Rupture – Autumn 2016 Edition
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510(K) SUBSTANTIAL EQUIVALENCE DETERMINATION CHECKLIST
510(k) SUBSTANTIAL EQUIVALENCE DETERMINATION DECISION SUMMARY ASSAY ONLY TEMPLATE A. 510(k) Number: k122633 B. Purpose for Submission: New device C. Measurand: d-Amphetamine, Secobarbital, Buprenorphine Glucuroide, Oxazepam, Benzoylecgonine, 3,4-methylenedioxymethamphetamine, Methamphetamine, Methadone, Moprhine, Oxycodone, Phencyclidine, Propoxyphene, Nortriptyline, 11-nor-∆9-Tetrahydrocannabinol- 9-carboxylic acid D. Type of Test: Qualitative lateral flow immunoassay E. Applicant: Branan Medical Corporation F. Proprietary and Established Names: ToxCup® Drug Screen Cup G. Regulatory Information: Product Classification Regulation Section Panel Code LDJ II 862.3870 Cannabinoid test system Toxicology (91) DIO II 862.3250 Cocaine and cocaine metabolite Toxicology (91) test system DJG II 862.3650 Opiate test system Toxicology (91) DJC II 862.3610 Methamphetamine test system Toxicology (91) DKZ II 862.3100 Amphetamine test system Toxicology (91) LCM unclassifed Enzyme immunoassay Phencyclidine Toxicology (91) JXM II 862.3170 Benzodiazepine test system Toxicology (91) DIS II 862.3150 Barbiturate test system Toxicology (91) DJR II 862.3620 Methadone test system Toxicology (91) LFG II 862.3910 Tricyclic antidepressant drugs Toxicology (91) test system JXN II 862.3700 Propoxyphene test system Toxicology (91) H. Intended Use: 1. Intended use(s): See indications for use below. 2. Indications(s) for use: The ToxCup Drug Screen Cup is an in vitro screening test for the rapid detection of multiple drugs and drug metabolites in human urine at or above -
The Alkaloids: Chemistry and Biology
CONTRIBUTORS Numbers in parentheses indicate the pages on which the authors’ contributions begin. B. EMMANUEL AKINSHOLA (135), Department of Pharmacology, College of Medicine, Howard University, Washington, DC 20059, eakinshola@ howard.edu NORMA E. ALEXANDER (293), NDA International, 46 Oxford Place, Staten Island, NY 10301, [email protected] SYED F. ALI (79, 135), Division of Neurotoxicology, National Center for Toxicological Research, 3900 NCTR Road, Jefferson, AR 72079, [email protected] KENNETH R. ALPER (1, 249), Departments of Psychiatry and Neurology, New York University School of Medicine, 550 First Avenue, New York, NY 10016, [email protected] MICHAEL H. BAUMANN (79), Clinical Psychopharmacology Section, Intra- mural Research Program, NIDA, National Institutes of Health, Baltimore, MD 21224, [email protected] DANA BEAL (249), Cures-not-Wars, 9 Bleecker Street, New York, NY 10012, [email protected] ZBIGNIEW K. BINIENDA (193), Division of Neurotoxicology, National Cen- ter for Toxicological Research, 3900 NCTR Road, Jefferson, AR 72079, [email protected] WAYNE D. BOWEN (173), Laboratory of Medicinal Chemistry, NIDDK, NIH, Building 8 B1-23, 8 Center Drive, MSC 0820, Bethesda, MD 20892, [email protected] FRANK R. ERVIN (155), Department of Psychiatry and Human Genetics, McGill University, Montreal, Quebec H3A 2T5, Canada, md18@musica. mcgill.ca JAMES W. FERNANDEZ (235), Department of Anthropology, University of Chicago, 1126 E. 59th Street, Chicago, IL 60637, jwfi@midway. uchicago.edu xi xii CONTRIBUTORS RENATE L. FERNANDEZ (235), Department of Anthropology, University of Chicago, 1126 E. 59th Street, Chicago, IL 60637, rlf2@midway. uchicago.edu GEERTE FRENKEN (283), INTASH, P.O. -
Tinnitus Hopes Put to Sleep by Latest Auris Failure
March 14, 2018 Tinnitus hopes put to sleep by latest Auris failure Madeleine Armstrong Ketamine is best known as a horse tranquiliser or a recreational drug, but it has also been proposed as a treatment for various disorders from depression to Alzheimer’s. Hopes of developing the drug in tinnitus have been dashed by the failure of Auris’s Keyzilen in a second phase III trial. As well as leaving Auris’s future looking bleak – Keyzilen is the second of its phase III candidates to flunk in four months – the setback could also be bad news for the sparse tinnitus pipeline. According to EvaluatePharma there is only one other candidate in active clinical development, Otonomy’s OTO-313, and this uses the same mechanism of action as Keyzilen (see table below). Tinnitus pipeline Generic Project Company Pharma class Trial(s) Notes name Phase III Auris Esketamine TACTT2 Keyzilen NMDA antagonist Failed Aug 2016 Medical hydrochloride (NCT01803646) TACTT3 Failed Mar 2018 (NCT02040194) Phase I OTO- Phase I/II trial to OTO-311 abandoned in Otonomy NMDA antagonist Gacyclidine 313 start H1 2019 favour of this formulation Preclinical Auris AM-102 Undisclosed - - Medical KCNQ2 Knopp Kv7 potassium - - Program Biosciences channel modulator Source: EvaluatePharma. Both projects are psychoactive drugs targeting the NMDA receptor. Tinnitus is commonly caused by loud noise and resulting damage to the sensory hair cells in the cochlea. Initial trauma to the inner ear has been shown to trigger excess production of glutamate, which leads to the hyperactivation of NMDA receptors and, in turn, cell death. Blocking the NMDA receptor could therefore have a protective effect – but it is unclear how this mechanism would work once the damage to hair cells had been done. -
(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. -
Characterization of Multiple Sites of Action of Ibogaine
——Chapter 6—— CHARACTERIZATION OF MULTIPLE SITES OF ACTION OF IBOGAINE Henry Sershen, Audrey Hashim, And Abel Lajtha Nathan Kline Institute Orangeburg, New York 10962 I. Introduction.................................................................................................................. II. Issues Related to Ibogaine in the Treatment of Drug Dependence............................. A. Dopamine as a Primary Site of Drug-Mediated Responses .................................. B. Ibogaine or Its Metabolite and Acute versus Long-Term Effect........................... C. Single or Multiple Sites of Action of Ibogaine ..................................................... III. Effect of Ibogaine on Drug-Induced Behavior............................................................ IV. Binding Site Activity ................................................................................................... A. Relevant Site of Action.......................................................................................... V. Functional Activity ...................................................................................................... VI. Stimulant Drug Actions/Behaviors.............................................................................. VII. Current Non-Ibogaine Drug Treatment Protocols ....................................................... VIII. Conclusions.................................................................................................................. References................................................................................................................... -
Salicylate Induces Tinnitus Through Activation of Cochlear NMDA Receptors
3944 • The Journal of Neuroscience, May 1, 2003 • 23(9):3944–3952 Salicylate Induces Tinnitus through Activation of Cochlear NMDA Receptors Matthieu J. Guitton,1 Jean Caston,2 Je´roˆme Ruel,1 Randolph M. Johnson,3 Re´my Pujol,1 and Jean-Luc Puel1 1Institut National de la Sante´ et de la Recherche Me´dicale UR-254, Laboratoire de Neurobiologie de l’Audition–Plasticite´ Synaptique, Faculte´deMe´decine, Universite´ de Montpellier 1, 34090 Montpellier, France, 2 Unite´ Propre de Recherche et de l’Enseignement Supe´rieur 1780, Laboratoire de Neurobiologie de l’Apprentissage, Universite´ de Rouen, 76821 Mont-Saint-Aignan, France, and 3DURECT Corporation, Cupertino, California 95014 Salicylate, the active component of aspirin, is known to induce tinnitus. However, the site and the mechanism of generation of tinnitus induced by salicylate remains unclear. Here, we developed a behavioral procedure to measure tinnitus in rats. The behavioral model was based on an active avoidance paradigm in which rats had to display a motor task (i.e., to jump on a climbing pole when hearing a sound). Giving salicylate led to a decrease in the percentage of correct responses (score) and a drastic increase in the number of false positive responses (i.e., animals execute the motor task during a silent period). Presentation of the sound at a constant perceptive level prevents decrease of the score, leading to the proposal that score is related to hearing performance. In contrast, the increase of false positive responses remained unchanged. In fact, animals behaved as if they hear a sound, indicating that they are experiencing tinnitus. -
Customs Tariff - Schedule
CUSTOMS TARIFF - SCHEDULE 99 - i Chapter 99 SPECIAL CLASSIFICATION PROVISIONS - COMMERCIAL Notes. 1. The provisions of this Chapter are not subject to the rule of specificity in General Interpretative Rule 3 (a). 2. Goods which may be classified under the provisions of Chapter 99, if also eligible for classification under the provisions of Chapter 98, shall be classified in Chapter 98. 3. Goods may be classified under a tariff item in this Chapter and be entitled to the Most-Favoured-Nation Tariff or a preferential tariff rate of customs duty under this Chapter that applies to those goods according to the tariff treatment applicable to their country of origin only after classification under a tariff item in Chapters 1 to 97 has been determined and the conditions of any Chapter 99 provision and any applicable regulations or orders in relation thereto have been met. 4. The words and expressions used in this Chapter have the same meaning as in Chapters 1 to 97. Issued January 1, 2020 99 - 1 CUSTOMS TARIFF - SCHEDULE Tariff Unit of MFN Applicable SS Description of Goods Item Meas. Tariff Preferential Tariffs 9901.00.00 Articles and materials for use in the manufacture or repair of the Free CCCT, LDCT, GPT, UST, following to be employed in commercial fishing or the commercial MT, MUST, CIAT, CT, harvesting of marine plants: CRT, IT, NT, SLT, PT, COLT, JT, PAT, HNT, Artificial bait; KRT, CEUT, UAT, CPTPT: Free Carapace measures; Cordage, fishing lines (including marlines), rope and twine, of a circumference not exceeding 38 mm; Devices for keeping nets open; Fish hooks; Fishing nets and netting; Jiggers; Line floats; Lobster traps; Lures; Marker buoys of any material excluding wood; Net floats; Scallop drag nets; Spat collectors and collector holders; Swivels. -
CAS Number Index
2334 CAS Number Index CAS # Page Name CAS # Page Name CAS # Page Name 50-00-0 905 Formaldehyde 56-81-5 967 Glycerol 61-90-5 1135 Leucine 50-02-2 596 Dexamethasone 56-85-9 963 Glutamine 62-44-2 1640 Phenacetin 50-06-6 1654 Phenobarbital 57-00-1 514 Creatine 62-46-4 1166 α-Lipoic acid 50-11-3 1288 Metharbital 57-22-7 2229 Vincristine 62-53-3 131 Aniline 50-12-4 1245 Mephenytoin 57-24-9 1950 Strychnine 62-73-7 626 Dichlorvos 50-23-7 1017 Hydrocortisone 57-27-2 1428 Morphine 63-05-8 127 Androstenedione 50-24-8 1739 Prednisolone 57-41-0 1672 Phenytoin 63-25-2 335 Carbaryl 50-29-3 569 DDT 57-42-1 1239 Meperidine 63-75-2 142 Arecoline 50-33-9 1666 Phenylbutazone 57-43-2 108 Amobarbital 64-04-0 1648 Phenethylamine 50-34-0 1770 Propantheline bromide 57-44-3 191 Barbital 64-13-1 1308 p-Methoxyamphetamine 50-35-1 2054 Thalidomide 57-47-6 1683 Physostigmine 64-17-5 784 Ethanol 50-36-2 497 Cocaine 57-53-4 1249 Meprobamate 64-18-6 909 Formic acid 50-37-3 1197 Lysergic acid diethylamide 57-55-6 1782 Propylene glycol 64-77-7 2104 Tolbutamide 50-44-2 1253 6-Mercaptopurine 57-66-9 1751 Probenecid 64-86-8 506 Colchicine 50-47-5 589 Desipramine 57-74-9 398 Chlordane 65-23-6 1802 Pyridoxine 50-48-6 103 Amitriptyline 57-92-1 1947 Streptomycin 65-29-2 931 Gallamine 50-49-7 1053 Imipramine 57-94-3 2179 Tubocurarine chloride 65-45-2 1888 Salicylamide 50-52-2 2071 Thioridazine 57-96-5 1966 Sulfinpyrazone 65-49-6 98 p-Aminosalicylic acid 50-53-3 426 Chlorpromazine 58-00-4 138 Apomorphine 66-76-2 632 Dicumarol 50-55-5 1841 Reserpine 58-05-9 1136 Leucovorin 66-79-5 -
Effects of Sustained Phencyclidine Exposure on Sensorimotor Gating of Startle in Rats Zoë A
Effects of Sustained Phencyclidine Exposure on Sensorimotor Gating of Startle in Rats Zoë A. Martinez, M.A., Gaylord D. Ellison, Ph.D, Mark A. Geyer, Ph.D, and Neal R. Swerdlow, M.D., Ph.D Phencyclidine (PCP), a non-competitive NMDA which parallels the decrease observed in schizophrenia antagonist with actions at multiple other central nervous patients. In the present study, we examined changes in PPI system receptors, can cause both acute and lasting during and after sustained PCP administration, using psychoses in humans, and has also been used in cross- 5-day PCP exposure via subcutaneous osmotic minipumps, species models of psychosis. Acute exposure to PCP in rats or 14-day PCP exposure via repeated intraperitoneal produces behavioral changes, including a loss of prepulse injections. In both forms of drug delivery, PPI was inhibition (PPI) of the startle reflex, which parallels the loss disrupted during, but not after, sustained drug exposure. of PPI observed in schizophrenia patients. Sustained PPI does not appear to be sensitive to neuropathological exposure to PCP in rats produces neuropathological effects of sustained PCP exposure. changes in several limbic regions and prolonged behavioral [Neuropsychopharmacology 21:28–39, 1999] abnormalities that may parallel neuropsychological deficits © 1999 American College of Neuropsychopharmacology. in schizophrenia. It is unclear whether sustained PCP Published by Elsevier Science Inc. exposure will also produce a loss of prepulse inhibition KEY WORDS: Apomorphine; Phencyclidine; Prepulse schizophrenia is demonstrated by the significant corre- inhibition; Schizophrenia; Sensorimotor; Startle lation between PPI and measures of thought disorder (Perry and Braff 1994) and positive and negative symp- Schizophrenia patients demonstrate abnormalities in toms (Braff et al. -
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. -
Drugs of Abuseon September Archived 13-10048 No
U.S. DEPARTMENT OF JUSTICE DRUG ENFORCEMENT ADMINISTRATION WWW.DEA.GOV 9, 2014 on September archived 13-10048 No. v. Stewart, in U.S. cited Drugs of2011 Abuse EDITION A DEA RESOURCE GUIDE V. Narcotics WHAT ARE NARCOTICS? Also known as “opioids,” the term "narcotic" comes from the Greek word for “stupor” and originally referred to a variety of substances that dulled the senses and relieved pain. Though some people still refer to all drugs as “narcot- ics,” today “narcotic” refers to opium, opium derivatives, and their semi-synthetic substitutes. A more current term for these drugs, with less uncertainty regarding its meaning, is “opioid.” Examples include the illicit drug heroin and pharmaceutical drugs like OxyContin®, Vicodin®, codeine, morphine, methadone and fentanyl. WHAT IS THEIR ORIGIN? The poppy papaver somniferum is the source for all natural opioids, whereas synthetic opioids are made entirely in a lab and include meperidine, fentanyl, and methadone. Semi-synthetic opioids are synthesized from naturally occurring opium products, such as morphine and codeine, and include heroin, oxycodone, hydrocodone, and hydromorphone. Teens can obtain narcotics from friends, family members, medicine cabinets, pharmacies, nursing 2014 homes, hospitals, hospices, doctors, and the Internet. 9, on September archived 13-10048 No. v. Stewart, in U.S. cited What are common street names? Street names for various narcotics/opioids include: ➔ Hillbilly Heroin, Lean or Purple Drank, OC, Ox, Oxy, Oxycotton, Sippin Syrup What are their forms? Narcotics/opioids come in various forms including: ➔ T ablets, capsules, skin patches, powder, chunks in varying colors (from white to shades of brown and black), liquid form for oral use and injection, syrups, suppositories, lollipops How are they abused? ➔ Narcotics/opioids can be swallowed, smoked, sniffed, or injected. -
Advisory Council on the Misuse of Drugs Chair: Professor Les Iversen Secretary: Rachel Fowler 3Rd Floor Seacole Building 2
ACMD Advisory Council on the Misuse of Drugs Chair: Professor Les Iversen Secretary: Rachel Fowler 3rd Floor Seacole Building 2. Marsham Street London SW1P 4DF 020 7035 0454 Email: [email protected] Rt Hon. Theresa May MP Home Office 2 Marsham Street London SW1P 4DF 18th October 2012 Dear Home Secretary, In March 2012 the ACMD advised that methoxetamine be subject to a temporary class drug order. Methoxetamine was marketed as a legal alternative to ketamine until a temporary class drug order was implemented in April 2012. As is now required, the ACMD has followed its initial assessment with a consideration of methoxetamine in the context of the Misuse of Drugs Act 1971; I enclose the report with this letter. The chemical structure of methoxetamine bears a close resemblance to that of both ketamine and phencyclidine (PCP, „Angel Dust‟, a class A drug), which both produce well- documented and serious adverse effects following both acute and chronic usage. Users report that the effects of methoxetamine are similar to those of ketamine, however, some users report that the effects are of longer duration.The harmful effects reported include severe dissociation, cardiovascular symptoms, paranoid thoughts and unpleasant hallucinations. The first analytically confirmed series reported by Guy‟s and St Thomas‟ NHS Foundation Trust, London in 2011, was of three individuals who presented having self-reported use of methoxetamine. All three presented with a ketamine-like dissociative state, but also had significant stimulant effects with agitation and cardiovascular effects including tachycardia and hypertension. Toxicological screening of serum samples confirmed methoxetamine use in two of the cases.