5-HT Receptor Serotonin Receptor;5-Hydroxytryptamine Receptor
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Corporate Release No 485 12 December 2012 FDA Accepts
H. Lundbeck A/S Ottiliavej 9 Tel +45 36 30 13 11 E-mail [email protected] DK-2500 Valby, Copenhagen Fax +45 36 43 82 62 www.lundbeck.com CVR number: 56759913 Corporate Release No 485 12 December 2012 FDA accepts Takeda and Lundbeck’s filing for review of Brintellix (vortioxetine) for the treatment of major depression FDA has determined that the New Drug Application filed in October 2012 is sufficiently complete to permit a substantive review Upon the acceptance of the filing by the FDA, Lundbeck is to receive a milestone of USD 50 million (approximately DKK 285 million) from Takeda H. Lundbeck A/S (Lundbeck) announced today that the U.S. Food and Drug Administration (FDA) has accepted the submission of a New Drug Application (NDA) for BrintellixTM (vortioxetine) for the treatment of major depressive disorder (MDD) in adult patients. Brintellix (pronounced “brin′-tel-ix”) is the proposed global trade name for vortioxetine. According to the timelines established by the Prescription Drug User Fee Act (PDUFA), the review of the NDA is targeted for completion by 2 October, 2013. The NDA includes positive data from six short-term studies and one long-term maintenance study. The vortioxetine global clinical development program included more than 7,500 individuals aged 18 to 88 years old exposed to the drug. Major depression, often referred to as depression, is a common, debilitating illness affecting around 15 million Americans and 121 million people worldwide. Depression was the third leading contributor to the global burden of disease in 2004 and is projected to be the leading contributor to the worldwide burden of disease by 2030. -
Pindolol of the Activation of Postsynaptic 5-HT1A Receptors
Potentiation by (-)Pindolol of the Activation of Postsynaptic 5-HT1A Receptors Induced by Venlafaxine Jean-Claude Béïque, Ph.D., Pierre Blier, M.D., Ph.D., Claude de Montigny, M.D., Ph.D., and Guy Debonnel, M.D. The increase of extracellular 5-HT in brain terminal regions antagonist WAY 100635 (100 g/kg, i.v.). A short-term produced by the acute administration of 5-HT reuptake treatment with VLX (20 mg/kg/day ϫ 2 days) resulted in a inhibitors (SSRI’s) is hampered by the activation of ca. 90% suppression of the firing activity of 5-HT neurons somatodendritic 5-HT1A autoreceptors in the raphe nuclei. in the dorsal raphe nucleus. This was prevented by the The present in vivo electrophysiological studies were coadministration of (-)pindolol (15 mg/kg/day ϫ 2 days). undertaken, in the rat, to assess the effects of the Taken together, these results indicate that (-)pindolol coadministration of venlafaxine, a dual 5-HT/NE reuptake potentiated the activation of postsynaptic 5-HT1A receptors inhibitor, and (-)pindolol on pre- and postsynaptic 5-HT1A resulting from 5-HT reuptake inhibition probably by receptor function. The acute administration of venlafaxine blocking the somatodendritic 5-HT1A autoreceptor, but not and of the SSRI paroxetine (5 mg/kg, i.v.) induced a its postsynaptic congener. These results support and extend suppression of the firing activity of dorsal hippocampus CA3 previous findings providing a biological substratum for the pyramidal neurons. This effect of venlafaxine was markedly efficacy of pindolol as an accelerating strategy in major potentiated by a pretreatment with (-)pindolol (15 mg/kg, depression. -
ZHONG-THESIS-2016.Pdf
ANTIDEPRESSANTMINING AZ AMAZ DESIGNING A WEBBASED ALGORITHM AND VISUAL LANGUAGE FOR ANTIDEPRESSANT DRUG SELECTION TO EDUCATE PRIMARY CARE PRACTITIONERS By Amy Zhong A thesis submitted to Johns Hopkins University in conformity with the requirements for the degree of Master of Arts Baltimore, Maryland March, 2016 © 2016 Amy Zhong All Rights Reserved ABSTRACT Depression is a common mental disorder that affects approximately 14.8 million American adults each year. In addition to being a debilitating condition, depression often occurs in tandem with other medical conditions such as diabetes, heart disease, and cancer. While psychiatric professionals are essential for the management of mental health, majority of patients seek care from their primary care practitioners. This phenomenon is of great concern because diagnosis of depression within primary care settings has only been accurate 25-50% of the time. The antidepressant drug selection algorithm utilizes a unique formula to integrate patient and family medical histories, patient symptoms, and patient preferences to make optimal treatment selections. The development of a visual language explores the use of graphic elements to improve understanding of major pharmacological mechanisms, knowledge essential to making rational DQWLGHSUHVVDQWGUXJVHOHFWLRQV,QFUHDWLQJWKLVPRELOHZHEEDVHGDSSOLFDWLRQZHKRSHWR¿OOD void in resources available to primary care practitioners, and improve management of mental health within the primary care setting. By Amy Zhong Chairpersons of the Supervisory Committee Adam I. Kaplin, M.D., Ph.D., esis Preceptor Assistant Professor, Departments of Psychiatry and Neurology e Johns Hopkins University School of Medicine Kristen Rahn Hollinger, Ph.D., esis Preceptor Instructor, Departments of Psychiatry and Neurology e Johns Hopkins University School of Medicine Jennifer E. -
(12) United States Patent (10) Patent No.: US 9,381,189 B2 Green Et Al
US009381189B2 (12) United States Patent (10) Patent No.: US 9,381,189 B2 Green et al. (45) Date of Patent: Jul. 5, 2016 (54) INGREDIENTS FOR INHALATION AND (56) References Cited METHODS FOR MAKING THE SAME U.S. PATENT DOCUMENTS (75) Inventors: Matthew Michael James Green, 4,582,265 A * 4/1986 Petronelli ....................... 241.95 Wiltshire (GB); Richard Michael Poole, 6,257,233 B1 7/2001 Burr et al. 2004/01 18007 A1* 6/2004 Chickering et al. ............ 34/360 Wiltshire (GB) 2006, O257491 A1* 11, 2006 Morton et al. ... 424/489 (73) Assignee: VECTURA LIMITED, Wiltshire (GB) 2008/0063719 A1 3/2008 Morton et al. ................ 424/489 (*) Notice: Subject to any disclaimer, the term of this FOREIGN PATENT DOCUMENTS patent is extended or adjusted under 35 EP O709086 A2 5, 1996 U.S.C. 154(b) by 641 days. EP 14981 16 A1 1, 2005 GB 2387781 A 10, 2003 JP 2005298.347 10/2005 (21) Appl. No.: 13/514,672 JP 200954.1393 11, 2009 JP 2012,542618 6, 2012 (22) PCT Fled: Dec. 8, 2010 WO 96.23485 A1 8, 1996 WO 9703649 A1 2, 1997 (86) PCT NO.: PCT/GB2O10/052053 WO O2OO197 A1 1, 2002 WO O243701 A2 6, 2002 S371 (c)(1), WO 2005105043 A2 11/2005 Aug. 20, 2012 WO 2007053904 A1 5/2007 (2), (4) Date: WO 2008.000482 1, 2008 (87) PCT Pub. No.: WO2O11AO70361 WO 2009095684 A1 8, 2009 OTHER PUBLICATIONS PCT Pub. Date: Jun. 16, 2011 Brunauer et al. "Adsorption of Gases in Multimolecular Layers'. J. (65) Prior Publication Data Am. -
Strategies for Managing Sexual Dysfunction Induced by Antidepressant Medication
King’s Research Portal DOI: 10.1002/14651858.CD003382.pub3 Document Version Publisher's PDF, also known as Version of record Link to publication record in King's Research Portal Citation for published version (APA): Taylor, M. J., Rudkin, L., Bullemor-Day, P., Lubin, J., Chukwujekwu, C., & Hawton, K. (2013). Strategies for managing sexual dysfunction induced by antidepressant medication. Cochrane Database of Systematic Reviews, (5). https://doi.org/10.1002/14651858.CD003382.pub3 Citing this paper Please note that where the full-text provided on King's Research Portal is the Author Accepted Manuscript or Post-Print version this may differ from the final Published version. If citing, it is advised that you check and use the publisher's definitive version for pagination, volume/issue, and date of publication details. And where the final published version is provided on the Research Portal, if citing you are again advised to check the publisher's website for any subsequent corrections. General rights Copyright and moral rights for the publications made accessible in the Research Portal are retained by the authors and/or other copyright owners and it is a condition of accessing publications that users recognize and abide by the legal requirements associated with these rights. •Users may download and print one copy of any publication from the Research Portal for the purpose of private study or research. •You may not further distribute the material or use it for any profit-making activity or commercial gain •You may freely distribute the URL identifying the publication in the Research Portal Take down policy If you believe that this document breaches copyright please contact [email protected] providing details, and we will remove access to the work immediately and investigate your claim. -
Centre for Reviews and Dissemination
Second-generation versus first-generation antipsychotic drugs for schizophrenia: a meta- analysis Leucht S, Corves C, D Arbter, Engel R R, Li C, Davis J M CRD summary The authors concluded that amisulpride, clozapine, olanzapine and risperidone can be effective in treating schizophrenia patients. Second-generation antipsychotic drugs can also result in fewer extrapyramidal side effects, but can induce weight gain. The authors' conclusions reflected the evidence presented, but some potential methodological flaws in the review process meant that the extent to which those conclusions were reliable was unclear. Authors' objectives To compare the effects of first and second-generation antipsychotic drugs in schizophrenia patients. Searching The search for eligible studies was started in 2005, including MEDLINE to October 2006, Cochrane Schizophrenia Group's Specialised Register and the US Food and Drugs Administration website. Search terms were reported and there were no language restrictions. Previous reviews were searched for additional relevant studies. Study selection Randomised controlled trials (RCTs) of oral second-generation antipsychotic drugs (amisulpride, aripiprazole, clozapine, olanzapine, quetiapine, risperidone, sertindole, ziprasidone and zotepine) compared with first-generation drugs in patients with schizophrenia or related disorders (schizoaffective, schizophreniform or delusional disorders) irrespective of diagnostic criteria were eligible for inclusion in the review. The optimum doses of second-generation drugs were selected -
Serotonin Receptors and Their Role in the Pathophysiology and Therapy of Irritable Bowel Syndrome
Tech Coloproctol DOI 10.1007/s10151-013-1106-8 REVIEW Serotonin receptors and their role in the pathophysiology and therapy of irritable bowel syndrome C. Stasi • M. Bellini • G. Bassotti • C. Blandizzi • S. Milani Received: 19 July 2013 / Accepted: 2 December 2013 Ó Springer-Verlag Italia 2013 Abstract Results Several lines of evidence indicate that 5-HT and Background Irritable bowel syndrome (IBS) is a functional its receptor subtypes are likely to have a central role in the disorder of the gastrointestinal tract characterized by pathophysiology of IBS. 5-HT released from enterochro- abdominal discomfort, pain and changes in bowel habits, maffin cells regulates sensory, motor and secretory func- often associated with psychological/psychiatric disorders. It tions of the digestive system through the interaction with has been suggested that the development of IBS may be different receptor subtypes. It has been suggested that pain related to the body’s response to stress, which is one of the signals originate in intrinsic primary afferent neurons and main factors that can modulate motility and visceral per- are transmitted by extrinsic primary afferent neurons. ception through the interaction between brain and gut (brain– Moreover, IBS is associated with abnormal activation of gut axis). The present review will examine and discuss the central stress circuits, which results in altered perception role of serotonin (5-hydroxytryptamine, 5-HT) receptor during visceral stimulation. subtypes in the pathophysiology and therapy of IBS. Conclusions Altered 5-HT signaling in the central ner- Methods Search of the literature published in English vous system and in the gut contributes to hypersensitivity using the PubMed database. -
The Effects of Antipsychotic Treatment on Metabolic Function: a Systematic Review and Network Meta-Analysis
The effects of antipsychotic treatment on metabolic function: a systematic review and network meta-analysis Toby Pillinger, Robert McCutcheon, Luke Vano, Katherine Beck, Guy Hindley, Atheeshaan Arumuham, Yuya Mizuno, Sridhar Natesan, Orestis Efthimiou, Andrea Cipriani, Oliver Howes ****PROTOCOL**** Review questions 1. What is the magnitude of metabolic dysregulation (defined as alterations in fasting glucose, total cholesterol, low density lipoprotein (LDL) cholesterol, high density lipoprotein (HDL) cholesterol, and triglyceride levels) and alterations in body weight and body mass index associated with short-term (‘acute’) antipsychotic treatment in individuals with schizophrenia? 2. Does baseline physiology (e.g. body weight) and demographics (e.g. age) of patients predict magnitude of antipsychotic-associated metabolic dysregulation? 3. Are alterations in metabolic parameters over time associated with alterations in degree of psychopathology? 1 Searches We plan to search EMBASE, PsycINFO, and MEDLINE from inception using the following terms: 1 (Acepromazine or Acetophenazine or Amisulpride or Aripiprazole or Asenapine or Benperidol or Blonanserin or Bromperidol or Butaperazine or Carpipramine or Chlorproethazine or Chlorpromazine or Chlorprothixene or Clocapramine or Clopenthixol or Clopentixol or Clothiapine or Clotiapine or Clozapine or Cyamemazine or Cyamepromazine or Dixyrazine or Droperidol or Fluanisone or Flupehenazine or Flupenthixol or Flupentixol or Fluphenazine or Fluspirilen or Fluspirilene or Haloperidol or Iloperidone -
PHARMACEUTICAL APPENDIX to the TARIFF SCHEDULE 2 Table 1
Harmonized Tariff Schedule of the United States (2020) Revision 19 Annotated for Statistical Reporting Purposes PHARMACEUTICAL APPENDIX TO THE HARMONIZED TARIFF SCHEDULE Harmonized Tariff Schedule of the United States (2020) Revision 19 Annotated for Statistical Reporting Purposes PHARMACEUTICAL APPENDIX TO THE TARIFF SCHEDULE 2 Table 1. This table enumerates products described by International Non-proprietary Names INN which shall be entered free of duty under general note 13 to the tariff schedule. The Chemical Abstracts Service CAS registry numbers also set forth in this table are included to assist in the identification of the products concerned. For purposes of the tariff schedule, any references to a product enumerated in this table includes such product by whatever name known. -
Clinical Expertise and Patient Focus November, 2019
Clinical Expertise and Patient Focus November, 2019 1 Forward-Looking Statement Safe-Harbor This presentation contains forward-looking statements about Minerva whether any of our therapeutic products will advance further in the Neurosciences which are subject to the safe harbor provisions of the clinical trials process and whether and when, if at all, they will receive Private Securities Litigation Reform Act of 1995, as amended. Forward- final approval from the U.S. Food and Drug Administration or looking statements are statements that are not historical facts, reflect equivalent foreign regulatory agencies and for which indications; management’s expectations as of the date of this presentation, and whether the results of future clinical trials of roluperidone, seltorexant, involve certain risks and uncertainties. Forward-looking statements MIN-117 and MIN-301, if any, will be consistent with the results of past include, but are not limited to: the benefits, efficacy and safety of our clinical trials; whether roluperidone, seltorexant, MIN-117 and MIN-301 new formulations; the potential of the diagnosis and treatment of will be successfully marketed if approved; whether our therapeutic negative symptoms of schizophrenia and other diseases; whether product discovery and development efforts will be successful; our studies performed on analogs or backups of our compounds are a good ability to achieve the results contemplated by our co-development predictor of the clinical efficacy of our compounds; statements with agreements; the strength -
Poster Session III, December 6, 2017
Neuropsychopharmacology (2017) 42, S476–S652 © 2017 American College of Neuropsychopharmacology. All rights reserved 0893-133X/17 www.neuropsychopharmacology.org Poster Session III a high-resolution research tomograph (HRRT), and struc- Palm Springs, California, December 3–7, 2017 tural (T1) MRI using a 3-Tesla scanner. PET data analyses were carried out using the validated 2-tissue compartment Sponsorship Statement: Publication of this supplement is model to determine the total volume of distribution (VT) of sponsored by the ACNP. [18F]FEPPA. Individual contributor disclosures may be found within the Results: Results show significant inverse associations (con- abstracts. Part 1: All Financial Involvement with a pharma- trolling for rs6971 genotype) between neuroinflammation ceutical or biotechnology company, a company providing (VTs) and cortical thickness in the right medial prefrontal clinical assessment, scientific, or medical products or compa- cortex [r = -.562, p = .029] and the left dorsolateral nies doing business with or proposing to do business with prefrontal cortex [r = -.629, p = .012](p values are not ACNP over past 2 years (Calendar Years 2014–Present); Part 2: corrected for multiple comparisons). No significant associa- Income Sources & Equity of $10,000 per year or greater tions were found with surface area. (Calendar Years 2014 - Present): List those financial relation- Conclusions: These results, while preliminary, suggest links ships which are listed in part one and have a value greater than between the microglial activation/neuroinflammation and $10,000 per year, OR financial holdings that are listed in part cortical thickness in the dorsolateral prefrontal cortex and one and have a value of $10,000 or greater as of the date of medial prefrontal cortex in AD patients. -
Stems for Nonproprietary Drug Names
USAN STEM LIST STEM DEFINITION EXAMPLES -abine (see -arabine, -citabine) -ac anti-inflammatory agents (acetic acid derivatives) bromfenac dexpemedolac -acetam (see -racetam) -adol or analgesics (mixed opiate receptor agonists/ tazadolene -adol- antagonists) spiradolene levonantradol -adox antibacterials (quinoline dioxide derivatives) carbadox -afenone antiarrhythmics (propafenone derivatives) alprafenone diprafenonex -afil PDE5 inhibitors tadalafil -aj- antiarrhythmics (ajmaline derivatives) lorajmine -aldrate antacid aluminum salts magaldrate -algron alpha1 - and alpha2 - adrenoreceptor agonists dabuzalgron -alol combined alpha and beta blockers labetalol medroxalol -amidis antimyloidotics tafamidis -amivir (see -vir) -ampa ionotropic non-NMDA glutamate receptors (AMPA and/or KA receptors) subgroup: -ampanel antagonists becampanel -ampator modulators forampator -anib angiogenesis inhibitors pegaptanib cediranib 1 subgroup: -siranib siRNA bevasiranib -andr- androgens nandrolone -anserin serotonin 5-HT2 receptor antagonists altanserin tropanserin adatanserin -antel anthelmintics (undefined group) carbantel subgroup: -quantel 2-deoxoparaherquamide A derivatives derquantel -antrone antineoplastics; anthraquinone derivatives pixantrone -apsel P-selectin antagonists torapsel -arabine antineoplastics (arabinofuranosyl derivatives) fazarabine fludarabine aril-, -aril, -aril- antiviral (arildone derivatives) pleconaril arildone fosarilate -arit antirheumatics (lobenzarit type) lobenzarit clobuzarit -arol anticoagulants (dicumarol type) dicumarol