Dexmethylphenidate
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Methylphenidate Hydrochloride
Application for Inclusion to the 22nd Expert Committee on the Selection and Use of Essential Medicines: METHYLPHENIDATE HYDROCHLORIDE December 7, 2018 Submitted by: Patricia Moscibrodzki, M.P.H., and Craig L. Katz, M.D. The Icahn School of Medicine at Mount Sinai Graduate Program in Public Health New York NY, United States Contact: [email protected] TABLE OF CONTENTS Page 3 Summary Statement Page 4 Focal Point Person in WHO Page 5 Name of Organizations Consulted Page 6 International Nonproprietary Name Page 7 Formulations Proposed for Inclusion Page 8 International Availability Page 10 Listing Requested Page 11 Public Health Relevance Page 13 Treatment Details Page 19 Comparative Effectiveness Page 29 Comparative Safety Page 41 Comparative Cost and Cost-Effectiveness Page 45 Regulatory Status Page 48 Pharmacoepial Standards Page 49 Text for the WHO Model Formulary Page 52 References Page 61 Appendix – Letters of Support 2 1. Summary Statement of the Proposal for Inclusion of Methylphenidate Methylphenidate (MPH), a central nervous system (CNS) stimulant, of the phenethylamine class, is proposed for inclusion in the WHO Model List of Essential Medications (EML) & the Model List of Essential Medications for Children (EMLc) for treatment of Attention-Deficit/Hyperactivity Disorder (ADHD) under ICD-11, 6C9Z mental, behavioral or neurodevelopmental disorder, disruptive behavior or dissocial disorders. To date, the list of essential medications does not include stimulants, which play a critical role in the treatment of psychotic disorders. Methylphenidate is proposed for inclusion on the complimentary list for both children and adults. This application provides a systematic review of the use, efficacy, safety, availability, and cost-effectiveness of methylphenidate compared with other stimulant (first-line) and non-stimulant (second-line) medications. -
Addictions and the Brain
9/18/2012 Addictions and the Brain TAAP Conference September 14, 2012 Acknowledgements • La Hacienda Treatment Center • American Society of Addiction Medicine • National Institute of Drug Abuse © 2012 La Hacienda Treatment Center. All rights reserved. 1 9/18/2012 Definition • A primary, progressive biochemical, psychosocial, genetically transmitted chronic disease of relapse who’s hallmarks are denial, loss of control and unmanageability. DSM IV Criteria for dependency: At least 3 of the 7 below 1. Withdrawal 2. Tolerance 3. The substance is taken in larger amounts or over a longer period than was intended. 4. There is a persistent desire or unsuccessful efforts to cut down or control substance use. 5. A great deal of time is spent in activities necessary to obtain the substance, use the substance, or recover from its effects. 6. Important social, occupational, or recreational activities are given up or reduced because of the substance use. 7. The substance use is continued despite knowledge of having a persistent or recurrent physical or psychological problem that is likely to have been caused or exacerbated by the substance. © 2012 La Hacienda Treatment Center. All rights reserved. 2 9/18/2012 Dispute between behavior and disease Present understanding of the Hypothalamus location of the disease hypothesis. © 2012 La Hacienda Treatment Center. All rights reserved. 3 9/18/2012 © 2012 La Hacienda Treatment Center. All rights reserved. 4 9/18/2012 © 2012 La Hacienda Treatment Center. All rights reserved. 5 9/18/2012 Dispute regarding behavior versus disease © 2012 La Hacienda Treatment Center. All rights reserved. 6 9/18/2012 © 2012 La Hacienda Treatment Center. -
The Stimulants and Hallucinogens Under Consideration: a Brief Overview of Their Chemistry and Pharmacology
Drug and Alcohol Dependence, 17 (1986) 107-118 107 Elsevier Scientific Publishers Ireland Ltd. THE STIMULANTS AND HALLUCINOGENS UNDER CONSIDERATION: A BRIEF OVERVIEW OF THEIR CHEMISTRY AND PHARMACOLOGY LOUIS S. HARRIS Dcparlmcnl of Pharmacology, Medical College of Virginia, Virginia Commonwealth Unwersity, Richmond, VA 23298 (U.S.A.) SUMMARY The substances under review are a heterogenous set of compounds from a pharmacological point of view, though many have a common phenylethyl- amine structure. Variations in structure lead to marked changes in potency and characteristic action. The introductory material presented here is meant to provide a set of chemical and pharmacological highlights of the 28 substances under con- sideration. The most commonly used names or INN names, Chemical Abstract (CA) names and numbers, and elemental formulae are provided in the accompanying figures. This provides both some basic information on the substances and a starting point for the more detailed information that follows in the individual papers by contributors to the symposium. Key words: Stimulants, their chemistry and pharmacology - Hallucinogens, their chemistry and pharmacology INTRODUCTION Cathine (Fig. 1) is one of the active principles of khat (Catha edulis). The structure has two asymmetric centers and exists as two geometric isomers, each of which has been resolved into its optical isomers. In the plant it exists as d-nor-pseudoephedrine. It is a typical sympathomimetic amine with a strong component of amphetamine-like activity. The racemic mixture is known generically in this country and others as phenylpropanolamine (dl- norephedrine). It is widely available as an over-the-counter (OTC) anti- appetite agent and nasal decongestant. -
Anti-Inflammatory Effects of Amantadine and Memantine
Journal of Personalized Medicine Communication Anti-Inflammatory Effects of Amantadine and Memantine: Possible Therapeutics for the Treatment of Covid-19? Félix Javier Jiménez-Jiménez 1,* , Hortensia Alonso-Navarro 1 , Elena García-Martín 2 and José A. G. Agúndez 2 1 Section of Neurology, Hospital Universitario del Sureste, Arganda del Rey, E-28500 Madrid, Spain; [email protected] 2 University Institute of Molecular Pathology Biomarkers, UNEx. ARADyAL Instituto de Salud Carlos III, E-10071 Cáceres, Spain; [email protected] (E.G.-M.); [email protected] (J.A.G.A.) * Correspondence: [email protected]; Tel.: +34-636968395 Received: 2 October 2020; Accepted: 6 November 2020; Published: 9 November 2020 Abstract: We have reviewed current data on the anti-inflammatory effects of amantadine and memantine in clinical and in vivo models of inflammation, and we propose that these effects have potential interest for the treatment of the SARS-CoV-2 infection (COVID-19 disease). To that end, we performed a literature search using the PubMed Database from 1966 up to October 31 2020, crossing the terms “amantadine” and “memantine” with “inflammation” and “anti-inflammatory”. Amantadine and/or memantine have shown anti-inflammatory effects in chronic hepatitis C, in neuroinflammation induced by sepsis and by lipopolysaccharides, experimental models of multiple sclerosis, spinal cord injury, and respiratory diseases. Since the inflammatory response is one of the main pathogenetic mechanisms in the progression of the SARS-CoV-2 infection, anti-inflammatory effects of amantadine and memantine could be hypothetically useful in the treatment of this condition. This potential utility deserves further research. Keywords: amantadine; memantine; anti-inflammatory effects; SARS-Cov-2; COVID-19; therapy 1. -
(19) United States (12) Patent Application Publication (10) Pub
US 20130289061A1 (19) United States (12) Patent Application Publication (10) Pub. No.: US 2013/0289061 A1 Bhide et al. (43) Pub. Date: Oct. 31, 2013 (54) METHODS AND COMPOSITIONS TO Publication Classi?cation PREVENT ADDICTION (51) Int. Cl. (71) Applicant: The General Hospital Corporation, A61K 31/485 (2006-01) Boston’ MA (Us) A61K 31/4458 (2006.01) (52) U.S. Cl. (72) Inventors: Pradeep G. Bhide; Peabody, MA (US); CPC """"" " A61K31/485 (201301); ‘4161223011? Jmm‘“ Zhu’ Ansm’ MA. (Us); USPC ......... .. 514/282; 514/317; 514/654; 514/618; Thomas J. Spencer; Carhsle; MA (US); 514/279 Joseph Biederman; Brookline; MA (Us) (57) ABSTRACT Disclosed herein is a method of reducing or preventing the development of aversion to a CNS stimulant in a subject (21) App1_ NO_; 13/924,815 comprising; administering a therapeutic amount of the neu rological stimulant and administering an antagonist of the kappa opioid receptor; to thereby reduce or prevent the devel - . opment of aversion to the CNS stimulant in the subject. Also (22) Flled' Jun‘ 24’ 2013 disclosed is a method of reducing or preventing the develop ment of addiction to a CNS stimulant in a subj ect; comprising; _ _ administering the CNS stimulant and administering a mu Related U‘s‘ Apphcatlon Data opioid receptor antagonist to thereby reduce or prevent the (63) Continuation of application NO 13/389,959, ?led on development of addiction to the CNS stimulant in the subject. Apt 27’ 2012’ ?led as application NO_ PCT/US2010/ Also disclosed are pharmaceutical compositions comprising 045486 on Aug' 13 2010' a central nervous system stimulant and an opioid receptor ’ antagonist. -
Oregon Dur Board Newsletter a N E Vidence B Ased D Rug T Herapy R Esource Copyright 2002 Oregon State University
OREGON DUR BOARD NEWSLETTER A N E VIDENCE B ASED D RUG T HERAPY R ESOURCE COPYRIGHT 2002 OREGON STATE UNIVERSITY. ALL RIGHTS RESERVED Volume 4, Issue 2 Also available on the web and via e-mail list-serve at April 2002 http://pharmacy.orst.edu/drug_policy/drug_policy.html A Review of Stimulant Medications By Ann Hamer, Pharm. D., OSU College of Pharmacy Attention deficit hyperactivity disorder (ADHD) is a psychiatric disorder four hours (5,6). Measures of efficacy included behavior frequency, characterized by inattention, hyperactivity, or impulsivity that is more completion and accuracy of academic problems, independent frequent or severe than is appropriate for the patient’s developmental observations, as well as teacher and counselor ratings. The extended level(1). It is estimated that 3 to 7 % of children have ADHD making it one release property of Concerta is based on its OROS delivery system (an of the most common psychiatric disorders of childhood and osmotically active trilayer core surrounded by a semipermeable membrane adolescence(2). with an immediate-release drug overcoat)(7). PHARMACOTHERAPY Patients new to methylphenidate should start Concerta at a dose of 18mg Stimulants are considered first-line agents for the treatment of children once daily. The dose may be adjusted based on the patient’s response in (greater than six years of age) with ADHD and are the only agents increments of 18mg per week to a maximum recommended dose of approved by the Food and Drug Administration (FDA) for this purpose(3). 54mg/day. The recommended dose conversion for patients currently Stimulant medications (including methylphenidate preparations, taking methylphenidate is summarized as follows: dextroamphetamine preparations, and pemoline) have CNS and RECOMMENDED CURRENT METHYLPHENIDATE DOSE respiratory stimulant properties and weak sympathomimetic activity. -
Positron Emission Tomography Studies of Potential Mechanisms Underlying Phencyclidine-Induced Alterations in Striatal Dopamine
Neuropsychopharmacology (2003) 28, 2192–2198 & 2003 Nature Publishing Group All rights reserved 0893-133X/03 $25.00 www.neuropsychopharmacology.org Positron Emission Tomography Studies of Potential Mechanisms Underlying Phencyclidine-Induced Alterations in Striatal Dopamine ,1,2 2 1,2 Wynne K Schiffer* , Jean Logan and Stephen L Dewey 1SUNY Stony Brook, Department of Neurobiology and Behavior, Stony Brook, NY, USA; 2Brookhaven National Laboratory, Chemistry Department, Upton, NY, USA 11 Positron emission tomography (PET), in combination with C-raclopride, was used to examine the effects of phencyclidine (PCP) on dopamine (DA) in the primate striatum. In addition, we explored the hypotheses that GABAergic pathways as well as molecular targets beyond the N-methyl-D-aspartate (NMDA) receptor complex (ie dopamine transporter proteins, DAT) contribute to PCP’s effects. In 11 the first series of experiments, C-raclopride was administered at baseline and 30 min following intravenous PCP administration. In the second series of studies, g-vinyl GABA (GVG) was used to assess whether enhanced GABAergic tone altered NMDA antagonist- induced changes in DA. Animals received an initial PET scan followed by pretreatment with GVG (300 mg/kg), then PCP 30 min prior to 11 a second scan. Finally, we explored the possible contributions of DAT blockade to PCP-induced increases in DA. By examining C- cocaine binding a paradigm in which PCP was coadministered with the radiotracer, we assessed the direct competition between these 11 two compounds for the DAT. At 0.1, 0.5, and 1.0 mg/kg, PCP decreased C-raclopride binding by 2.1, 14.9 7 2.2 and 8.18 7 1.1%, 11 respectively. -
Provider Notice
Mental Health Provider Quick Reference ▪ For current information visit http://kentucky.fhsc.com/pharmacy/default.asp ▪ To access the complete Preferred Drug List, click on the "Providers" tab and select "Drug Information" ▪ Managed Access Program/Prior Authorization: 800-477-3071 ▪ Mental Health Provider Prior Authorization FAX line: 800-453-2273 Class All are covered first tier with PA which may be obtained electronically (or by fax) within appropriate dosage, duplicate therapy Atypical Antipsychotics and ICD9 requirements Class First Generation Antipsychotics All are covered first tier without restriction Class Anticonvulsants All generic products are covered first tier without restriction. Brand products are second tier. CNS Stimulants for Patients <= 18 years old DRUG COPAY TIER PA MAXIMUM QUANTITY COMMENTS REQUIRED AVAILABLE WITHOUT (CLINICAL OR PRIOR AUTHORIZATION PDL) ALONE COMBINED SHORT-ACTING CNS STIMULANTS Adderall N/A NO 90 Any Patient may receive a total of up to 90 Amphetamine salt combo combination of dosage units/30 days alone, or in short-acting combination with other short-acting Dexmethylphenidate CNS stimulants (Adderall, Amphetamine Salt Focalin Stimulants not Combo, Dexmethylphenidate, and Focalin), to exceed 90 independent of long-acting stimulants dosage units (Adderall XR, Concerta, Focalin XR, and Vyvanse) and Strattera quantities LONG-ACTING CNS STIMULANTS Adderall XR N/A NO 60 Any Patient may receive a total of up to 60 Concerta combination of dosage units/30 days alone, or in Focalin XR extended combination -
(12) United States Patent (10) Patent No.: US 9,469,601 B2 Vacher Et Al
USOO94.69601 B2 (12) United States Patent (10) Patent No.: US 9,469,601 B2 Vacher et al. (45) Date of Patent: Oct. 18, 2016 (54) AMINOCYCLOBUTANE DERIVATIVES, FOREIGN PATENT DOCUMENTS METHOD FOR PREPARING SAME AND THE EP 0 747 348 A1 12/1996 USE THEREOF AS DRUGS EP O747348 A1 * 12, 1996 ............. CO7B 57/OO WO WO 98.07447 A1 2, 1998 (71) Applicant: PIERRE FABRE MEDICAMENT, WO WO 99.12537 A1 3, 1999 Boulogne-Billancourt (FR) WO WO 99.52848 A1 10, 1999 WO WOOOO3716 A1 1, 2000 WO WOOO, 51607 A1 9, 2000 (72) Inventors: Bernard Vacher, Castres (FR); Elodie WO WO 03/06165.6 A1 T 2003 Blanc, Semalens (FR); Ronan WO WO O3,063797 A2 8, 2003 Depoortere, Castres (FR) WO WO 2006/081179 A1 8, 2006 WO WO 2008/092.955 A1 8, 2008 WO WO 2009/O29618 A1 3, 2009 (73) Assignee: PIERRE FABRE MEDICAMENT, WO WO 2009/06961.0 A1 6, 2009 Boulogne-Billancourt (FR) WO WO 2009/092324 A1 T 2009 WO WO 2010/036937 A1 4/2010 (*) Notice: Subject to any disclaimer, the term of this WO WO 2010/037533 A1 4, 2010 patent is extended or adjusted under 35 (Continued) U.S.C. 154(b) by 0 days. OTHER PUBLICATIONS (21) Appl. No.: 14/649,448 Aarts et al., “Novel Treatment of Excitotoxicity: Targeted Disrup (22) PCT Filed: Dec. 4, 2013 tion of Intracellular Signalling from Glutamate Receptors,” Bio chemical Pharmacology, vol. 66, 2003, pp. 877-886. (86). PCT No.: PCT/EP2013/075481 (Continued) S 371 (c)(1), (2) Date: Jun. -
Phencyclidine: an Update
Phencyclidine: An Update U.S. DEPARTMENT OF HEALTH AND HUMAN SERVICES • Public Health Service • Alcohol, Drug Abuse and Mental Health Administration Phencyclidine: An Update Editor: Doris H. Clouet, Ph.D. Division of Preclinical Research National Institute on Drug Abuse and New York State Division of Substance Abuse Services NIDA Research Monograph 64 1986 DEPARTMENT OF HEALTH AND HUMAN SERVICES Public Health Service Alcohol, Drug Abuse, and Mental Health Administratlon National Institute on Drug Abuse 5600 Fishers Lane Rockville, Maryland 20657 For sale by the Superintendent of Documents, U.S. Government Printing Office Washington, DC 20402 NIDA Research Monographs are prepared by the research divisions of the National lnstitute on Drug Abuse and published by its Office of Science The primary objective of the series is to provide critical reviews of research problem areas and techniques, the content of state-of-the-art conferences, and integrative research reviews. its dual publication emphasis is rapid and targeted dissemination to the scientific and professional community. Editorial Advisors MARTIN W. ADLER, Ph.D. SIDNEY COHEN, M.D. Temple University School of Medicine Los Angeles, California Philadelphia, Pennsylvania SYDNEY ARCHER, Ph.D. MARY L. JACOBSON Rensselaer Polytechnic lnstitute National Federation of Parents for Troy, New York Drug Free Youth RICHARD E. BELLEVILLE, Ph.D. Omaha, Nebraska NB Associates, Health Sciences Rockville, Maryland REESE T. JONES, M.D. KARST J. BESTEMAN Langley Porter Neuropsychiatric lnstitute Alcohol and Drug Problems Association San Francisco, California of North America Washington, D.C. DENISE KANDEL, Ph.D GILBERT J. BOTV N, Ph.D. College of Physicians and Surgeons of Cornell University Medical College Columbia University New York, New York New York, New York JOSEPH V. -
Treatment of Patients with Substance Use Disorders Second Edition
PRACTICE GUIDELINE FOR THE Treatment of Patients With Substance Use Disorders Second Edition WORK GROUP ON SUBSTANCE USE DISORDERS Herbert D. Kleber, M.D., Chair Roger D. Weiss, M.D., Vice-Chair Raymond F. Anton Jr., M.D. To n y P. G e o r ge , M .D . Shelly F. Greenfield, M.D., M.P.H. Thomas R. Kosten, M.D. Charles P. O’Brien, M.D., Ph.D. Bruce J. Rounsaville, M.D. Eric C. Strain, M.D. Douglas M. Ziedonis, M.D. Grace Hennessy, M.D. (Consultant) Hilary Smith Connery, M.D., Ph.D. (Consultant) This practice guideline was approved in December 2005 and published in August 2006. A guideline watch, summarizing significant developments in the scientific literature since publication of this guideline, may be available in the Psychiatric Practice section of the APA web site at www.psych.org. 1 Copyright 2010, American Psychiatric Association. APA makes this practice guideline freely available to promote its dissemination and use; however, copyright protections are enforced in full. No part of this guideline may be reproduced except as permitted under Sections 107 and 108 of U.S. Copyright Act. For permission for reuse, visit APPI Permissions & Licensing Center at http://www.appi.org/CustomerService/Pages/Permissions.aspx. AMERICAN PSYCHIATRIC ASSOCIATION STEERING COMMITTEE ON PRACTICE GUIDELINES John S. McIntyre, M.D., Chair Sara C. Charles, M.D., Vice-Chair Daniel J. Anzia, M.D. Ian A. Cook, M.D. Molly T. Finnerty, M.D. Bradley R. Johnson, M.D. James E. Nininger, M.D. Paul Summergrad, M.D. Sherwyn M. -
Drug Abuse Urine Tests: False-Positive Results Joseph A
University of the Pacific Scholarly Commons School of Pharmacy and Health Sciences Faculty Thomas J. Long School of Pharmacy and Health Articles Sciences 3-1-2005 Drug abuse urine tests: false-positive results Joseph A. Woelfel University of the Pacific, [email protected] Follow this and additional works at: https://scholarlycommons.pacific.edu/phs-facarticles Part of the Pharmacy and Pharmaceutical Sciences Commons Recommended Citation Woelfel, J. A. (2005). Drug abuse urine tests: false-positive results. Pharmacist’s Letter & Prescriber’s Letter, 21(3), 1–5. https://scholarlycommons.pacific.edu/phs-facarticles/49 This Article is brought to you for free and open access by the Thomas J. Long School of Pharmacy and Health Sciences at Scholarly Commons. It has been accepted for inclusion in School of Pharmacy and Health Sciences Faculty Articles by an authorized administrator of Scholarly Commons. For more information, please contact [email protected]. ® Detail-Document #210314 ® −This Detail-Document accompanies the related article published in− PHARMACIST’S LETTER / PRESCRIBER’S LETTER March 2005 ~ Volume 21 ~ Number 210314 Drug Abuse Urine Tests: False-positive Results Lead author: Joseph A. Woelfel, Ph.D., FASCP, R.Ph., Assistant Editor Health care professionals are frequently asked questions about false-positive drug testing results. Testing is a common practice in work settings, rehabilitation programs, the military, and legal and judicial venues. Home testing is popular with the availability of test kits to alleviate parental or job-seeker concerns. Federally regulated workplace drug testing and most private sector workplace programs specify urine testing as their initial standard test. Other expanded tests may be required in some settings.