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Pharmacology and Toxicology of Amphetamine and Related Designer Drugs
Pharmacology and Toxicology of Amphetamine and Related Designer Drugs U.S. DEPARTMENT OF HEALTH AND HUMAN SERVICES • Public Health Service • Alcohol Drug Abuse and Mental Health Administration Pharmacology and Toxicology of Amphetamine and Related Designer Drugs Editors: Khursheed Asghar, Ph.D. Division of Preclinical Research National Institute on Drug Abuse Errol De Souza, Ph.D. Addiction Research Center National Institute on Drug Abuse NIDA Research Monograph 94 1989 U.S. DEPARTMENT OF HEALTH AND HUMAN SERVICES Public Health Service Alcohol, Drug Abuse, and Mental Health Administration National Institute on Drug Abuse 5600 Fishers Lane Rockville, MD 20857 For sale by the Superintendent of Documents, U.S. Government Printing Office Washington, DC 20402 Pharmacology and Toxicology of Amphetamine and Related Designer Drugs ACKNOWLEDGMENT This monograph is based upon papers and discussion from a technical review on pharmacology and toxicology of amphetamine and related designer drugs that took place on August 2 through 4, 1988, in Bethesda, MD. The review meeting was sponsored by the Biomedical Branch, Division of Preclinical Research, and the Addiction Research Center, National Institute on Drug Abuse. COPYRIGHT STATUS The National Institute on Drug Abuse has obtained permission from the copyright holders to reproduce certain previously published material as noted in the text. Further reproduction of this copyrighted material is permitted only as part of a reprinting of the entire publication or chapter. For any other use, the copyright holder’s permission is required. All other matieral in this volume except quoted passages from copyrighted sources is in the public domain and may be used or reproduced without permission from the Institute or the authors. -
212102Orig1s000
CENTER FOR DRUG EVALUATION AND RESEARCH APPLICATION NUMBER: 212102Orig1s000 OTHER REVIEW(S) Department of Health and Human Services Food and Drug Administration Center for Drug Evaluation and Research | Office of Surveillance and Epidemiology (OSE) Epidemiology: ARIA Sufficiency Date: June 29, 2020 Reviewer: Silvia Perez-Vilar, PharmD, PhD Division of Epidemiology I Team Leader: Kira Leishear, PhD, MS Division of Epidemiology I Division Director: CAPT Sukhminder K. Sandhu, PhD, MPH, MS Division of Epidemiology I Subject: ARIA Sufficiency Memo for Fenfluramine-associated Valvular Heart Disease and Pulmonary Arterial Hypertension Drug Name(s): FINTEPLA (Fenfluramine hydrochloride, ZX008) Application Type/Number: NDA 212102 Submission Number: 212102/01 Applicant/sponsor: Zogenix, Inc. OSE RCM #: 2020-953 The original ARIA memo was dated June 23, 2020. This version, dated June 29, 2020, was amended to include “Assess a known serious risk” as FDAAA purpose (per Section 505(o)(3)(B)) to make it consistent with the approved labeling. The PMR development template refers to the original memo, dated June 23, 2020. Page 1 of 13 Reference ID: 46331494640015 EXECUTIVE SUMMARY (place “X” in appropriate boxes) Memo type -Initial -Interim -Final X X Source of safety concern -Peri-approval X X -Post-approval Is ARIA sufficient to help characterize the safety concern? Safety outcome Valvular Pulmonary heart arterial disease hypertension (VHD) (PAH) -Yes -No X X If “No”, please identify the area(s) of concern. -Surveillance or Study Population X X -Exposure -Outcome(s) of Interest X X -Covariate(s) of Interest X X -Surveillance Design/Analytic Tools Page 2 of 13 Reference ID: 46331494640015 1. -
Revisão Pharmacological Treatment of Obesity
Pharmacological Treatment of Obesity revisão ABSTRACT Marcio C. Mancini This review offers an overview of physiological agents, current therapeu- Alfredo Halpern tics, as well as medications, which have been extensively used and those agents not currently available or non-classically considered anti-obesity drugs. As obesity — particularly that of central distribution — represents an important triggering factor for insulin resistance, its pharmacological treatment is relevant in the context of metabolic syndrome control. The authors present an extensive review on the criteria for anti-obesity man- agement efficacy, on physiological mechanisms that regulate central and/or peripheral energy homeostasis (nutrients, monoamines, and pep- tides), on β-phenethylamine pharmacological derivative agents (fenflu- ramine, dexfenfluramine, phentermine and sibutramine), tricyclic deriva- tives (mazindol), phenylpropanolamine derivatives (ephedrin, phenyl- propanolamine), phenylpropanolamine oxytrifluorphenyl derivative (flu- oxetine), a naftilamine derivative (sertraline) and a lipstatine derivative (orlistat). An analysis of all clinical trials — over ten-week long — is also presented for medications used in the management of obesity, as well as data about future medications, such as a the inverse cannabinoid agonist, rimonabant. (Arq Bras Endocrinol Metab 2006;50/2:377-389) Keywords: Obesity; Treatment; Anfepramone; Mazindol; Sibutramine; Endocrinology and Metabology Orlistat; Rimonabant Division, Hospital das Clínicas, University of São Paulo Medical -
Drug-Drug Discrimination: Stimulus Properties of Drugs of Abuse Upon a Serotonergic-Dopaminergic Continuum
Pharmacology Biochemistry and Behavior, Vol. 56, No. 1, pp. 89±96, 1997 Copyright 1997 Elsevier Science Inc. Printed in the USA. All rights reserved 0091-3057/97 $17.00 1 .00 PII S0091-3057(96)00161-X Drug-Drug Discrimination: Stimulus Properties of Drugs of Abuse Upon a Serotonergic-Dopaminergic Continuum MARTIN D. SCHECHTER Department of Pharmacology, Northeastern Ohio Universities College of Medicine, 4209 S.R. 44, Rootstown, Ohio 44272 USA Received 14 December 1995; Revised 5 March 1996; Accepted 13 March 1996 SCHECHTER, M. D. Drug-drug discrimination: Stimulus properties of drugs of abuse upon a serotonergic-dopaminergic continuum. PHARMACOL BIOCHEM BEHAV 56(1) 89±96, 1997.ÐTen male N/Nih rats were trained to discriminate between the interoceptive cues produced by the purportedly dopaminergically-mediated drug d-amphetamine at 0.4 mg/kg intraperitoneally administered 20 min prior to training and those produced by the purportedly serotonergically-active agent norfen¯uramine at 0.7 mg/kg. Once this discrimination was successfully acquired, the rats were tested with saline and with both drugs administered simultaneously and these manipulations were seen to produce random responding; indicating roughly equivalent cueing strength. Subsequently, various drugs thought to act upon serotonergic neurons, i.e., LSD and MDMA, were tested and shown to generalize in a dose-responsive manner to the norfen¯uramine-appropriate lever. In contrast, the dopaminergically-active agent methcathinone and the D3 agonist 7-OH-DPAT produced generalization on the amphetamine- appropriate lever. Results are discussed in light of the increased speci®city of behavioral testing available in a drug vs. -
Schedules of Controlled Substances (.Pdf)
PURSUANT TO THE TEXAS CONTROLLED SUBSTANCES ACT, HEALTH AND SAFETY CODE, CHAPTER 481, THESE SCHEDULES SUPERCEDE PREVIOUS SCHEDULES AND CONTAIN THE MOST CURRENT VERSION OF THE SCHEDULES OF ALL CONTROLLED SUBSTANCES FROM THE PREVIOUS SCHEDULES AND MODIFICATIONS. This annual publication of the Texas Schedules of Controlled Substances was signed by John Hellerstedt, M.D., Commissioner of Health, and will take effect 21 days following publication of this notice in the Texas Register. Changes to the schedules are designated by an asterisk (*). Additional information can be obtained by contacting the Department of State Health Services, Drugs and Medical Devices Unit, P.O. Box 149347, Austin, Texas 78714-9347. The telephone number is (512) 834-6755 and the website address is http://www.dshs.texas.gov/dmd. SCHEDULES Nomenclature: Controlled substances listed in these schedules are included by whatever official, common, usual, chemical, or trade name they may be designated. SCHEDULE I Schedule I consists of: -Schedule I opiates The following opiates, including their isomers, esters, ethers, salts, and salts of isomers, esters, and ethers, unless specifically excepted, if the existence of these isomers, esters, ethers, and salts are possible within the specific chemical designation: (1) Acetyl-α-methylfentanyl (N-[1-(1-methyl-2-phenethyl)-4-piperidinyl]-N- phenylacetamide); (2) Acetylmethadol; (3) Acetyl fentanyl (N-(1-phenethylpiperidin-4-yl)-N-phenylacetamide); (4) Acryl fentanyl (N-(1-phenethylpiperidin-4-yl)-N-phenylacrylamide) (Other name: -
1 441 702 B1
(19) TZZ__Z _T (11) EP 1 441 702 B1 (12) EUROPEAN PATENT SPECIFICATION (45) Date of publication and mention (51) Int Cl.: of the grant of the patent: A61K 31/4045 (2006.01) A61P 25/20 (2006.01) 10.05.2017 Bulletin 2017/19 A61K 9/20 (2006.01) (21) Application number: 02760523.7 (86) International application number: PCT/IL2002/000662 (22) Date of filing: 12.08.2002 (87) International publication number: WO 2003/015690 (27.02.2003 Gazette 2003/09) (54) METHOD FOR TREATING PRIMARY INSOMNIA VERFAHREN ZUR BEHANDLUNG PRIMÄRER INSOMNIA METHODE DE TRAITEMENT DE L’INSOMNIE PRIMAIRE (84) Designated Contracting States: • ROTH T ET AL: "Consensus for the AT BE BG CH CY CZ DE DK EE ES FI FR GB GR pharmacological management of insomnia in th IE IT LI LU MC NL PT SE SK TR enew millennium", INTERNATIONAL JOURNAL Designated Extension States: OF CLINICAL PRACTICE, MEDICON LT LV RO SI INTERNATIONAL, ESHER, GB, vol. 55, no. 1, 1 January 2001 (2001-01-01), page 10PAGES, (30) Priority: 14.08.2001 IL 14490001 XP002990688, ISSN: 1368-5031 • PERLIS M L ET AL: "Psychophysiological (43) Date of publication of application: insomnia: the behavioural model and a 04.08.2004 Bulletin 2004/32 neurocognitive perspective", JOURNAL OF SLEEP RESEARCH, BLACKWELL SCIENTIFIC, (60) Divisional application: OXFORD, GB, vol. 6, 1 January 1997 (1997-01-01), 16172415.8 / 3 103 443 pages 179-188, XP002990686, ISSN: 0962-1105, DOI: DOI:10.1046/J.1365-2869.1997.00045.X (73) Proprietor: NEURIM PHARMACEUTICALS (1991) • SILVA J A C E ET AL: "Special report from a LIMITED symposium held by the WHO and the World Tel Aviv 69710 (IL) Federation of sleep research societies: an overview of insomnias and related disorders - (72) Inventor: ZISAPEL, Nava recognition, epidemiology and rational 69355 Tel Aviv (IL) management", SLEEP, ALLEN PRESS, LAWRENCE, KS,US, vol. -
Appetite Suppressants and Pulmonary Hypertension
Thorax 1997;52(Suppl 3):S63±S67 S63 Thorax: first published as 10.1136/thx.52.2008.S63 on 1 August 1997. Downloaded from Appetite suppressants and pulmonary hypertension N F Voelkel Pulmonary Hypertension Center, University of Colorado Health Sciences Center, Denver, Colorado, USA Introductory article Appetite-suppressant drugs and the risk of primary pulmonary hypertension L Abenhaim, Y Moride, F Brenot, S Rich, J Binichou, X Kurz, T Higenbottam, C Oakley, E Wouters, M Aubier, G Simonneau, B Begaud for the International Primary Pulmonary Hypertension Study Group Background. Recently in France, primary pulmonary hypertension developed in a cluster of patients exposed to derivatives of fen¯uramine in appetite suppressants (anorexic agents), which are used for weight control. We investigated the potential role of anorexic agents and other suspected risk factors for primary pulmonary hypertension. Methods. In a case-control study, we assessed 95 patients with primary pulmonary hypertension from 35 centers in France, Belgium, the United Kingdom, and the Netherlands and 355 controls recruited from general practices and matched to the patients' sex and age. Results. The use of anorexic drugs (mainly derivatives of fen¯uramine) was associated with an increased risk of primary pulmonary hypertension (odds ratio with any anorexic-drug use, 6.3; 95 percent con®dence interval, 3.0 to 13.2). For the use of anorexic agents in the preceding year, the odds http://thorax.bmj.com/ ratio was 10.1 (95 percent con®dence interval, 3.4 to 29.9). When anorexic drugs were used for a total of more than three months, the odds ratio was 23.1 (95 percent con®dence interval, 6.9 to 77.7). -
Chapter 961 Uniform Controlled Substances Act
1 Updated 01−02 Wis. Stats. Database UNIFORM CONTROLLED SUBSTANCES ACT 961.01 CHAPTER 961 UNIFORM CONTROLLED SUBSTANCES ACT 961.001 Declaration of intent. 961.437 Possession and disposal of waste from manufacture of methamphetamine. SUBCHAPTER I 961.438 Minimum sentence. DEFINITIONS 961.44 Penalties under other laws. 961.01 Definitions. 961.45 Bar to prosecution. SUBCHAPTER II 961.455 Using a child for illegal drug distribution or manufacturing purposes. 961.46 Distribution to persons under age 18. STANDARDS AND SCHEDULES 961.465 Distribution to prisoners. 961.11 Authority to control. 961.47 Conditional discharge for possession or attempted possession as first of- 961.115 Native American Church exemption. fense. 961.12 Nomenclature. 961.472 Assessment; certain possession or attempted possession offenses. 961.13 Schedule I tests. 961.475 Treatment option. 961.14 Schedule I. 961.48 Second or subsequent offenses. 961.15 Schedule II tests. 961.49 Distribution of or possession with intent to deliver a controlled substance 961.16 Schedule II. on or near certain places. 961.17 Schedule III tests. 961.492 Distribution or possession with intent to deliver certain controlled sub- 961.18 Schedule III. stances on public transit vehicles. 961.19 Schedule IV tests. 961.495 Possession or attempted possession of a controlled substance on or near 961.20 Schedule IV. certain places. 961.21 Schedule V tests. 961.50 Suspension or revocation of operating privilege. 961.22 Schedule V. SUBCHAPTER V 961.23 Dispensing of schedule V substances. ENFORCEMENT AND ADMINISTRATIVE PROVISIONS 961.24 Publishing of updated schedules. 961.51 Powers of enforcement personnel. -
Laws 2021, LB236, § 4
LB236 LB236 2021 2021 LEGISLATIVE BILL 236 Approved by the Governor May 26, 2021 Introduced by Brewer, 43; Clements, 2; Erdman, 47; Slama, 1; Lindstrom, 18; Murman, 38; Halloran, 33; Hansen, B., 16; McDonnell, 5; Briese, 41; Lowe, 37; Groene, 42; Sanders, 45; Bostelman, 23; Albrecht, 17; Dorn, 30; Linehan, 39; Friesen, 34; Aguilar, 35; Gragert, 40; Kolterman, 24; Williams, 36; Brandt, 32. A BILL FOR AN ACT relating to law; to amend sections 28-1202 and 69-2436, Reissue Revised Statutes of Nebraska, and sections 28-401 and 28-405, Revised Statutes Cumulative Supplement, 2020; to redefine terms, change drug schedules, and adopt federal drug provisions under the Uniform Controlled Substances Act; to provide an exception to the offense of carrying a concealed weapon as prescribed; to define a term; to change provisions relating to renewal of a permit to carry a concealed handgun; to provide a duty for the Nebraska State Patrol; to eliminate an obsolete provision; to harmonize provisions; and to repeal the original sections. Be it enacted by the people of the State of Nebraska, Section 1. Section 28-401, Revised Statutes Cumulative Supplement, 2020, is amended to read: 28-401 As used in the Uniform Controlled Substances Act, unless the context otherwise requires: (1) Administer means to directly apply a controlled substance by injection, inhalation, ingestion, or any other means to the body of a patient or research subject; (2) Agent means an authorized person who acts on behalf of or at the direction of another person but does not include a common or contract carrier, public warehouse keeper, or employee of a carrier or warehouse keeper; (3) Administration means the Drug Enforcement Administration of the United States Department of Justice; (4) Controlled substance means a drug, biological, substance, or immediate precursor in Schedules I through V of section 28-405. -
21 CFR Ch. II (4–1–01 Edition) § 1308.11
§ 1308.11 21 CFR Ch. II (4–1–01 Edition) and on certain order forms issued by (4) Alphacetylmethadol (except levo- the Administration pursuant to alphacetylmethadol also known as levo-alpha- acetylmethadol, levomethadyl acetate, or LAAM) ..... 9603 § 1305.05(d) of this chapter. Applicants (5) Alphameprodine ....................................................... 9604 for procurement and/or individual man- (6) Alphamethadol ......................................................... 9605 ufacturing quotas must include the ap- (7) Alpha-methylfentanyl (N-[1-(alpha-methyl-beta- propriate code number on the applica- phenyl)ethyl-4-piperidyl] propionanilide; 1-(1-methyl- 2-phenylethyl)-4-(N-propanilido) piperidine) ............... 9814 tion as required in §§ 1303.12(b) and (8) Alpha-methylthiofentanyl (N-[1-methyl-2-(2- 1303.22(a) of this chapter. Applicants thienyl)ethyl-4-piperidinyl]-N-phenylpropanamide) ..... 9832 for import and export permits must in- (9) Benzethidine ............................................................. 9606 (10) Betacetylmethadol .................................................. 9607 clude the appropriate code number on (11) Beta-hydroxyfentanyl (N-[1-(2-hydroxy-2- the application as required in phenethyl)-4-piperidinyl]-N-phenylpropanamide) ....... 9830 §§ 1312.12(a) and 1312.22(a) of this chap- (12) Beta-hydroxy-3-methylfentanyl (other name: N-[1- ter. Authorized registrants who desire (2-hydroxy-2-phenethyl)-3-methyl-4-piperidinyl]-N- phenylpropanamide .................................................... 9831 -
House Bill 2356
House Engrossed State of Arizona House of Representatives Fiftieth Legislature Second Regular Session 2012 CHAPTER 1 HOUSE BILL 2356 AN ACT AMENDING SECTIONS 13-3401 AND 36-2515, ARIZONA REVISED STATUTES; RELATING TO DRUG OFFENSES. (TEXT OF BILL BEGINS ON NEXT PAGE) - i - H.B. 2356 1 Be it enacted by the Legislature of the State of Arizona: 2 Section 1. Section 13-3401, Arizona Revised Statutes, is amended to 3 read: 4 13-3401. Definitions 5 In this chapter, unless the context otherwise requires: 6 1. "Administer" means to apply, inject or facilitate the inhalation or 7 ingestion of a substance to the body of a person. 8 2. "Amidone" means any substance identified chemically as 9 (4-4-diphenyl-6-dimethylamine-heptanone-3), or any salt of such substance, by 10 whatever trade name designated. 11 3. "Board" means the Arizona state board of pharmacy. 12 4. "Cannabis" means the following substances under whatever names they 13 may be designated: 14 (a) The resin extracted from any part of a plant of the genus 15 cannabis, and every compound, manufacture, salt, derivative, mixture or 16 preparation of such plant, its seeds or its resin. Cannabis does not include 17 oil or cake made from the seeds of such plant, any fiber, compound, 18 manufacture, salt, derivative, mixture or preparation of the mature stalks of 19 such plant except the resin extracted from the stalks or any fiber, oil or 20 cake or the sterilized seed of such plant which is incapable of germination. 21 (b) Every compound, manufacture, salt, derivative, mixture or 22 preparation of such resin or tetrahydrocannabinol. -
Pharmaceuticals (Monocomponent Products) ………………………..………… 31 Pharmaceuticals (Combination and Group Products) ………………….……
DESA The Department of Economic and Social Affairs of the United Nations Secretariat is a vital interface between global and policies in the economic, social and environmental spheres and national action. The Department works in three main interlinked areas: (i) it compiles, generates and analyses a wide range of economic, social and environmental data and information on which States Members of the United Nations draw to review common problems and to take stock of policy options; (ii) it facilitates the negotiations of Member States in many intergovernmental bodies on joint courses of action to address ongoing or emerging global challenges; and (iii) it advises interested Governments on the ways and means of translating policy frameworks developed in United Nations conferences and summits into programmes at the country level and, through technical assistance, helps build national capacities. Note Symbols of United Nations documents are composed of the capital letters combined with figures. Mention of such a symbol indicates a reference to a United Nations document. Applications for the right to reproduce this work or parts thereof are welcomed and should be sent to the Secretary, United Nations Publications Board, United Nations Headquarters, New York, NY 10017, United States of America. Governments and governmental institutions may reproduce this work or parts thereof without permission, but are requested to inform the United Nations of such reproduction. UNITED NATIONS PUBLICATION Copyright @ United Nations, 2005 All rights reserved TABLE OF CONTENTS Introduction …………………………………………………………..……..……..….. 4 Alphabetical Listing of products ……..………………………………..….….…..….... 8 Classified Listing of products ………………………………………………………… 20 List of codes for countries, territories and areas ………………………...…….……… 30 PART I. REGULATORY INFORMATION Pharmaceuticals (monocomponent products) ………………………..………… 31 Pharmaceuticals (combination and group products) ………………….……........