopharmaceutical company developing and delivering novel therapies for central nervous system (CNS) conditions that have limited treatment options.

    BioCryst to Present New ORLADEYO® (berotralstat) Data at Annual Scientific Meeting of American College of Allergy, Asthma & Immunology

    Retrieved on: 
    Monday, October 24, 2022
    Kentucky International Convention Center, ACAAI, Liver, RESEARCH, Kallikrein, CYP3A4, Diarrhea, Patient, Poster, Rifampicin, Abdominal pain, Back pain, PARK, HAE, BioCryst Pharmaceuticals, Nasdaq, Plasma kallikrein, CYP2D6, Ciclosporin, Hereditary angioedema, Vomiting, Berotralstat, BCRP, Adult, Safety, 2021 Essex County Council election, Food, GLOBE, Plasma, American College, Gastroesophageal reflux disease, Digoxin, Pharmaceutical industry, Dentistry, QT

    The meeting will take place at the Kentucky International Convention Center in Louisville, Kentucky, from November 10-14, 2022.

    Key Points: 
    • The meeting will take place at the Kentucky International Convention Center in Louisville, Kentucky, from November 10-14, 2022.
    • Rapid and Sustained Reductions in Hereditary Angioedema Attack Rates with Long-term Berotralstat: Real-World Outcomes; Session A; Saturday, November 12, 4:30-5:30 p.m.
    • One capsule of ORLADEYO per day works to prevent HAE attacks by decreasing the activity of plasma kallikrein.
    • Additional doses or dosages of ORLADEYO higher than 150 mg once daily are not recommended due to the potential for QT prolongation.