DOCSLIB.ORG

AHRQ Healthcare Horizon Scanning System – Status Update Horizon

Total Page：16

File Type：pdf, Size：1020Kb

Download full-text PDF Read full-text
AHRQ Healthcare Horizon Scanning System – Status Update Horizon AHRQ Healthcare Horizon Scanning System – Status Update Horizon Scanning Status Update: April 2015 Prepared for: Agency for Healthcare Research and Quality U.S. Department of Health and Human Services 540 Gaither Road Rockville, MD 20850 www.ahrq.gov Contract No. HHSA290-2010-00006-C Prepared by: ECRI Institute 5200 Butler Pike Plymouth Meeting, PA 19462 April 2015 Statement of Funding and Purpose This report incorporates data collected during implementation of the Agency for Healthcare Research and Quality (AHRQ) Healthcare Horizon Scanning System by ECRI Institute under contract to AHRQ, Rockville, MD (Contract No. HHSA290-2010-00006-C). The findings and conclusions in this document are those of the authors, who are responsible for its content, and do not necessarily represent the views of AHRQ. No statement in this report should be construed as an official position of AHRQ or of the U.S. Department of Health and Human Services. A novel intervention may not appear in this report simply because the System has not yet detected it. The list of novel interventions in the Horizon Scanning Status Update Report will change over time as new information is collected. This should not be construed as either endorsements or rejections of specific interventions. As topics are entered into the System, individual target technology reports are developed for those that appear to be closer to diffusion into practice in the United States. A representative from AHRQ served as a Contracting Officer’s Technical Representative and provided input during the implementation of the horizon scanning system. AHRQ did not directly participate in the horizon scanning, assessing the leads or topics, or provide opinions regarding potential impact of interventions. Disclaimer Regarding 508-Compliance Persons using assistive technology may not be able to fully access information in this report. For assistance contact [email protected]. Financial Disclosure Statement None of the individuals compiling this information has any affiliations or financial involvement that conflicts with the material presented in this report. Public Domain Notice This document is in the public domain and may be used and reprinted without special permission. Citation of the source is appreciated. Suggested citation: ECRI Institute. AHRQ Healthcare Horizon Scanning System Status Update. (Prepared by ECRI Institute under Contract No. HHSA290-2010-00006-C) Rockville, MD: Agency for Healthcare Research and Quality. April 2015. http://www.effectivehealthcare.ahrq.gov/reports/final.cfm. i Preface The purpose of the AHRQ Healthcare Horizon Scanning System is to conduct horizon scanning of emerging health care technologies and innovations to better inform patient-centered outcomes research investments at AHRQ through the Effective Health Care Program. The Healthcare Horizon Scanning System provides AHRQ a systematic process to identify and monitor emerging technologies and innovations in health care and to create an inventory of emerging technologies that have the highest potential for impact on clinical care, the health care system, patient outcomes, and costs. It will also be a tool for the public to identify and find information on new health care technologies and interventions. Any investigator or funder of research will be able to use the AHRQ Healthcare Horizon Scanning System to select potential topics for research. The health care technologies and innovations of interest for horizon scanning are those that have yet to diffuse into or become part of established health care practice. These health care interventions are still in the early stages of development or adoption except in the case of new applications of already-diffused technologies. Consistent with the definitions of health care interventions provided by the Institute of Medicine and the Federal Coordinating Council for Comparative Effectiveness Research, AHRQ is interested in innovations in drugs and biologics, medical devices, screening and diagnostic tests, procedures, services and programs, and care delivery. Horizon scanning involves two processes. The first is identifying and monitoring new and evolving health care interventions that are purported to or may hold potential to diagnose, treat, or otherwise manage a particular condition or to improve care delivery for a variety of conditions. The second is analyzing the relevant health care context in which these new and evolving interventions exist to understand their potential impact on clinical care, the health care system, patient outcomes, and costs. It is NOT the goal of the AHRQ Healthcare Horizon Scanning System to make predictions on the future use and costs of any health care technology. Rather, the reports will help to inform and guide the planning and prioritization of research resources. This edition of the Status Update lists interventions that have been identified and are being monitored. The next edition will be published in 2–3 months. We welcome comments on the list, which may be sent by mail to the Task Order Officer named in this report to: Agency for Healthcare Research and Quality, 540 Gaither Road, Rockville, MD 20850, or by email to: [email protected]. Richard Kronick, Ph.D. David Meyers, M.D. Director Acting Director Agency for Healthcare Research and Quality Center for Evidence and Practice Improvement Agency for Healthcare Research and Quality Elise Berliner, Ph.D. Task Order Officer Center for Evidence and Practice Improvement Agency for Healthcare Research and Quality ii Contents Introduction ............................................................................................................................................................................. 1 Section 1. Currently Tracked Interventions: 498 Interventions .............................................................................................. 3 Table 1. AHRQ Priority Condition: 01 Arthritis and Nontraumatic Joint Disease: 10 Interventions ....................... 4 Table 2. AHRQ Priority Condition: 02 Cancer: 186 Interventions ........................................................................... 9 Table 3. AHRQ Priority Condition: 03 Cardiovascular Disease: 49 Interventions ............................................... 144 Table 4. AHRQ Priority Condition: 04 Dementia (including Alzheimer’s: 17 Interventions ............................... 180 Table 5. AHRQ Priority Condition: 05 Depression and Other Mental Health Disorders: 19 Interventions .......... 190 Table 6. AHRQ Priority Condition: 06 Developmental Delays, Attention-Deficit Hyperactivity Disorder, and Autism: 7 Interventions ......................................................................................................................... 200 Table 7. AHRQ Priority Condition: 07 Diabetes Mellitus: 14 Interventions ......................................................... 204 Table 8. AHRQ Priority Condition: 08 Functional Limitations and Disability: 98 Interventions ......................... 216 Table 9. AHRQ Priority Condition: 09 Infectious Disease, Including HIV-AIDS: 40 Interventions ................... 276 Table 10. AHRQ Priority Condition: 10 Obesity: 8 Interventions ........................................................................ 295 Table 11. AHRQ Priority Condition: 11 Peptic Ulcer Disease and Dyspepsia: 9 Interventions ........................... 300 Table 12. AHRQ Priority Condition: 12 Pregnancy, Including Preterm Birth: 4 Interventions ............................ 305 Table 13. AHRQ Priority Condition: 13 Pulmonary Disease, Asthma: 17 Interventions...................................... 307 Table 14. AHRQ Priority Condition: 14 Substance Abuse: 13 Interventions ....................................................... 315 Table 15. AHRQ Priority Condition: 15 Cross-Cutting: 7 Interventions .............................................................. 326 Section 2. Interventions Added Since Last Update: 108 Interventions .............................................................................. 330 Table 16. AHRQ Priority Condition: 01 Arthritis and Nontraumatic Joint Disease: 5 Interventions ................... 331 Table 17. AHRQ Priority Condition: 02 Cancer: 34 Interventions ....................................................................... 334 Table 18. AHRQ Priority Condition: 03 Cardiovascular Disease: 8 Interventions ............................................... 357 Table 19. AHRQ Priority Condition: 04 Dementia (including Alzheimer’s: 1 Intervention ................................. 361 Table 20. AHRQ Priority Condition: 05 Depression and Other Mental Health Disorders: 0 Interventions .......... 361 Table 21. AHRQ Priority Condition: 06 Developmental Delays, Attention-Deficit Hyperactivity Disorder, and Autism: 0 Interventions ......................................................................................................................... 361 Table 22. AHRQ Priority Condition: 07 Diabetes Mellitus: 3 Interventions......................................................... 362 Table 23. AHRQ Priority Condition: 08 Functional Limitations and Disability: 32 Interventions ....................... 364 Table 24. AHRQ Priority Condition: 09 Infectious Disease, Including HIV-AIDS: 14 Interventions ................. 387 Table 25. AHRQ Priority Condition: 10 Obesity: 0 Interventions ........................................................................ 394 Table 26. AHRQ Priority Condition: 11 Peptic Ulcer Disease and Dyspepsia: 0 Interventions
Load more

Recommended publications
  • Clinical Protocol
    OncoMed Pharmaceuticals, Inc. Demcizumab CLINICAL PROTOCOL Protocol No. M18-006 Title: YOSEMITE: A 3-Arm Phase 2 Double-Blind Randomized StudY of Gemcitabine, Abraxane® Plus PlacebO versuS GEMcitabIne, Abraxane® plus 1 or 2 TruncatEd Courses of Demcizumab in Subjects with 1st-Line Metastatic Pancreatic Ductal Adenocarcinoma Version: 23 October 2014 Amendment 1: 24 November 2014 Amendment 2: 10 February 2015 Amendment 3: 28 May 2015 Amendment 4: 31 March 2016 Amendment 5: 19 December 2016 EudraCT Number: 2014‐003355‐56 Sponsor: OncoMed Pharmaceuticals, Inc. 800 Chesapeake Drive Redwood City, CA 94063 Phone: 650-995-8200 CONFIDENTIAL This document contains proprietary and confidential information of OncoMed Pharmaceuticals, Inc. Acceptance of this document constitutes agreement by the recipient that no previously unpublished information contained herein will be published or disclosed without the prior written approval of OncoMed Pharmaceuticals, Inc. with the exception that this document may be disclosed to study personnel under your supervision who need to know the contents for conducting the study and appropriate Institutional Review Boards/Ethics Committees under the condition that the personnel have agreed to keep this information confidential. The foregoing shall not apply to disclosure required by governmental regulations or laws; however, OncoMed Pharmaceuticals, Inc. shall be promptly notified of any such disclosure. Protocol M18-006, Amendment 5 Page 1 of 130 CONFIDENTIAL 19 December 2016 OncoMed Pharmaceuticals, Inc. Demcizumab SPONSOR CONTACTS Medical Monitor: ___________________ (Primary) ___________________________ Email: ___________________ Phone: ____________________ Medical Monitor: ___________________ (Secondary) ___________________ Email: ___________________ Phone: ___________________ Safety Reporting: Europe, Australia Phone: ___________________ Fax: ___________________ United States Phone: ___________________ Fax: ___________________ Protocol M18-006, Amendment 5 Page 2 of 130 CONFIDENTIAL 19 December 2016 OncoMed Pharmaceuticals, Inc.
    [Show full text]
  • Duvelisib Eliminates CLL B Cells, Impairs CLL- Supporting Cells, and Overcomes Ibrutinib Resistance in Preclinical Models
    Duvelisib Eliminates CLL B Cells, Impairs CLL- Supporting Cells, and Overcomes Ibrutinib Resistance in Preclinical Models Shih-Shih Chen ( [email protected] ) Karches Center for Oncology Research, the Feinstein Institutes for Medical Research Jacqueline Barrientos Karches Center for Oncology Research, the Feinstein Institutes for Medical Research Gerardo Ferrer Josep Carreras Leukaemia Research Institute (IJC) https://orcid.org/0000-0002-4084-6815 Priyadarshini Ravichandran Karches Center for Oncology Research, the Feinstein Institutes for Medical Research Michael Ibrahim Karches Center for Oncology Research, the Feinstein Institutes for Medical Research Yasmine Kieso Karches Center for Oncology Research, the Feinstein Institutes for Medical Research Jeff Kutok Innity Pharmaceuticals Marisa Peluso Innity Pharmaceuticals, Inc Sujata Sharma Innity Pharmaceuticals, Inc David Weaver Institute of Health Sciences, Anhui University Jonathan Pachter Verastem Inc. Kanti Rai The Karches Center for Oncology Research. The Feinstein Institutes for Medical Research. Nicholas Chiorazzi Karches Center for Oncology Research, the Feinstein Institutes for Medical Research Article Keywords: chronic lymphocytic leukemia, cancer therapy, Bruton’s Tyrosine Kinase (BTKi), phosphoinositide 3-kinase (PI3Ki) Page 1/23 Posted Date: July 21st, 2021 DOI: https://doi.org/10.21203/rs.3.rs-701669/v1 License: This work is licensed under a Creative Commons Attribution 4.0 International License. Read Full License Page 2/23 Abstract Inhibitors of Bruton’s Tyrosine Kinase (BTKi) and phosphoinositide 3-kinase (PI3Ki) have signicantly improved therapy of chronic lymphocytic leukemia (CLL). However, the emergence of resistance to BTKi has introduced an unmet therapeutic need. Here we demonstrate in vitro and in vivo the essential roles of PI3K-δ for CLL B-cell survival and migration and of PI3K-γ in T-cell migration and macrophage polarization; and more ecacious inhibition in CLL-cell burden by dual inhibition of PI3K-δ,γ.
    [Show full text]
  • Precision Medicine for Human Cancers with Notch Signaling Dysregulation (Review)
    INTERNATIONAL JOURNAL OF MOleCular meDICine 45: 279-297, 2020 Precision medicine for human cancers with Notch signaling dysregulation (Review) MASUKO KATOH1 and MASARU KATOH2 1M & M PrecMed, Tokyo 113-0033; 2Department of Omics Network, National Cancer Center, Tokyo 104-0045, Japan Received September 16, 2019; Accepted November 20, 2019 DOI: 10.3892/ijmm.2019.4418 Abstract. NOTCH1, NOTCH2, NOTCH3 and NOTCH4 are conjugate (ADC) Rova-T, and DLL3-targeting chimeric antigen transmembrane receptors that transduce juxtacrine signals of receptor‑modified T cells (CAR‑Ts), AMG 119, are promising the delta-like canonical Notch ligand (DLL)1, DLL3, DLL4, anti-cancer therapeutics, as are other ADCs or CAR-Ts targeting jagged canonical Notch ligand (JAG)1 and JAG2. Canonical tumor necrosis factor receptor superfamily member 17, Notch signaling activates the transcription of BMI1 proto-onco- CD19, CD22, CD30, CD79B, CD205, Claudin 18.2, fibro- gene polycomb ring finger, cyclin D1, CD44, cyclin dependent blast growth factor receptor (FGFR)2, FGFR3, receptor-type kinase inhibitor 1A, hes family bHLH transcription factor 1, tyrosine-protein kinase FLT3, HER2, hepatocyte growth factor hes related family bHLH transcription factor with YRPW receptor, NECTIN4, inactive tyrosine-protein kinase 7, inac- motif 1, MYC, NOTCH3, RE1 silencing transcription factor and tive tyrosine-protein kinase transmembrane receptor ROR1 transcription factor 7 in a cellular context-dependent manner, and tumor-associated calcium signal transducer 2. ADCs and while non-canonical Notch signaling activates NF-κB and Rac CAR-Ts could alter the therapeutic framework for refractory family small GTPase 1. Notch signaling is aberrantly activated cancers, especially diffuse-type gastric cancer, ovarian cancer in breast cancer, non-small-cell lung cancer and hematological and pancreatic cancer with peritoneal dissemination.
    [Show full text]
  • WO 2017/145013 Al 31 August 2017 (31.08.2017) P O P C T
    (12) INTERNATIONAL APPLICATION PUBLISHED UNDER THE PATENT COOPERATION TREATY (PCT) (19) World Intellectual Property Organization International Bureau (10) International Publication Number (43) International Publication Date WO 2017/145013 Al 31 August 2017 (31.08.2017) P O P C T (51) International Patent Classification: (81) Designated States (unless otherwise indicated, for every C07D 498/04 (2006.01) A61K 31/5365 (2006.01) kind of national protection available): AE, AG, AL, AM, C07D 519/00 (2006.01) A61P 25/00 (2006.01) AO, AT, AU, AZ, BA, BB, BG, BH, BN, BR, BW, BY, BZ, CA, CH, CL, CN, CO, CR, CU, CZ, DE, DJ, DK, DM, (21) Number: International Application DO, DZ, EC, EE, EG, ES, FI, GB, GD, GE, GH, GM, GT, PCT/IB20 17/050844 HN, HR, HU, ID, IL, IN, IR, IS, JP, KE, KG, KH, KN, (22) International Filing Date: KP, KR, KW, KZ, LA, LC, LK, LR, LS, LU, LY, MA, 15 February 2017 (15.02.2017) MD, ME, MG, MK, MN, MW, MX, MY, MZ, NA, NG, NI, NO, NZ, OM, PA, PE, PG, PH, PL, PT, QA, RO, RS, (25) Filing Language: English RU, RW, SA, SC, SD, SE, SG, SK, SL, SM, ST, SV, SY, (26) Publication Language: English TH, TJ, TM, TN, TR, TT, TZ, UA, UG, US, UZ, VC, VN, ZA, ZM, ZW. (30) Priority Data: 62/298,657 23 February 2016 (23.02.2016) US (84) Designated States (unless otherwise indicated, for every kind of regional protection available): ARIPO (BW, GH, (71) Applicant: PFIZER INC. [US/US]; 235 East 42nd Street, GM, KE, LR, LS, MW, MZ, NA, RW, SD, SL, ST, SZ, New York, New York 10017 (US).
    [Show full text]
  • Minutes of the CHMP Meeting 14-17 September 2020
    13 January 2021 EMA/CHMP/625456/2020 Corr.1 Human Medicines Division Committee for medicinal products for human use (CHMP) Minutes for the meeting on 14-17 September 2020 Chair: Harald Enzmann – Vice-Chair: Bruno Sepodes Disclaimers Some of the information contained in these minutes is considered commercially confidential or sensitive and therefore not disclosed. With regard to intended therapeutic indications or procedure scopes listed against products, it must be noted that these may not reflect the full wording proposed by applicants and may also vary during the course of the review. Additional details on some of these procedures will be published in the CHMP meeting highlights once the procedures are finalised and start of referrals will also be available. Of note, these minutes are a working document primarily designed for CHMP members and the work the Committee undertakes. Note on access to documents Some documents mentioned in the minutes cannot be released at present following a request for access to documents within the framework of Regulation (EC) No 1049/2001 as they are subject to on- going procedures for which a final decision has not yet been adopted. They will become public when adopted or considered public according to the principles stated in the Agency policy on access to documents (EMA/127362/2006). 1 Addition of the list of participants Official address Domenico Scarlattilaan 6 ● 1083 HS Amsterdam ● The Netherlands Address for visits and deliveries Refer to www.ema.europa.eu/how-to-find-us Send us a question Go to www.ema.europa.eu/contact Telephone +31 (0)88 781 6000 An agency of the European Union © European Medicines Agency, 2020.
    [Show full text]
  • 1 Randomized Trials of Retosiban Versus Placebo Or Atosiban In
    Randomized trials of retosiban versus placebo or atosiban in spontaneous preterm labor George Saade MDa, Andrew Shennan MDb, Kathleen J Beach MDc,1, Eran Hadar MDd, Barbara V Parilla MDe,2, Jerry Snidow PharmDf,3, Marcy Powell MDg, Timothy H Montague PhDh, Feng Liu PhDh,4, Yosuke Komatsu MDi,5, Laura McKain MDj,6, Steven Thornton DMk aDepartment of Obstetrics and Gynecology, University of Texas Medical Branch, Galveston, TX, USA; bDepartment of Women and Children’s Health, King’s College London, St Thomas’ Hospital, London, UK; cDepartment of Maternal and Fetal Medicine, GSK, Research Triangle Park, NC, USA; dHelen Schneider Hospital for Women, Rabin Medical Center, Petach-Tikva, Israel and Sackler Faculty of Medicine, Tel Aviv University, Tel Aviv, Israel; eDepartment of Obstetrics and Gynecology, Advocate Lutheran General Hospital, Park Ridge, IL, USA; fAlternative Discovery and Development, GSK, Research Triangle Park, NC, USA; gCentral Safety Department, GSK, Research Triangle Park, NC, USA; hClinical Statistics, Quantitative Sciences, GSK, Collegeville, PA, USA; iMaternal and Neonatal Health Unit, Alternative Discovery & Development, R&D, GSK, Research Triangle Park, NC, USA; jPharmacovigilance, PPD, Wilmington, NC, USA; kBarts and The London School of Medicine and Dentistry, Queen Mary University of London, London, UK 1At the time of the trial; 2At the time of the trial, present address: Rush Center for Maternal- Fetal Medicine, Aurora, IL, USA; 3At the time of the trial; 4At the time of the trial, present address: AstraZeneca,
    [Show full text]
  • 1 the Effect of an Oxytocin Receptor Antagonist (Retosiban, GSK221149A) on the 2 Response of Human Myometrial Explants to Prolonged Mechanical Stretch
    View metadata, citation and similar papers at core.ac.uk brought to you by CORE provided by Apollo 1 The effect of an oxytocin receptor antagonist (retosiban, GSK221149A) on the 2 response of human myometrial explants to prolonged mechanical stretch. 3 4 Alexandros A. Moraitis, Yolande Cordeaux, D. Stephen Charnock-Jones, Gordon C. S. 5 Smith. 6 Department of Obstetrics and Gynaecology, University of Cambridge; NIHR Cambridge 7 Comprehensive Biomedical Research Centre, CB2 2SW, UK. 8 9 Abbreviated title: Retosiban and myometrial contractility. 10 Key terms: Retosiban, myometrial contractility, preterm birth, multiple pregnancy, oxytocin 11 receptor. 12 Word count: 2203 13 Number of figures: 3 14 15 Correspondending author and person to whom reprint requests should be addressed: 16 Gordon CS Smith. Department of Obstetrics and Gynaecology, University of Cambridge, 17 The Rosie Hospital, Cambridge, CB2 0SW, UK. 18 Tel: 01223 763888/763890; Fax: 01223 763889; 19 E-mail: [email protected] 20 21 Disclosure statement: 22 GS receives/has received research support from GE (supply of two diagnostic ultrasound 23 systems) and Roche (supply of equipment and reagents for biomarker studies). GS has 24 been paid to attend advisory boards by GSK and Roche. GS has acted as a paid consultant 25 to GSK. GS is named inventor in a patent submitted by GSK (UK), for the use of retosiban to 26 prevent preterm birth in multiple pregnancy (PCT/EP2014/062602), based on the work 27 described in this paper. GS and DSCJ have been awarded £199,413 to fund further 28 research on retosiban by GSK. AM has received a travel grant by GSK to present at the 1 29 Society of Reproductive Investigation (SRI) annual conference in March 2015.
    [Show full text]
  • Zurampic (Lesinurad)
    Market Applicability Market DC GA KY MD NJ NY WA Applicable X X X X X X NA Zurampic (lesinurad) Override(s) Approval Duration Prior Authorization 1 year Quantity Limit Medications Quantity Limit Zurampic (lesinurad) May be subject to quantity limit APPROVAL CRITERIA Requests for Zurampic (lesinurad) may be approved if the following criteria are met: I. Individual has had a previous trial (medication samples/coupons/discount cards are excluded from consideration as a trial) and inadequate response (unable to achieve target serum uric acid levels) to one preferred xanthine oxidase inhibitor (allopurinol, febuxostat*); AND II. Individual has hyperuricemia associated with gout; AND III. Individual is unable to achieve target serum uric acid levels while on a xanthine oxidase inhibitor (such as allopurinol or febuxostat*); AND IV. Individual remains symptomatic (such as, but not limited to joint pain, swelling, limited range of motion, erythema) despite use of xanthine oxidase inhibitor; AND V. Individual will continue use of a xanthine oxidase inhibitor in conjunction with Zurampic. *requires prior authorization Zurampic (lesinurad) may not be approved for the following: I. Individual has severe renal impairment (creatinine clearance less than 30 mL/min), end stage renal disease, is on dialysis or is a kidney transplant recipient; OR II. Individual has Lesch-Nyhan syndrome or tumor lysis syndrome. PAGE 1 of 2 08/14/2019 This policy does not apply to health plans or member categories that do not have pharmacy benefits, nor does it apply to Medicare. Note that market specific restrictions or transition-of-care benefit limitations may apply. CRX-ALL-0429-19 Market Applicability Market DC GA KY MD NJ NY WA Applicable X X X X X X NA Note: Zurampic (lesinurad) has a black box warning indicating risk of acute renal failure is more common when Zurampic is used without a xanthine oxidase inhibitor.
    [Show full text]
  • Metabolism and Pharmacokinetics in the Development of New Therapeutics for Cocaine and Opioid Abuse
    University of Mississippi eGrove Electronic Theses and Dissertations Graduate School 2012 Metabolism And Pharmacokinetics In The Development Of New Therapeutics For Cocaine And Opioid Abuse Pradeep Kumar Vuppala University of Mississippi Follow this and additional works at: https://egrove.olemiss.edu/etd Part of the Pharmacy and Pharmaceutical Sciences Commons Recommended Citation Vuppala, Pradeep Kumar, "Metabolism And Pharmacokinetics In The Development Of New Therapeutics For Cocaine And Opioid Abuse" (2012). Electronic Theses and Dissertations. 731. https://egrove.olemiss.edu/etd/731 This Dissertation is brought to you for free and open access by the Graduate School at eGrove. It has been accepted for inclusion in Electronic Theses and Dissertations by an authorized administrator of eGrove. For more information, please contact [email protected]. METABOLISM AND PHARMACOKINETICS IN THE DEVELOPMENT OF NEW THERAPEUTICS FOR COCAINE AND OPIOID ABUSE A Dissertation presented in partial fulfillment of requirements for the degree of Doctor of Philosophy in Pharmaceutical Sciences in the Department of Pharmaceutics The University of Mississippi by PRADEEP KUMAR VUPPALA April 2012 Copyright © 2012 by Pradeep Kumar Vuppala All rights reserved ABSTRACT Cocaine and opioid abuse are a major public health concern and the cause of significant morbidity and mortality worldwide. The development of effective medication for cocaine and opioid abuse is necessary to reduce the impact of this issue upon the individual and society. The pharmacologic treatment for drug abuse has been based on one of the following strategies: agonist substitution, antagonist treatment, or symptomatic treatment. This dissertation is focused on the role of metabolism and pharmacokinetics in the development of new pharmacotherapies, CM304 (sigma-1 receptor antagonist), mitragynine and 7-hydroxymitragynine (µ-opioid receptor agonists), for the treatment of drug abuse.
    [Show full text]
  • Management of Side Effects of Antipsychotics
    Management of side effects of antipsychotics Oliver Freudenreich, MD, FACLP Co-Director, MGH Schizophrenia Program www.mghcme.org Disclosures I have the following relevant financial relationship with a commercial interest to disclose (recipient SELF; content SCHIZOPHRENIA): • Alkermes – Consultant honoraria (Advisory Board) • Avanir – Research grant (to institution) • Janssen – Research grant (to institution), consultant honoraria (Advisory Board) • Neurocrine – Consultant honoraria (Advisory Board) • Novartis – Consultant honoraria • Otsuka – Research grant (to institution) • Roche – Consultant honoraria • Saladax – Research grant (to institution) • Elsevier – Honoraria (medical editing) • Global Medical Education – Honoraria (CME speaker and content developer) • Medscape – Honoraria (CME speaker) • Wolters-Kluwer – Royalties (content developer) • UpToDate – Royalties, honoraria (content developer and editor) • American Psychiatric Association – Consultant honoraria (SMI Adviser) www.mghcme.org Outline • Antipsychotic side effect summary • Critical side effect management – NMS – Cardiac side effects – Gastrointestinal side effects – Clozapine black box warnings • Routine side effect management – Metabolic side effects – Motor side effects – Prolactin elevation • The man-in-the-arena algorithm www.mghcme.org Receptor profile and side effects • Alpha-1 – Hypotension: slow titration • Dopamine-2 – Dystonia: prophylactic anticholinergic – Akathisia, parkinsonism, tardive dyskinesia – Hyperprolactinemia • Histamine-1 – Sedation – Weight gain
    [Show full text]
  • New Therapeutic Agents Marketed in 2015: Part 4 Amy M
    CPE New therapeutic agents marketed in 2015: Part 4 Amy M. Lugo and Brian Park Amy M. Lugo, PharmD, BCPS, BC-ADM, Abstract FAPhA, Clinical Pharmacy Specialist, Pharmacy Operations Division, Formu- lary Management Branch, Defense Health Objective: To provide information about the most important properties of new Agency, San Antonio therapeutic agents approved by FDA and first marketed in 2015. Brian Park, PharmD candidate, University of Data sources: Product labeling supplemented selectively with published stud- New England College of Pharmacy, Portland, ies and drug information reference sources. ME Data synthesis: This review covers 11 new therapeutic agents approved by FDA Correspondence: Amy M. Lugo, 7800 and first marketed in the United States in 2015: selexipag, cobimetinib, osimertinib, IH-10 W, Ste. 335, San Antonio, TX 78230; necitumumab, alectinib, insulin degludec, lesinurad, mepolizumab, brexpiprazole, [email protected] cariprazine, and flibanserin. Indications and information on dosage and adminis- Disclosure: The authors declare no conflicts tration for these agents are reviewed, as well as efficacy, safety, the most important of interest or financial interests in any product or service mentioned in this article. pharmacokinetic properties, drug interactions, and other precautions. Practical considerations for use of these new agents also are discussed. Whenever possible, Department of Defense (DoD) disclaimer: The information discussed here represents properties of the new drugs are compared with those of older agents marketed for the views of the author and does not neces- the same indications. sarily reflect the views of DoD or the Depart- Summary: Selexipag is the second oral prostacyclin agonist for the treatment ments of the Army, Navy, or Air Force.
    [Show full text]
  • |||||||||||||III US005202354A United States Patent (19) (11) Patent Number: 5,202,354 Matsuoka Et Al
    |||||||||||||III US005202354A United States Patent (19) (11) Patent Number: 5,202,354 Matsuoka et al. 45) Date of Patent: Apr. 13, 1993 (54) COMPOSITION AND METHOD FOR 4,528,295 7/1985 Tabakoff .......... ... 514/562 X REDUCING ACETALDEHYDE TOXCTY 4,593,020 6/1986 Guinot ................................ 514/811 (75) Inventors: Masayoshi Matsuoka, Habikino; Go OTHER PUBLICATIONS Kito, Yao, both of Japan Sprince et al., Agents and Actions, vol. 5/2 (1975), pp. 73) Assignee: Takeda Chemical Industries, Ltd., 164-173. Osaka, Japan Primary Examiner-Arthur C. Prescott (21) Appl. No.: 839,265 Attorney, Agent, or Firn-Wenderoth, Lind & Ponack 22) Filed: Feb. 21, 1992 (57) ABSTRACT A novel composition and method are disclosed for re Related U.S. Application Data ducing acetaldehyde toxicity, especially for preventing (63) Continuation of Ser. No. 13,443, Feb. 10, 1987, aban and relieving hangover symptoms in humans. The com doned. position comprises (a) a compound of the formula: (30) Foreign Application Priority Data Feb. 18, 1986 JP Japan .................................. 61-34494 51) Int: C.5 ..................... A01N 37/00; A01N 43/08 52 U.S. C. ................................. ... 514/562; 514/474; 514/81 wherein R is hydrogen or an acyl group; R' is thiol or 58) Field of Search ................ 514/557, 562, 474,811 sulfonic group; and n is an integer of 1 or 2, (b) ascorbic (56) References Cited acid or a salt thereof and (c) a disulfide type thiamine derivative or a salt thereof. The composition is orally U.S. PATENT DOCUMENTS administered, preferably in the form of tablets. 2,283,817 5/1942 Martin et al.
    [Show full text]