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Clinical Experience in Schizophrenia: a Neuromedicine New Option to Address Unmet Needs
Bhat L, Cantillon M, Ings R. Brilaroxazine (RP5063) Clinical Experience in Schizophrenia: A Neuromedicine New Option to Address Unmet Needs. J Neurol Neuromedicine (2018) 3(5): 39-50 www.jneurology.com www.jneurology.com Journal of Neurology && NeuromedicineNeuromedicine Review Article Open Access Brilaroxazine (RP5063) Clinical Experience in Schizophrenia: A New Option to Address Unmet Needs Laxminarayan Bhat*, Marc Cantillon, and Robert Ings Reviva Pharmaceuticals, Inc., Sunnyvale, CA, USA Article Info ABSTRACT Article Notes Schizophrenia is a condition comprising of both treatment and comorbidity Received: September 18, 2018 factors that both complicate its management and present multiple unmet needs. Accepted: October 22, 2018 Brilaroxazine (RP5063), a dopamine (D)/serotonin (5-HT) modulator, possesses in vitro *Correspondence: a broad pharmacology profile against D2/3/4 and 5-HT1A/2A/2B/6/7 receptors, Dr. Laxminarayan Bhat, 1250 Oakmead Parkway, Suite 210, nicotinic acetylcholine (α4β2) receptors, and the serotonin transporter. In Phase 1 Sunnyvale, CA 94085, USA; Telephone No. +1 (408) 816 1454; and 2 clinical experience in healthy volunteers, patients with schizophrenia and Fax No. +1 (408) 904 6270; ORCID Number: 0000-0003-0503- schizoaffective disorder, brilaroxazine was well tolerated, with the repeated 100 mg 8537; Email: [email protected]. oral dose as the maximum tolerated dose. Investigators observed no cardiometabolic, cardiovascular, prolactin, or neurologic complications. Adherence in Phase 2 was © 2018 Bhat L. This article is distributed under the terms of the Creative Commons Attribution 4.0 International License good with discontinuation rates generally less than placebo. In a Phase 2 evaluation of patients with acute exacerbations in schizophrenia and schizoaffective disorders, brilaroxazine met its primary endpoint of significance versus placebo for Total Positive and Negative Symptom Scale (PANSS) Score at Day 28 as compared to baseline. -
What Are the Acute Treatments for Migraine and How Are They Used?
2. Acute Treatment CQ II-2-1 What are the acute treatments for migraine and how are they used? Recommendation The mainstay of acute treatment for migraine is pharmacotherapy. The drugs used include (1) acetaminophen, (2) non-steroidal anti-inflammatory drugs (NSAIDs), (3) ergotamines, (4) triptans and (5) antiemetics. Stratified treatment according to the severity of migraine is recommended: use NSAIDs such as aspirin and naproxen for mild to moderate headache, and use triptans for moderate to severe headache, or even mild to moderate headache when NSAIDs were ineffective in the past. It is necessary to give guidance and cautions to patients having acute attacks, and explain the methods of using medications (timing, dose, frequency of use) and medication use during pregnancy and breast-feeding. Grade A Background and Objective The objective of acute treatment is to resolve the migraine attack completely and rapidly and restore the patient’s normal functions. An ideal treatment should have the following characteristics: (1) resolves pain and associated symptoms rapidly; (2) is consistently effective; (3) no recurrence; (4) no need for additional use of medication; (5) no adverse effects; (6) can be administered by the patients themselves; and (7) low cost. Literature was searched to identify acute treatments that satisfy the above conditions. Comments and Evidence The acute treatment drugs for migraine generally include (1) acetaminophens, (2) non-steroidal anti-inflammatory drugs (NSAIDs), (3) ergotamines, (4) triptans, and (5) antiemetics. For severe migraines including status migrainosus and migraine attacks refractory to treatment, (6) anesthetics, and (7) corticosteroids (dexamethasone) are used (Tables 1 and 2).1)-9) There are two approaches to the selection and sequencing of these medications: “step care” and “stratified care”. -
Calcium Channel Blocker As a Drug Candidate for the Treatment of Generalised Epilepsies
UNIVERSITAT DE BARCELONA Faculty of Pharmacy and Food Sciences Calcium channel blocker as a drug candidate for the treatment of generalised epilepsies Final degree project Author: Janire Sanz Sevilla Bachelor's degree in Pharmacy Primary field: Organic Chemistry, Pharmacology and Therapeutics Secondary field: Physiology, Pathophysiology and Molecular Biology March 2019 This work is licensed under a Creative Commons license ABBREVIATIONS AED antiepileptic drug AMPA α-amino-3-hydroxy-5-methyl-4-isoxazolepropionic acid ANNA-1 antineuronal nuclear antibody 1 BBB blood-brain barrier Bn benzyl BnBr benzyl bromide BnNCO benzyl isocyanate Boc tert-butoxycarbonyl Bu4NBr tetrabutylammonium bromide Ca+2 calcium ion CACNA1 calcium channel voltage-dependent gene cAMP cyclic adenosine monophosphate CCB calcium channel blocker cGMP cyclic guanosine monophosphate CH3CN acetonitrile Cl- chlorine ion Cmax maximum concentration CMV cytomegalovirus CTScan computed axial tomography DCM dichloromethane DIPEA N,N-diisopropylethylamine DMF dimethylformamide DMPK drug metabolism and pharmacokinetics DNET dysembryoplastic neuroepithelial tumours EEG electroencephalogram EPSP excitatory post-synaptic potential FDA food and drug administration Fe iron FLIPR fluorescence imaging plate reader fMRI functional magnetic resonance imaging GABA γ-amino-α-hydroxybutyric acid GAD65 glutamic acid decarboxylase 65 GAERS generalised absence epilepsy rat of Strasbourg GluR5 kainate receptor GTC generalised tonic-clonic H+ hydrogen ion H2 hydrogen H2O dihydrogen dioxide (water) -
Chronic Olanzapine Or Sertindole Treatment Results in Reduced Oral Chewing Movements in Rats Compared to Haloperidol Xue-Min Gao, M.D., Kazuo Sakai, M.D., and Carol A
Chronic Olanzapine or Sertindole Treatment Results in Reduced Oral Chewing Movements in Rats Compared to Haloperidol Xue-Min Gao, M.D., Kazuo Sakai, M.D., and Carol A. Tamminga, M.D. Chronic haloperidol treatment typically produces late-onset, haloperidol-like chewing in rats, nor did movement ratings purposeless oral chewing movements in laboratory rats with after their chronic administration differ from placebo; a prevalence of 40 to 60%. Chronic clozapine does not whereas, haloperidol produced a 60% prevalence of produce these movements. Based on the phenomenologic purposeless chewing and a prevalence significantly and pharmacologic similarities between these rat chewing increased from placebo. This low rate of oral dyskinesias in movements and human tardive dyskinesia (TD), the animal rats is consistent with several of the preclinical movements are often used as a model of tardive dyskinesia characteristics of the drugs and correlates with their low (TD). Here we report results of the association of oral acute motor side effects in clinical trials. We propose, chewing movements in rats with chronic administration of although have not yet tested in humans, that these animal two new antipsychotic drugs, olanzapine and sertindole. results will predict low TD liability of these drugs. Because each of these antipsychotic drugs has a very low [Neuropsychopharmacology 19:428–433, 1998] incidence of acute Parkinsonism in human studies, they are © 1998 American College of Neuropsychopharmacology. candidates for showing a low tardive dyskinesia risk. Published by Elsevier Science Inc. Neither new drug produced a significant incidence of KEY WORDS: Dyskinesia; Olanzapine; Sertindole; movements parallel certain features (although not all) Haloperidol; Tardive dyskinesia; Chronic neuroleptic of the human neuroleptic-induced dyskinetic syndrome treatment tardive dyskinesia (TD), they are often used in its study. -
Drugs That Can Cause Delirium (Anticholinergic / Toxic Metabolites)
Drugs that can Cause Delirium (anticholinergic / toxic metabolites) Deliriants (drugs causing delirium) Prescription drugs . Central acting agents – Sedative hypnotics (e.g., benzodiazepines) – Anticonvulsants (e.g., barbiturates) – Antiparkinsonian agents (e.g., benztropine, trihexyphenidyl) . Analgesics – Narcotics (NB. meperidine*) – Non-steroidal anti-inflammatory drugs* . Antihistamines (first generation, e.g., hydroxyzine) . Gastrointestinal agents – Antispasmodics – H2-blockers* . Antinauseants – Scopolamine – Dimenhydrinate . Antibiotics – Fluoroquinolones* . Psychotropic medications – Tricyclic antidepressants – Lithium* . Cardiac medications – Antiarrhythmics – Digitalis* – Antihypertensives (b-blockers, methyldopa) . Miscellaneous – Skeletal muscle relaxants – Steroids Over the counter medications and complementary/alternative medications . Antihistamines (NB. first generation) – diphenhydramine, chlorpheniramine). Antinauseants – dimenhydrinate, scopolamine . Liquid medications containing alcohol . Mandrake . Henbane . Jimson weed . Atropa belladonna extract * Requires adjustment in renal impairment. From: K Alagiakrishnan, C A Wiens. (2004). An approach to drug induced delirium in the elderly. Postgrad Med J, 80, 388–393. Delirium in the Older Person: A Medical Emergency. Island Health www.viha.ca/mhas/resources/delirium/ Drugs that can cause delirium. Reviewed: 8-2014 Some commonly used medications with moderate to high anticholinergic properties and alternative suggestions Type of medication Alternatives with less deliriogenic -
PRODUCT MONOGRAPH ELAVIL® Amitriptyline Hydrochloride Tablets
PRODUCT MONOGRAPH ELAVIL® amitriptyline hydrochloride tablets USP 10, 25, 50 and 75 mg Antidepressant AA PHARMA INC. DATE OF PREPARATION: 1165 Creditstone Road Unit #1 August 29, 2018 Vaughan, ON L4K 4N7 Control No.: 217626 1 PRODUCT MONOGRAPH ELAVIL® amitriptyline hydrochloride tablets USP 10, 25, 50, 75 mg THERAPEUTIC CLASSIFICATION Antidepressant ACTIONS AND CLINICAL PHARMACOLOGY Amitriptyline hydrochloride is a tricyclic antidepressant with sedative properties. Its mechanism of action in man is not known. Amitriptyline inhibits the membrane pump mechanism responsible for the re-uptake of transmitter amines, such as norepinephrine and serotonin, thereby increasing their concentration at the synaptic clefts of the brain. Amitriptyline has pronounced anticholinergic properties and produces EKG changes and quinidine-like effects on the heart (See ADVERSE REACTIONS). It also lowers the convulsive threshold and causes alterations in EEG and sleep patterns. Orally administered amitriptyline is readily absorbed and rapidly metabolized. Steady-state plasma concentrations vary widely and this variation may be genetically determined. Amitriptyline is primarily excreted in the urine, mostly in the form of metabolites, with some excretion also occurring in the feces. INDICATIONS AND CLINICAL USE ELAVIL® (amitriptyline hydrochloride) is indicated in the drug management of depressive illness. ELAVIL® may be used in depressive illness of psychotic or endogenous nature and in selected patients with neurotic depression. Endogenous depression is more likely to be alleviated than are other depressive states. ELAVIL® ®, because of its sedative action, is also of value in alleviating the anxiety component of depression. As with other tricyclic antidepressants, ELAVIL® may precipitate hypomanic episodes in patients with bipolar depression. These drugs are not indicated in mild depressive states and depressive reactions. -
Cabergoline Patient Handout
Cabergoline For the Patient: Cabergoline Other names: DOSTINEX® • Cabergoline (ca-BERG-go-leen) is used to treat cancers that cause the body to produce too much of a hormone called prolactin. Cabergoline helps decrease the size of the cancer and the production of prolactin. It is a tablet that you take by mouth. • Tell your doctor if you have ever had an unusual or allergic reaction to bromocriptine or other ergot derivatives, such as pergoline (PERMAX®) and methysergide (SANSERT®), before taking cabergoline. • Blood tests and blood pressure measurement may be taken while you are taking cabergoline. The dose of cabergoline may be changed based on the test results and/or other side effects. • It is important to take cabergoline exactly as directed by your doctor. Make sure you understand the directions. Take cabergoline with food. • If you miss a dose of cabergoline, take it as soon as you can if it is within 2 days of the missed dose. If it is over 2 days since your missed dose, skip the missed dose and go back to your usual dosing times. • Other drugs such as azithromycin (ZITHROMAX®), clarithromycin (BIAXIN®), erythromycin, domperidone, metoclopramide, and some drugs used to treat mental or mood problems may interact with cabergoline. Tell your doctor if you are taking these or any other drugs as you may need extra blood tests or your dose may need to be changed. Check with your doctor or pharmacist before you start or stop taking any other drugs. • The drinking of alcohol (in small amounts) does not appear to affect the safety or usefulness of cabergoline. -
PRESCRIBED DRUGS and NEUROLOGICAL COMPLICATIONS K a Grosset, D G Grosset Iii2
J Neurol Neurosurg Psychiatry: first published as 10.1136/jnnp.2004.045757 on 16 August 2004. Downloaded from PRESCRIBED DRUGS AND NEUROLOGICAL COMPLICATIONS K A Grosset, D G Grosset iii2 J Neurol Neurosurg Psychiatry 2004;75(Suppl III):iii2–iii8. doi: 10.1136/jnnp.2004.045757 treatment history is a fundamental part of the healthcare consultation. Current drugs (prescribed, over the counter, herbal remedies, drugs of misuse) and how they are taken A(frequency, timing, missed and extra doses), drugs tried previously and reason for discontinuation, treatment response, adverse effects, allergies, and intolerances should be taken into account. Recent immunisations may also be of importance. This article examines the particular relevance of medication in patients presenting with neurological symptoms. Drugs and their interactions may contribute in part or fully to the neurological syndrome, and treatment response may assist diagnostically or in future management plans. Knowledge of medicine taking behaviour may clarify clinical presentations such as analgesic overuse causing chronic daily headache, or severe dyskinesia resulting from obsessive use of dopamine replacement treatment. In most cases, iatrogenic symptoms are best managed by withdrawal of the offending drug. Indirect mechanisms whereby drugs could cause neurological problems are beyond the scope of the current article—for example, drugs which raise blood pressure or which worsen glycaemic control and consequently increase the risk of cerebrovascular disease, or immunosupressants -
Antipsychotics
© Copyright 2012 Oregon State University. All Rights Reserved Drug Use Research & Management Program Oregon State University, 500 Summer Street NE, E35 Salem, Oregon 97301-1079 Phone 503-947-5220 | Fax 503-947-1119 Class Update with New Drug Evaluations: Antipsychotics Date of Review: May 2016 End Date of Literature Search: February 2016 New Drugs: brexpiprazole Brand Names (Manufacturer): Rexulti® (Otsuka) cariprazine Vraylar™ (Actavis) Dossiers Received: yes PDL Classes: Antipsychotics, First generation Antipsychotics, Second generation Antipsychotics, Parenteral Current Status of PDL Class: See Appendix 1. Purpose for Class Update: Several new antipsychotic drug products have been approved by the U.S. Food and Drug Administration since these drug classes were last reviewed by the Oregon Health Plan (OHP) Pharmacy and Therapeutics Committee. Research Questions: 1. Is there new comparative evidence of meaningful difference in efficacy or effectiveness outcomes for schizophrenia, bipolar mania or major depressive disorders (MDD) between oral antipsychotic agents (first‐ or second‐generation) or between parenteral antipsychotic agents (first‐ or second‐generation)? 2. Is there new comparative evidence of meaningful difference in harms between oral antipsychotic agents (first‐ or second‐generation) or between parenteral antipsychotic agents (first‐ or second‐generation)? 3. Is there new comparative evidence of meaningful difference in effectiveness or harms in certain subpopulations based on demographic characteristics? Conclusions: There is insufficient evidence of clinically meaningful differences between antipsychotic agents in efficacy or effectiveness or harms between antipsychotic agents for schizophrenia, bipolar mania or MDD. There is insufficient evidence to determine if brexpiprazole and cariprazine offer superior efficacy or safety to other antipsychotic agents for schizophrenia. There is insufficient evidence to determine if brexpiprazole offers superior efficacy or safety to other antipsychotic agents for MDD. -
Uva-DARE (Digital Academic Repository)
UvA-DARE (Digital Academic Repository) Venous and arterial coronary artery bypass grafts in a pharmacological perspective Rinia-Feenstra, M. Publication date 2001 Link to publication Citation for published version (APA): Rinia-Feenstra, M. (2001). Venous and arterial coronary artery bypass grafts in a pharmacological perspective. General rights It is not permitted to download or to forward/distribute the text or part of it without the consent of the author(s) and/or copyright holder(s), other than for strictly personal, individual use, unless the work is under an open content license (like Creative Commons). Disclaimer/Complaints regulations If you believe that digital publication of certain material infringes any of your rights or (privacy) interests, please let the Library know, stating your reasons. In case of a legitimate complaint, the Library will make the material inaccessible and/or remove it from the website. Please Ask the Library: https://uba.uva.nl/en/contact, or a letter to: Library of the University of Amsterdam, Secretariat, Singel 425, 1012 WP Amsterdam, The Netherlands. You will be contacted as soon as possible. UvA-DARE is a service provided by the library of the University of Amsterdam (https://dare.uva.nl) Download date:04 Oct 2021 92 Saphenous vein harvesting techniques 15. Zerkowski H-R, Knocks M, Konerding MA, et al. Endothelial damage of the venous graft in CABG. Eur] Cardiothorac Surg 1993;7:376-82. 16. Dhein S, Reiß N, Gerwin R, et al. Endothelial function and contractility of human vena saphena magna prepared for aortocoronary bypass grafting. Thorac Cardiovasc Surg 1991;39:66-9. -
The Metabolic Side Effects of 12 Antipsychotic Drugs Used for The
Zhang et al. BMC Psychiatry (2017) 17:373 DOI 10.1186/s12888-017-1539-0 RESEARCHARTICLE Open Access The metabolic side effects of 12 antipsychotic drugs used for the treatment of schizophrenia on glucose: a network meta-analysis Yangyu Zhang†, Yingyu Liu†, Yingying Su, Yueyue You, Yue Ma, Guang Yang, Yan Song, Xinyu Liu, Mohan Wang, Lili Zhang and Changgui Kou* Abstract Background: Antipsychotics have serious metabolic side effects on blood glucose. However, the comparative influence of these drugs on blood glucose levels has not been comprehensively evaluated. We conducted a network meta-analysis to create a hierarchy of the side effects of 12 antipsychotic drugs on changes in blood glucose levels. Methods: A systematic search of the PubMed, EMBASE and Cochrane databases (last search June 2016) was conducted to identify studies that reported randomized controlled trials (RCTs) comparing changes in blood glucose levels between patients receiving one of 12 antipsychotic drugs or a placebo for the treatment of schizophrenia or related disorders. The studies we searched were limited to those published in English. Two reviewers independently extracted data. The primary outcome of interest was changes in fasting glucose levels. Results: We included 47 studies with 114 relevant arms. Of the antipsychotic drugs, only olanzapine was associated with significantly increased glucose levels compared to a placebo (mean difference (MD) = 3.95, 95% confidence interval (CI) = 0.14 to 7.76). Moreover, olanzapine was associated with a significantly greater change in the glucose levels than ziprasidone (MD = 5.51, 95% CI = 1.62 to 9.39), lurasidone (MD = 5.58, 95% CI = 0.53 to 10.64) or risperidone (MD = 3.05, 95% CI = 0.87 to 5.22). -
United States Patent (10 ) Patent No.: US 10,660,887 B2 Javitt (45 ) Date of Patent: *May 26 , 2020
US010660887B2 United States Patent (10 ) Patent No.: US 10,660,887 B2 Javitt (45 ) Date of Patent : *May 26 , 2020 (54 ) COMPOSITION AND METHOD FOR (56 ) References Cited TREATMENT OF DEPRESSION AND PSYCHOSIS IN HUMANS U.S. PATENT DOCUMENTS 6,228,875 B1 5/2001 Tsai et al. ( 71 ) Applicant : Glytech , LLC , Ft. Lee , NJ (US ) 2004/0157926 A1 * 8/2004 Heresco - Levy A61K 31/198 514/561 (72 ) Inventor: Daniel C. Javitt , Ft. Lee , NJ (US ) 2005/0261340 Al 11/2005 Weiner 2006/0204486 Al 9/2006 Pyke et al . 2008/0194631 Al 8/2008 Trovero et al. ( 73 ) Assignee : GLYTECH , LLC , Ft. Lee , NJ (US ) 2008/0194698 A1 8/2008 Hermanussen et al . 2010/0069399 A1 * 3/2010 Gant CO7D 401/12 ( * ) Notice : Subject to any disclaimer, the term of this 514 / 253.07 patent is extended or adjusted under 35 2010/0216805 Al 8/2010 Barlow 2011/0207776 Al 8/2011 Buntinx U.S.C. 154 ( b ) by 95 days . 2011/0237602 A1 9/2011 Meltzer This patent is subject to a terminal dis 2011/0306586 Al 12/2011 Khan claimer . 2012/0041026 A1 2/2012 Waizumi ( 21 ) Appl. No.: 15 /650,912 FOREIGN PATENT DOCUMENTS CN 101090721 12/2007 ( 22 ) Filed : Jul. 16 , 17 KR 2007 0017136 2/2007 WO 2005/065308 7/2005 (65 ) Prior Publication Data WO 2005/079756 9/2005 WO 2011044089 4/2011 US 2017/0312275 A1 Nov. 2 , 2017 WO 2012/104852 8/2012 WO 2005/000216 9/2013 WO 2013138322 9/2013 Related U.S. Application Data (63 ) Continuation of application No.