Sealing Effects on the Storage Stability of the Cyanide Antidotal Candidate, Dimethyl Trisulfide
ConclusionDMTS formulated in 15% aqueous Poly80 solution has excellent stability when stored in fire-sealed glass ampules and thus has the potential to be effectively stored as an intramuscular CN countermeasure for mass casualty scenarios. (Source: Drugs in R&D)
Source: Drugs in R&D - December 6, 2017 Category: Drugs & Pharmacology Source Type: research

Efficacy and Safety of Nintedanib for the Treatment of Idiopathic Pulmonary Fibrosis: An Update
This article reviews new available evidence on the long-term efficacy and safety of nintedanib in patients with idiopathic pulmonary fibrosis. Data from extension trials indicate that nintedanib continues to slow disease progression for up to 3  years and is similarly effective in patients with mild and severe impairment of lung function. Treatment with nintedanib reduces the risk of acute exacerbations, and a combined analysis of data from clinical trials of nintedanib shows a trend towards a reduction in mortality. Nintedanib is well to lerated and has been shown to be safe for up to 51 months. Gastrointestinal events,...
Source: Drugs in R&D - December 5, 2017 Category: Drugs & Pharmacology Source Type: research

Intranasal Therapy to Stop Status Epilepticus in Prehospital Settings
AbstractStatus epilepticus (SE) is a medical emergency characterized by uncontrolled, prolonged seizures with rapid and widespread neuronal damage. Patients that suffer from longer episodes of SE are more likely to have poorer clinical outcomes and a higher cost of healthcare. Understanding novel molecular mechanisms that regulate inhibitory and excitatory neurotransmission that initiate SE and the necessary medical infrastructure to stop SE could help identify targets for early intervention. Intranasal administration of benzodiazepines may shorten the time between initiation and cessation of seizures when compared to othe...
Source: Drugs in R&D - November 25, 2017 Category: Drugs & Pharmacology Source Type: research

Bioavailability of Orally Administered Des-Aspartate-Angiotensin I in Human Subjects
AbstractIn an earlier single-dose escalation study to evaluate the safety and pharmacokinetics of orally administered des-aspartate-angiotensin I (DAA-I) in healthy subjects, the plasma level of DAA-I could not be determined because DAA-I is rapidly degraded in the circulation. The present study investigated the oral bioavailability of DAA-I by measuring the prostaglandin E2 metabolite (PGEM) in the plasma samples of the same trial. PGEM is a stable derivative of PGE2, which has been shown to be a biomarker of DAA-I. The data show that plasma from two of the three subjects who were orally administered the efficacious precl...
Source: Drugs in R&D - November 22, 2017 Category: Drugs & Pharmacology Source Type: research

Acknowledgement to Referees
(Source: Drugs in R&D)
Source: Drugs in R&D - November 15, 2017 Category: Drugs & Pharmacology Source Type: research

A Randomized Multiple Dose Pharmacokinetic Study of a Novel PDE10A Inhibitor TAK-063 in Subjects with Stable Schizophrenia and Japanese Subjects and Modeling of Exposure Relationships to Adverse Events
ConclusionsMultiple doses of TAK-063 were safe and well tolerated. PK/AE models characterized the incidence of somnolence and EPS with increasing TAK-063 exposure, and simulations suggested that a once-daily dose range of up to 30  mg would be suitable for future studies.ClinicalTrials.gov IdentifierNCT01879722. (Source: Drugs in R&D)
Source: Drugs in R&D - November 4, 2017 Category: Drugs & Pharmacology Source Type: research

The Adherence Rate Threshold is Drug Specific
ConclusionThese results indicate that a value of 0.8 cannot be applied universally. (Source: Drugs in R&D)
Source: Drugs in R&D - October 26, 2017 Category: Drugs & Pharmacology Source Type: research

Serious Adverse Events Among SPRINT Trial Participants Taking Statins at Baseline
ConclusionsIn SPRINT, generally statin use was not associated with increased risk of reporting SAEs. Only statin use by higher risk patients was associated with more overall SAEs. Confounding by clinical CVD and the polytherapy of intensive BP management may explain this. (Source: Drugs in R&D)
Source: Drugs in R&D - October 22, 2017 Category: Drugs & Pharmacology Source Type: research

Transmucosal Delivery of Nicotine in Combination with Tincture of Benzoin Inhibits Apoptosis
ConclusionTwo hours of TOB (17 –24% benzoin, 79% ETOH) plus nicotine promotes diffusion of nicotine across human mucosal cells and simultaneously prevents human mucosal cell toxicity by inhibiting cytochromec release into the cytosol, thereby preventing caspase 3 and 9 activity and subsequent intrinsic apoptosis. (Source: Drugs in R&D)
Source: Drugs in R&D - October 20, 2017 Category: Drugs & Pharmacology Source Type: research

Switching Between Biological Treatments in Psoriatic Arthritis: A Review of the Evidence
AbstractPsoriatic arthritis (PsA) is a chronic inflammatory arthropathy. Therapy with anti-tumor necrosis factor (TNF)- α agents represents the first therapeutic choice for moderate and severe forms; however, PsA patients can experience anti-TNFα failure, lack of efficacy, or adverse events. Several evidences exist on the effectiveness of switching among different TNFα inhibitors, and we reviewed the published dat a on the effectiveness of anti-TNFα first-, second- and third-line. Most of the studies report that the main reason for switching to a second anti-TNFα agent is represented by lack of efficacy (primary or se...
Source: Drugs in R&D - October 20, 2017 Category: Drugs & Pharmacology Source Type: research

Identification of Polymorphic Forms of Active Pharmaceutical Ingredient in Low-Concentration Dry Powder Formulations by Synchrotron X-Ray Powder Diffraction
ConclusionFour different polymorphic forms of tiotropium bromide present at 0.4  w/w% concentration in lactose powder blends were unambiguously identified by the synchrotron XRPD method. (Source: Drugs in R&D)
Source: Drugs in R&D - September 13, 2017 Category: Drugs & Pharmacology Source Type: research

Pharmacokinetics of a New Oral Vitamin D Receptor Activator (2-Methylene-19-Nor-(20S)-1 α,25-Dihydroxyvitamin D 3 ) in Patients with Chronic Kidney Disease and Secondary Hyperparathyroidism on Hemodialysis
ConclusionsIn hemodialysis patients, DP001 has a longer half-life than existing vitamin D therapies and enables control of parathyroid hormone when administered every 2 –3 days on the day of dialysis. It is effective at a lower concentration maximum and area under the curve than other clinically available vitamin D compounds. DP001 may represent a therapeutic improvement over existing compounds due to rapid and extensive distribution to its target and its long h alf-life enabling sustained parathyroid hormone suppression. These studies support further evaluation of DP001 in longer-term treatment of secondary hyperparath...
Source: Drugs in R&D - September 13, 2017 Category: Drugs & Pharmacology Source Type: research

Feasibility, Safety, and Efficacy of an Alternative Schedule of Sunitinib for the Treatment of Patients with Metastatic Renal Cell Carcinoma: A Retrospective Study
ConclusionsDespite the small sample size and retrospective nature, we demonstrated the feasibility, safety, and efficacy of the alternative schedule, allowing prolonged treatment and better quality of life. (Source: Drugs in R&D)
Source: Drugs in R&D - September 11, 2017 Category: Drugs & Pharmacology Source Type: research

Adverse Event Profile of Pyrimethamine-Based Therapy in Toxoplasmosis: A Systematic Review
ConclusionThe AE profile associated with pyrimethamine-based treatments differed by each manifestation of toxoplasmosis and within a given manifestation. Hematologic AEs occurred across all manifestations indicating the importance of monitoring the blood of patients administered pyrimethamine-based regimens. (Source: Drugs in R&D)
Source: Drugs in R&D - September 6, 2017 Category: Drugs & Pharmacology Source Type: research

Pharmacokinetic Effects of Antidrug Antibodies Occurring in Healthy Subjects After a Single Dose of Intravenous Infliximab
ConclusionADAs are common in healthy subjects after a single intravenous dose of infliximab and result in faster infliximab clearance, shorter elimination time, and lower serum infliximab levels. These data confirm that ADAs are common with biologic therapy and significantly impact the efficacy of these drugs. (Source: Drugs in R&D)
Source: Drugs in R&D - September 6, 2017 Category: Drugs & Pharmacology Source Type: research