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Drugs in R&D

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https://www.readbyqxmd.com/read/29992490/evaluation-of-cardiovascular-disease-risk-in-hiv-1-infected-patients-treated-with-darunavir
#1
Magda Opsomer, Dessislava Dimitrova, Johan Verspeelt, Amy Purrington, Abdul Mehbob, Scott Chavers, Helen Pai, Simon Vanveggel, Donghan Luo, Kimberley Brown, Christiane Moecklinghoff, Richard E Nettles, Katia Boven
INTRODUCTION: We evaluated cardiovascular disease (CVD) risk associated with darunavir treatment and examined the demographic/clinical characteristics of darunavir users based on data from Janssen-sponsored clinical trials, post-marketing pharmacovigilance databases, and administrative claims databases. METHODS: First, selected CVD events [myocardial infarction, stroke, sudden death, invasive cardiovascular procedures (coronary artery angioplasty or bypass, or carotid endarterectomy)] were analyzed in 19 Janssen-sponsored phase 2-4 studies (incidence rates estimated from pooled data; 95% confidence intervals derived from Poisson distribution)...
July 10, 2018: Drugs in R&D
https://www.readbyqxmd.com/read/29987670/correction-to-efficacy-and-safety-of-sublingual-fentanyl-tablets-in-breakthrough-cancer-pain-management-according-to-cancer-stage-and-background-opioid-medication
#2
Jordi Guitart, María Isabel Vargas, Vicente De Sanctis, Jordi Folch, Rafael Salazar, José Fuentes, Joan Coma, Julia Ferreras, Jordi Moya, Albert Tomás, Pere Estivill, Francisco Rodelas, Antonio Javier Jiménez, Almudena Sanz
In the Original Publication.
July 9, 2018: Drugs in R&D
https://www.readbyqxmd.com/read/29948779/octreotide-use-in-neonates-a-case-series
#3
Syed Ahmed Zaki, Mohan B Krishnamurthy, Atul Malhotra
BACKGROUND AND OBJECTIVE: Octreotide is a somatostatin analogue and has been used off-label for a variety of conditions. There are no specific guidelines for the use of octreotide in neonates and its safety and efficacy have not been systematically evaluated. The objective of this study is to present our experience of using octreotide therapy in neonates. METHODS: This is a retrospective study of neonates who received octreotide therapy during their hospital stay over a 15 years period (2003-2017) in a tertiary neonatal centre...
June 15, 2018: Drugs in R&D
https://www.readbyqxmd.com/read/29856004/pharmacokinetics-of-the-oral-selective-cxcr2-antagonist-azd5069-a-summary-of-eight-phase-i-studies-in-healthy-volunteers
#4
Marie Cullberg, Cecilia Arfvidsson, Bengt Larsson, Anna Malmgren, Patrick Mitchell, Ulrika Wählby Hamrén, Heather Wray
OBJECTIVE: The aim of this study was to summarise the pharmacokinetic findings from eight phase I studies in healthy volunteers given oral AZD5069, a selective small-molecule CXCR2 antagonist. METHODS: 240 healthy volunteers across eight phase I studies received single (0.1-200 mg) or multiple once- or twice-daily (10-120 mg) oral AZD5069 as solution, suspension, capsules or tablets. Pharmacokinetics were evaluated using non-compartmental analysis methods. RESULTS: AZD5069 was rapidly absorbed (time to maximum concentration ~ 2 h) under fasting conditions...
June 2018: Drugs in R&D
https://www.readbyqxmd.com/read/29808389/correction-to-feasibility-safety-and-efficacy-of-an-alternative-schedule-of-sunitinib-for-the-treatment-of-patients-with-metastatic-renal-cell-carcinoma-a-retrospective-study
#5
Sebastiano Buti, Maddalena Donini, Melissa Bersanelli, Alessia Gattara, Francesco Leonardi, Rodolfo Passalacqua
In the Original Publication of the article, In Introduction part, 7th line, the value "5-100nM" has been published incorrectly. The correct value should read as "Plasma concentration of 50-100ng/ml". In the Original Publication of the article, page 591, Table 2 has been published incorrectly. The corrected table is shown in the following page.
June 2018: Drugs in R&D
https://www.readbyqxmd.com/read/29799099/co-crystal-of-tramadol-celecoxib-in-patients-with-moderate-to-severe-acute-post-surgical-oral-pain-a-dose-finding-randomised-double-blind-placebo-and-active-controlled-multicentre-phase-ii-trial
#6
José López-Cedrún, Sebastián Videla, Miguel Burgueño, Inma Juárez, Samir Aboul-Hosn, Rafael Martín-Granizo, Joan Grau, Miguel Puche, José-Luis Gil-Diez, José-Antonio Hueto, Anna Vaqué, Mariano Sust, Carlos Plata-Salamán, Antoni Monner
BACKGROUND: Co-crystal of tramadol-celecoxib (CTC), containing equimolar quantities of the active pharmaceutical ingredients (APIs) tramadol and celecoxib (100 mg CTC = 44 mg rac-tramadol hydrochloride and 56 mg celecoxib), is a novel API-API co-crystal for the treatment of pain. We aimed to establish the effective dose of CTC for treating acute pain following oral surgery. METHODS: A dose-finding, double-blind, randomised, placebo- and active-controlled, multicentre (nine Spanish hospitals), phase II study (EudraCT number: 2011-002778-21) was performed in male and female patients aged ≥ 18 years experiencing moderate to severe pain following extraction of two or more impacted third molars requiring bone removal...
June 2018: Drugs in R&D
https://www.readbyqxmd.com/read/29737467/correction-to-the-many-faces-of-apomorphine-lessons-from-the-past-and-challenges-for-the-future
#7
Manon Auffret, Sophie Drapier, Marc Vérin
In the original publication, the name of the author in T.
June 2018: Drugs in R&D
https://www.readbyqxmd.com/read/29671128/a-phase-i-study-of-the-pharmacokinetics-and-pharmacodynamics-of-intranasal-doxylamine-in-subjects-with-chronic-intermittent-sleep-impairment
#8
Mark Allison, Cecilia Hale
INTRODUCTION: Doxylamine tablets are approved as an over-the-counter sleep aid. We developed a doxylamine succinate intranasal metered-dose delivery system with the expectation of a more rapid onset of action with reduced side-effect potential compared with the oral tablet. METHODS: This phase I study randomized 24 adults with chronic intermittent sleep impairment to receive either single doses of intranasal doxylamine succinate 3.2, 6.3, or 12.7 mg or doxylamine succinate 25-mg oral tablet...
June 2018: Drugs in R&D
https://www.readbyqxmd.com/read/29572732/efficacy-and-safety-of-sublingual-fentanyl-tablets-in-breakthrough-cancer-pain-management-according-to-cancer-stage-and-background-opioid-medication
#9
Jordi Guitart, María Isabel Vargas, Vicente De Sanctis, Jordi Folch, Rafael Salazar, José Fuentes, Joan Coma, Julia Ferreras, Jordi Moya, Albert Tomás, Pere Estivill, Francisco Rodelas, Antonio Javier Jiménez, Almudena Sanz
OBJECTIVE: Our objective was to assess the effect of sublingual fentanyl tablets (SFTs) on pain relief, quality of life, and adverse effects in patients with cancer pain, according to cancer stage and background opioid regimen. METHODS: Subgroup analyses from a recently completed study were performed according to cancer stage (locally advanced cancer [LAC] vs. metastatic cancer) and most frequent background opioid medication (fentanyl vs. oxycodone/naloxone). The efficacy and safety of SFTs were evaluated, recording pain intensity (PI), onset of pain relief, and adverse events (AEs)...
June 2018: Drugs in R&D
https://www.readbyqxmd.com/read/29546602/the-many-faces-of-apomorphine-lessons-from-the-past-and-challenges-for-the-future
#10
REVIEW
Manon Auffret, Sophie Drapier, Marc Vérin
Apomorphine is now recognized as the oldest antiparkinsonian drug on the market. Though still underused, it is increasingly prescribed in Europe for patients with advanced Parkinson's disease (PD) with motor fluctuations. However, its history is far from being limited to movement disorders. This paper traces the history of apomorphine, from its earliest empirical use, to its synthesis, pharmacological development, and numerous indications in human and veterinary medicine, in light of its most recent uses and newest challenges...
June 2018: Drugs in R&D
https://www.readbyqxmd.com/read/29488154/evaluation-of-the-pharmacokinetics-and-safety-of-a-single-oral-dose-of-fasiglifam-in-subjects-with-mild-or-moderate-hepatic-impairment
#11
John Marcinak, Majid Vakilynejad, Akifumi Kogame, Yoshihiko Tagawa
BACKGROUND AND AIMS: Fasiglifam, a potent, selective novel agonist of G protein-coupled receptor 40, stimulates insulin secretion at elevated blood glucose levels in a glucose-dependent manner. This study evaluated the potential effect of hepatic impairment on the pharmacokinetics and safety of a single dose of fasiglifam and its metabolite M-I. Fasiglifam's clinical development was halted due to liver safety concerns. METHODS: In this phase I, open-label study, subjects with mild or moderate hepatic impairment, along with matched controls (gender, weight, age, and smoking status), received a single, 25-mg oral dose of fasiglifam...
June 2018: Drugs in R&D
https://www.readbyqxmd.com/read/29468559/15-years-of-experience-with-biphasic-insulin-aspart-30-in-type-2-diabetes
#12
REVIEW
Andreas Liebl, Viswanathan Mohan, Wenying Yang, Krzysztof Strojek, Sultan Linjawi
Since clinical experience with biphasic insulin aspart 30 (BIAsp 30) in type 2 diabetes mellitus (T2DM) was reviewed in 2012 after 10 years of use worldwide, additional studies have been published that highlight new aspects, including use in real-world populations. Evidence from 35 new studies confirms and builds upon previous work indicating that BIAsp 30 continues to have pharmacodynamic and clinical advantages over biphasic human insulin (BHI 30), including in real-world practice with unselected populations of patients...
March 2018: Drugs in R&D
https://www.readbyqxmd.com/read/29404858/bayesian-networks-a-new-approach-to-predict-therapeutic-range-achievement-of-initial-cyclosporine-blood-concentration-after-pediatric-hematopoietic-stem-cell-transplantation
#13
Vincent Leclerc, Michel Ducher, Nathalie Bleyzac
BACKGROUND: Pediatric hematopoietic stem cell transplantation (HSCT) allows the treatment of numerous diseases, both malignant and non-malignant. Cyclosporine, a narrow therapeutic index drug, is the major immunosuppressant used to prevent graft-versus-host disease (GVHD), but may also cause severe adverse effects in case of overdosing. OBJECTIVE: The objective of this study is to predict the initial cyclosporine residual blood concentration value after pediatric HSCT, and consequently the dose necessary to reach the therapeutic range, using a mathematical individual predictive model...
March 2018: Drugs in R&D
https://www.readbyqxmd.com/read/29392574/comparison-of-the-pharmacokinetics-of-droxidopa-after-dosing-in-the-fed-versus-fasted-state-and-with-3-times-daily-dosing-in-healthy-elderly-subjects
#14
Jack J Chen, L Arthur Hewitt
BACKGROUND: Droxidopa is an oral prodrug of norepinephrine approved for the treatment of symptomatic neurogenic orthostatic hypotension. This two-part, randomized, crossover study evaluated the 24-h pharmacokinetic profile of droxidopa in 24 healthy elderly subjects. METHODS: Noncompartmental analysis was used to calculate the area under the plasma concentration-time curve (AUC), maximum plasma concentration (Cmax ), time of Cmax (tmax ), and elimination half-life (t½e ) of droxidopa and metabolites...
March 2018: Drugs in R&D
https://www.readbyqxmd.com/read/29374829/in-vitro-safety-pharmacology-profiling-of-topical-%C3%AE-adrenergic-agonist-treatments-for-erythema-of-rosacea
#15
David Piwnica, Atul Pathak, Gregor Schäfer, James R Docherty
BACKGROUND: Topical α-adrenergic agonist therapy has been developed to treat the persistent erythema of rosacea patients. Brimonidine and oxymetazoline are both topical α-adrenergic agonists. OBJECTIVES: The objective of this in vitro safety pharmacology study was to compare the potential safety profiles of brimonidine and oxymetazoline. METHODS: Brimonidine and oxymetazoline underwent pharmacological profiling with a standard panel of 151 assays, including α-adrenergic receptors and 5-hydroxytryptamine (5-HT) receptors...
March 2018: Drugs in R&D
https://www.readbyqxmd.com/read/29330776/second-hand-exposure-of-staff-administering-vaporised-cannabinoid-products-to-patients-in-a-hospital-setting
#16
Nadia Solowij, Peter Galettis, Samantha J Broyd, Peter de Krey, Jennifer H Martin
BACKGROUND: In many health settings, administration of medicinal cannabis poses significant implementation barriers including drug storage and safety for administering staff and surrounding patients. Different modes of administration also provide different yet potentially significant issues. One route that has become of clinical interest owing to the rapid onset of action and patient control of the inhaled amount (via breath timing and depth) is that of vaporisation of cannabinoid products...
March 2018: Drugs in R&D
https://www.readbyqxmd.com/read/29260458/the-risk-of-thrombocytopenia-during-valproic-acid-therapy-a-critical-summary-of-available-clinical-data
#17
Massimiliano Buoli, Marta Serati, Andrea Botturi, A Carlo Altamura
Valproate is an effective anti-epileptic and mood stabilizer drug, but its prescription may be complicated by the development of thrombocytopenia. The purpose of the present manuscript is to provide a critical overview about the risk of thrombocytopenia during treatment with valproate. A search of the main database sources has been conducted to identify relevant papers about the topic. In the studies with a larger sample size (> 150 subjects), thrombocytopenia occurred in 12-18% of subjects receiving treatment with valproate...
March 2018: Drugs in R&D
https://www.readbyqxmd.com/read/29255971/effects-of-a-fixed-dose-co-formulation-of-daclatasvir-asunaprevir-and-beclabuvir-on-the-pharmacokinetics-of-a-cocktail-of-cytochrome-p450-and-drug-transporter-substrates-in-healthy-subjects
#18
Tushar Garimella, Xiaolu Tao, Karen Sims, Yi-Ting Chang, Jignasa Rana, Elsa Myers, Megan Wind-Rotolo, Rahul Bhatnagar, Timothy Eley, Frank LaCreta, Malaz AbuTarif
BACKGROUND: A fixed-dose combination of daclatasvir (DCV; hepatitis C virus NS5A inhibitor), asunaprevir (ASV; non-structural protein 3 inhibitor), and beclabuvir (BCV; non-structural protein 5B inhibitor) is approved in Japan for hepatitis C virus genotype 1. OBJECTIVE: The objective of this study was to assess the combination's drug-drug interaction potential in vivo using a validated cocktail of eight cytochrome P450 (CYP) and transporter probes. METHODS: We conducted an open-label single-sequence study in healthy adults (n = 20) given single-dose caffeine (CYP1A2 substrate), metoprolol (CYP2D6), flurbiprofen (CYP2C9), montelukast (CYP2C8), omeprazole (CYP2C19), midazolam (CYP3A4), digoxin (P-glycoprotein), and pravastatin (organic anion-transporting polypeptide), alone or with steady-state twice-daily DCV/ASV/BCV 30/200/75 mg (with or without additional BCV 75 mg to adjust for higher exposure in hepatitis C virus infection)...
March 2018: Drugs in R&D
https://www.readbyqxmd.com/read/29214385/sealing-effects-on-the-storage-stability-of-the-cyanide-antidotal-candidate-dimethyl-trisulfide
#19
Lóránd Kiss, Anna Duke, Kristof Kovacs, Tibor Barcza, Márton Kiss, Ilona Petrikovics, David E Thompson
BACKGROUND: Dimethyl trisulfide (DMTS) is a highly lipid-soluble cyanide (CN) antidote candidate molecule. In prior studies with various US FDA-approved co-solvents, surfactants, and their combinations, aqueous solutions containing 15% polysorbate 80 (Poly80) were found to effectively solubilize DMTS in formulations for intramuscular administration. However, DMTS formulated in 15% aqueous Poly80 solutions showed gradual losses over time when stored in vials with septum-based seals. OBJECTIVE: The present study tested whether storing DMTS formulations in hermetically sealed glass ampules could mitigate storage losses...
March 2018: Drugs in R&D
https://www.readbyqxmd.com/read/29209910/efficacy-and-safety-of-nintedanib-for-the-treatment-of-idiopathic-pulmonary-fibrosis-an-update
#20
José Antonio Rodríguez-Portal
Idiopathic pulmonary fibrosis is a fatal form of progressive fibrosing interstitial pneumonia with limited treatment options. In recent years, its management has been transformed with the approval of two new antifibrotic drugs: nintedanib and pirfenidone. Nintedanib is a tyrosine kinase inhibitor that efficiently slows idiopathic pulmonary fibrosis progression and has an acceptable tolerability profile. This article reviews new available evidence on the long-term efficacy and safety of nintedanib in patients with idiopathic pulmonary fibrosis...
March 2018: Drugs in R&D
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