In Vitro Investigation of Auranofin as a Treatment for Clostridium difficile Infection
ConclusionsAuranofin is highly efficacious againstC. difficile M7404 in vitro and has the potential to be an ideal therapeutic option for the treatment ofC. difficile infection. (Source: Drugs in R&D)
Source: Drugs in R&D - May 5, 2020 Category: Drugs & Pharmacology Source Type: research

Public Health Outcomes May Differ After Switching from Brand-Name to Generic Angiotensin II Receptor Blockers
ConclusionsWe observed an increased risk of hospitalizations for patients switched to generic valsartan, and a decreased risk of death for patients switched to generic candesartan, compared with those who continued taking the brand-name drug. The differences between generic and brand-name drugs may lead to some differences in public health outcomes, but this safety signal must be further studied using other cohorts and settings. (Source: Drugs in R&D)
Source: Drugs in R&D - April 26, 2020 Category: Drugs & Pharmacology Source Type: research

Frequency and Types of Pathological Upper Gastrointestinal Endoscopy Findings in Clinically Healthy Individuals
ConclusionUpper gastrointestinal tract mucosal lesions, including those assessed as clinically relevant, are frequent in clinically healthy individuals, impeding the assessment of causality for both disease and drug effects on gastrointestinal health. (Source: Drugs in R&D)
Source: Drugs in R&D - April 24, 2020 Category: Drugs & Pharmacology Source Type: research

An Ex Vivo Evaluation of Cenobamate Administered via Enteral Tubes
ConclusionThe mean % LC recovery of cenobamate was within the predetermined acceptable range of 90.0 –110.0%, suggesting no adhesion or adsorption of cenobamate to enteral feeding tubes. Delivery of cenobamate suspension via enteral feeding tubes may be a viable route of administration for patients who cannot swallow tablets. (Source: Drugs in R&D)
Source: Drugs in R&D - April 22, 2020 Category: Drugs & Pharmacology Source Type: research

Combining Isotopic Tracer Techniques to Increase Efficiency of Clinical Pharmacokinetic Trials in Oncology
AbstractWith increasing numbers of drugs tested in oncology for smaller patient populations, fewer patients are available to answer important clinical pharmacological questions in the timeframe of clinical drug development. The quality and efficiency of trials to assess the pharmacokinetics of new drugs can be improved by making better use of available resources. One approach to do this is by making more effective use of isotopic tracer techniques. With increasing sensitivity of liquid chromatography-tandem mass spectrometry analyzing equipment over the years, it has now become possible to generate much more rich, high-qua...
Source: Drugs in R&D - April 15, 2020 Category: Drugs & Pharmacology Source Type: research

Assessment of Vancomycin Pharmacokinetics and Dose Regimen Optimisation in Preterm Neonates
ConclusionThe majority of the neonates were under dosed. Vancomycin 12  mg/kg should be administered every 8 h over 1 h infusion to improve the likelihood of achieving the AUC0 –24h target of ≥ 400 mg × h/L. This target is considered optimal for MRSA infections, where the vancomycin minimum inhibitory concentration is ≤ 1 µg/mL. (Source: Drugs in R&D)
Source: Drugs in R&D - April 7, 2020 Category: Drugs & Pharmacology Source Type: research

Efficacy and Safety of VB-1953 Topical Gel in Non-Responder Acne Patients with Clindamycin-Resistant Cutibacterium acnes
ConclusionThese results indicate that VB-1953 topical gel can be a safe and effective therapy for moderate to severe acne with underlying resistantC. acnes in subjects who had not responded to previous antibiotic treatments. (Source: Drugs in R&D)
Source: Drugs in R&D - March 27, 2020 Category: Drugs & Pharmacology Source Type: research

Poly (ADP-Ribose) Polymerase Inhibitors: Talazoparib in Ovarian Cancer and Beyond
AbstractGenetic complexity and DNA damage repair defects are common in different cancer types and can induce tumor-specific vulnerabilities. Poly(ADP-ribose) polymerase (PARP) inhibitors exploit defects in the DNA repair pathway through synthetic lethality and have emerged as promising anticancer therapies, especially in tumors harboring deleterious germline or somatic breast cancer susceptibility gene (BRCA) mutations. However, the utility of PARP inhibitors could be expanded beyond germlineBRCA1/2 mutated cancers by causing DNA damage with cytotoxic agents in the presence of a DNA repair inhibitor. US Food and Drug Admin...
Source: Drugs in R&D - March 24, 2020 Category: Drugs & Pharmacology Source Type: research

Dolutegravir-Based Antiretroviral Regimens for HIV Liver Transplant Patients in Real-Life Settings
ConclusionsThe management of HIV-positive liver transplant recipients in clinical practice is a complex task, where possibility of simplifying antiretroviral regimens must be balanced with the need to guarantee optimal immunosuppression and the finest treatment tolerability. A multidisciplinary approach involving physicians and clinical pharmacologists/pharmacists could help achieve this goal. (Source: Drugs in R&D)
Source: Drugs in R&D - March 17, 2020 Category: Drugs & Pharmacology Source Type: research

Concordance of Vancomycin Population-Predicted Pharmacokinetics with Patient-Specific Pharmacokinetics in Adult Hospitalized Patients: A Case Series
ConclusionsIn this case series, population-predicted pharmacokinetic parameters were strongly correlated with patient-specific pharmacokinetic parameters. The vancomycin population-predicted pharmacokinetic formula can be used safely to predict a patient ’s vancomycin pharmacokinetic disposition and can be maintained as an empiric dosing strategy in various hospitalized adult patients. (Source: Drugs in R&D)
Source: Drugs in R&D - March 11, 2020 Category: Drugs & Pharmacology Source Type: research

Plasma Polyethylene Glycol (PEG) Levels Reach Steady State Following Repeated Treatment with N8-GP (Turoctocog Alfa Pegol; Esperoct ® )
ConclusionSteady-state PEG levels were reached in plasma from rats and humans repeatedly treated with N8-GP. No unexpected increase in PEG was observed. (Source: Drugs in R&D)
Source: Drugs in R&D - March 8, 2020 Category: Drugs & Pharmacology Source Type: research

Phase I Pharmacokinetic Study of Fixed-Dose Combinations of Ibuprofen and Acetaminophen in Healthy Adult and Adolescent Populations
ConclusionsThe FDC of ibuprofen/acetaminophen 250/500  mg has a PK profile similar to its monocomponent constituents when administered separately or coadministered, indicating no drug–drug interactions and no formulation effects. Similar to previous findings for the individual components, the rates of absorption of ibuprofen and acetaminophen from t he FDC were slightly delayed in the presence of food. Overall, adolescents had similar exposures to acetaminophen and ibuprofen as adults, while younger adolescents had slightly greater exposure than older adolescents, probably due to their smaller body size. The FDC was gen...
Source: Drugs in R&D - March 3, 2020 Category: Drugs & Pharmacology Source Type: research

Intramuscular Clodronate in Long-Term Treatment of Symptomatic Knee Osteoarthritis: A Randomized Controlled Study
ConclusionOur study indicates that intramuscular administration of a therapeutic dose of clodronate followed by a maintenance dose is effective in the management of symptomatic knee osteoarthritis, improving functional outcomes and reducing pain and bone marrow edema. Prolonged treatment increases the long-term efficacy of clodronate compared with the shorter schedule. (Source: Drugs in R&D)
Source: Drugs in R&D - February 19, 2020 Category: Drugs & Pharmacology Source Type: research

Double-Blind Placebo-Controlled Pilot Investigation of the Safety of a Single Dose of Rapid-Acting Intranasal Insulin in Down Syndrome
ConclusionsFurther investigations are necessary to better evaluate the potential cognitive-enhancing role of intranasal insulin in the Down syndrome population.ClinicalTrials.gov IDNCT02432716. (Source: Drugs in R&D)
Source: Drugs in R&D - February 18, 2020 Category: Drugs & Pharmacology Source Type: research

Prediction of Clearance in Children from Adults Following Drug –Drug Interaction Studies: Application of Age-Dependent Exponent Model
ConclusionThis study indicates that it is possible to predict the clearance of drugs with reasonable accuracy in children from adults following DDI studies using an ADE model. The method is simple, robust, and reliable and can replace other complex empirical models. (Source: Drugs in R&D)
Source: Drugs in R&D - February 12, 2020 Category: Drugs & Pharmacology Source Type: research