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FDA Approved Treatment

Fabio Barra, Giovanni Grandi, Matteo Tantari, Carolina Scala, Fabio Facchinetti, Simone Ferrero
Endometriosis is a chronic benign estrogen dependent disease characterized by the presence of endometriotic glands and stroma outside the uterine cavity. Although combined hormonal contraceptives and progestins, currently available first-line treatments for endometriosis, are efficacious and well tolerated for treating disease-related pain, some women experience partial or no improvement of pain or its recurrence is frequent after discontinuation of the therapies. For these reasons, new drugs are under investigation for the treatment of endometriosis...
February 14, 2019: Expert Opinion on Biological Therapy
Andrés Pizzorno, Olivier Terrier, Claire Nicolas de Lamballerie, Thomas Julien, Blandine Padey, Aurélien Traversier, Magali Roche, Marie-Eve Hamelin, Chantal Rhéaume, Séverine Croze, Vanessa Escuret, Julien Poissy, Bruno Lina, Catherine Legras-Lachuer, Julien Textoris, Guy Boivin, Manuel Rosa-Calatrava
Influenza virus infections remain a major and recurrent public health burden. The intrinsic ever-evolving nature of this virus, the suboptimal efficacy of current influenza inactivated vaccines, as well as the emergence of resistance against a limited antiviral arsenal, highlight the critical need for novel therapeutic approaches. In this context, the aim of this study was to develop and validate an innovative strategy for drug repurposing as host-targeted inhibitors of influenza viruses and the rapid evaluation of the most promising candidates in Phase II clinical trials...
2019: Frontiers in Immunology
Karl Kunzelmann, Jiraporn Ousingsawat, Inês Cabrita, Tereza Doušová, Andrea Bähr, Melanie Janda, Rainer Schreiber, Roberta Benedetto
The inflammatory airway disease cystic fibrosis (CF) is characterized by airway obstruction due to mucus hypersecretion, airway plugging, and bronchoconstriction. The cystic fibrosis transmembrane conductance regulator (CFTR) chloride channel is dysfunctional in CF, leading to defects in epithelial transport. Although CF pathogenesis is still disputed, activation of alternative Cl- channels is assumed to improve lung function in CF. Two suitable non-CFTR Cl- channels are present in the airway epithelium, the Ca2+ activated channel TMEM16A and SLC26A9...
2019: Frontiers in Pharmacology
Charlotte C Bavley, Anjali M Rajadhyaksha
Treating cocaine addiction is a major challenge and currently no FDA approved pharmacotherapies exist. One complicating factor is a high rate of comorbidity between cocaine and neuropsychiatric conditions such as anxiety. The relationship between anxiety symptoms and cocaine addiction is complicated; anxiety can be both a predisposing factor and a consequence of cocaine use as anxiety symptoms often emerge during drug use and withdrawal. Identifying and understanding the shared biological mechanisms that lead to comorbid anxiety and cocaine addiction, irrespective of which comes first, is critical for the identification of new treatments...
February 13, 2019: Neuropsychopharmacology: Official Publication of the American College of Neuropsychopharmacology
Sebastiano Leone, Marco Cascella, Ilaria Pezone, Marco Fiore
Nowadays, the infections of patients admitted to Intensive Care Units (ICUs) are one of the major public health problems; this is due to several factors, in primis an increase in antibiotic resistance and the inappropriate use of antibiotics. This editorial focuses on both new antibiotics approved by the US Food and Drug Administration (FDA) and the European Medicines Agency (EMA) in the last decade (2010-2019), and on agents in advanced phase of development that have been developed, or are already approved, for the treatment of serious infections due to multidrug-resistant (MDR) bacteria, both Gram-positive (GPB) and Gram-negative (GNB) bacteria...
February 14, 2019: Current Medical Research and Opinion
Xiaojia Ren, Diana Boriero, Luksana Chaiswing, Subbarao Bondada, Daret K St Clair, D Allan Butterfield
Increasing numbers of cancer patients survive and live longer than five years after therapy, but very often side effects of cancer treatment arise at same time. One of the side effects, chemotherapy-induced cognitive impairment (CICI), also called "chemobrain" or "chemofog" by patients, brings enormous challenges to cancer survivors following successful chemotherapeutic treatment. Decreased abilities of learning, memory, attention, executive function and processing speed in cancer survivors with CICI, are some of the challenges that greatly impair survivors' quality of life...
February 10, 2019: Biochimica et biophysica acta. Molecular basis of disease
Chanjuan Liu, Changping Ruan, Rui Shi, Bang-Ping Jiang, Shichen Ji, Xing-Can Shen
Indocyanine green (ICG), a multifunctional near-infrared (NIR) imaging agent approved by the FDA, has been extensively used in clinical cancer theranosis, but limited by its inherent instability, short plasma half-life and lack of targeting ability. Herein, an in situ formed photothermal network based thermosensitive hydrogel (PNT-gel) constructed by using supramolecular cross-linking conjugated polymers was developed for the stabilization of ICG and efficient combinatorial photothermal/photodynamic antitumor therapy...
February 13, 2019: Biomaterials Science
T A Masterson, A Galante, M Butaney, A Pastuszak, H Sadeghi-Nejad, R Ramasamy
Collagenase clostridium histolyticum (CCH, Xiaflex, Xiapex) is the only FDA-approved medication for treatment of Peyronie's disease. It is unclear how practitioners actually use CCH in their own practices. The objectives of the study were: (1) to identify variability in practice patterns for CCH among practitioners, (2) to assess adherence to the package insert instructions, and (3) to evaluate whether provider satisfaction was associated with adherence to instructions. A 30-question online survey was distributed to 1270 members of the International Society for Sexual Medicine (ISSM) from the EU, USA, Canada and Australia...
February 12, 2019: International Journal of Impotence Research
Sataree Khuansuwan, Lisa M Barnhill, Sizhu Cheng, Jeff M Bronstein
The pathophysiology of most neurodegenerative diseases includes aberrant accumulation of protein aggregates. Recent evidence highlights the role of protein degradation pathways in neurodegeneration. Concurrently, genetic tools have been generated to enable zebrafish, Danio rerio, to be used as an animal model to study neurodegenerative processes. In addition to optical clarity and fast ex utero development, the zebrafish brain is relatively small and has conserved structures with its mammalian counterparts...
February 13, 2019: Autophagy
Swetarka Das, Tanu Garg, Sidharth Chopra, Arunava Dasgupta
Background: Non-tuberculous mycobacteria are emerging pathogens of significant worldwide interest because they have inherent drug resistance to a wide variety of FDA-approved drugs and cause a broad range of serious infections. In order to identify new drugs active against non-tuberculous mycobacteria, we identified disulfiram, utilized for treatment of alcohol dependence, as exhibiting potent growth-inhibitory activity against non-tuberculous mycobacteria. Methods: Whole-cell growth inhibition assays were used to screen and identify novel inhibitors...
February 7, 2019: Journal of Antimicrobial Chemotherapy
David J Baer, Janet A Novotny
Background: The US Food and Drug Administration (FDA) approved a qualified health claim for tree nuts and reduction of cardiovascular disease. However, cashews are excluded from that claim due to their content of saturated fats, which is predominantly stearic acid. Because stearic acid is neutral with respect to blood lipids, several studies have been conducted to test the effect of cashew nuts on blood lipids, and these studies have produced conflicting results. Objectives: The aim of this study was to conduct a highly controlled intervention to determine the effect of cashews fed at the amount specified in the health claim on risk factors for cardiovascular disease...
February 1, 2019: American Journal of Clinical Nutrition
Thomas Masterson, Premal Patel, Ranjith Ramasamy
No abstract text is available yet for this article.
February 11, 2019: International Journal of Impotence Research
Ga Won Jeon
After the first successful trial of surfactant replacement therapy for preterm infants with respiratory distress syndrome (RDS) by Fujiwara in 1980, several animal-derived natural surfactants and synthetic surfactants have been developed. Synthetic surfactants were made to overcome limitations of natural surfactants such as expensiveness, immune reactions, and infections due to animal proteins contained in natural surfactants. However, first-generation synthetic surfactants that are protein-free have failed to prove superiority over natural surfactants because they do not have surfactant protein (SP)...
February 8, 2019: Korean Journal of Pediatrics
Sheridan M Hoy
Sintilimab (Tyvyt® ) is a fully human IgG4 monoclonal antibody that binds to programmed cell death receptor-1 (PD-1), thereby blocking the interaction of PD-1 with its ligands (PD-L1 and PL-L2) and consequently helping to restore the endogenous antitumour T-cell response. It has been co-developed by Innovent Biologics and Eli Lilly and Company, and was recently approved in China for the treatment of classical Hodgkin's lymphoma in patients who have relapsed or are refractory after ≥ 2 lines of systemic chemotherapy...
February 11, 2019: Drugs
Nilutpal Sharma Bora, Bhaskar Mazumder, Santa Mandal, Yangchen D Bhutia, Sanghita Das, Sanjeev Karmakar, Pronobesh Chattopadhyay, Sanjai K Dwivedi
OBJECTIVE: Melatonin and pumpkin seed oil, along with US FDA approved UV filters were incorporated into a formulation for enhancement of UV protection by exerting an antioxidant effect. The objective of this study was to assess the protective effect of this formulation against ultraviolet (UV) radiation-induced photo dermatitis in rats, which is an established model to study the aetiopathogenic mechanisms in psoriasis vulgaris, as the former exhibits the same features to those of clinical psoriasis vulgaris in humans...
February 11, 2019: Immunopharmacology and Immunotoxicology
S A Rizza, R Bhatia, J Zeuli, Z Temesgen
Ibalizumab, a humanized monoclonal antibody to CD4, was recently approved by the United States Food and Drug Administration (FDA) for the treatment of HIV-1 infection in heavily treatment-experienced adults with multidrug-resistant HIV-1 infection failing their current antiretroviral regimen. Ibalizumab is the first in a new class of antiretroviral drugs designated as post-attachment inhibitors. It exerts its antiviral effect by noncompetitive binding of CD4, thereby blocking conformational changes in the CD4-gp120 complex that are essential for viral entry...
January 2019: Drugs of Today
Jing Jin, Wei Xiang, Shuang Wu, Min Wang, Meifang Xiao, Ali Deng
The essential roles of eukaryotic translation initiation factor 4E (eIF4E) have been shown in various cancers, including ovarian cancer. In this work, we demonstrate that eIF4E inhibition in ovarian cancer can be achieved by ribavirin, a FDA-approved antiviral drug. We show that ribavirin at clinically relevant doses significantly inhibits growth and survival in multiple ovarian cancer cell lines, regardless of morphological and molecular subtypes. Mechanistically, ribavirin suppresses Akt/mTOR and eIF4E/p70S6K signaling pathways in ovarian cancer cells...
February 7, 2019: Biochemical and Biophysical Research Communications
Hervé Bonnefoi, Camille Chakiba
In 2005, two adjuvant trials revolutionised breast cancer treatment demonstrating a 50% reduction in relapses when trastuzumab was added to adjuvant chemotherapy. In order to improve further on these results three large phase III trials were conducted. ALTTO trial evaluated lapatinib. This trial was negative and lapatinib was quite toxic. ExteNET trial evaluated neratinib in patients who already had completed adjuvant treatment with trastuzumab. Neratinib reduced the risk of relapse by 27% and the drug is FDA approved...
February 2019: Breast: Official Journal of the European Society of Mastology
Aslaa Ahmed, Gavriella Siman-Tov, Forrest Keck, Stephanie Kortchak, Allison Bakovic, Kenneth Risner, Timothy K Lu, Nishank Bhalla, Cesar de la Fuente-Nunez, Aarthi Narayanan
Venezuelan equine encephalitis virus (VEEV), a new world alphavirus belonging to the Togaviridae family, causes periodic disease outbreaks in humans and equines with high associated mortality and morbidity. VEEV is highly infectious via the aerosol route and so has been developed as a biological weapon (Hawley and Eitzen, 2001). Despite its current classification as a category B select agent, there are no FDA approved vaccines or therapeutics to counter VEEV infections. Here we utilize a naturally occurring host defense peptide, LL-37, as a therapeutic strategy to inhibit VEEV multiplication in infected cells...
February 7, 2019: Antiviral Research
Andrew E Mulberg, Christina Bucci-Rechtweg, Joseph Giuliano, David Jacoby, Franklin K Johnson, Qing Liu, Deborah Marsden, Scott McGoohan, Robert Nelson, Nita Patel, Klaus Romero, Vikram Sinha, Sheela Sitaraman, John Spaltro, Vivian Kessler
Rare or orphan diseases often are inherited and overwhelmingly affect children. Many of these diseases have no treatments, are incurable, and have a devastating impact on patients and their families. Regulatory standards for drug approval for rare diseases must ensure that patients receive safe and efficacious treatments. However, regulatory bodies have shown flexibility in applying these standards to drug development in rare diseases, given the unique challenges that hinder efficient and effective traditional clinical trials, including low patient numbers, limited understanding of disease pathology and progression, variability in disease presentation, and a lack of established endpoints...
February 8, 2019: Orphanet Journal of Rare Diseases
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