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Автор: Grafiati

Опубліковано: 14 березня 2023

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1

Johnsa, Jessica D., and Michael W. Neville. "Tasimelteon." Annals of Pharmacotherapy 48, no. 12 (September 9, 2014): 1636–41. http://dx.doi.org/10.1177/1060028014550476.

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2

Bonacci, Janene M., Jineane V. Venci, and Mona A. Gandhi. "Tasimelteon (Hetlioz™)." Journal of Pharmacy Practice 28, no. 5 (August 3, 2014): 473–78. http://dx.doi.org/10.1177/0897190014544792.

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In January 2014, the US Food and Drug Administration approved tasimelteon (Hetlioz™), a melatonin-receptor agonist for the treatment of non-24-hour sleep–wake disorder. This article provides an overview of the mechanism of action, pharmacokinetic properties, as well as the clinical efficacy, safety, and tolerability of tasimelteon. Relevant information was identified through a comprehensive literature search of several databases using the key words tasimelteon, Non-24-hour Sleep–Wake disorder, Non-24, and melatonin. Further information was obtained from the tasimelteon package insert, fda.gov , clinicaltrials.gov , briefing materials provided by Vanda Pharmaceuticals, and posters from scientific meetings.

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3

Brooks, J., M. Gibson, K. Kite, E. Czeisler, M. Fisher, C. Xiao, C. Polymeropoulos, and M. Polymeropoulos. "1161 Tasimelteon Shows Persistence Of Efficacy In Improving Sleep Disturbances In Patients With Smith-Magenis Syndrome (SMS) In Open-Label Extension Study." Sleep 43, Supplement_1 (April 2020): A442—A444. http://dx.doi.org/10.1093/sleep/zsaa056.1155.

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Abstract Introduction Smith-Magenis Syndrome (SMS) is a rare (1/15,000 - 25,000 births) neurodevelopmental disorder resulting from an interstitial deletion of chromosome 17p11.2, or from a point mutation in the RAI1 gene. Severe sleep disorder is almost universal in patients with SMS and poses a significant challenge to patients and their families. Tasimelteon improved sleep symptoms in a randomized, double-blind, two-period, crossover study; and here we show that this effect persists for up to four years in an open-label extension. To our knowledge, this is the largest interventional study of SMS patients to date. Methods Following the 4-week crossover study, all eligible participants had the option to enroll in an open-label extension. 31/39 (79.4%) of all individuals who participated in the efficacy study have continued on tasimelteon treatment. Participants in the open-label extension provided daily diary sleep quality (DDSQ), and daily diary total sleep time (DDTST) measures via parental post sleep questionnaire and characterized behavior using the Aberrant Behavior Checklist (ABC). Results In the open-label extension, tasimelteon continued to show improvement in the primary endpoints of 50% worst sleep quality (mean = 0.7, SD = 0.94) and 50% worst total nighttime sleep duration (mean = 53.3, SD = 59.01) when compared to baseline. Tasimelteon also improved overall sleep quality (mean=0.7, SD=0.83) and overall total nighttime sleep duration (mean = 51.9, SD=53.03). ABC scores also improved with tasimelteon (mean= -16.3, SD = 15.82). Conclusion Tasimelteon continues to demonstrate persistence in efficacy (longest approximately 4 years) with similar magnitudes observed in the 4-week crossover study for sleep quality and total sleep time. Interestingly, daytime behavior also demonstrates long-term improvement in patients with SMS treated with tasimelteon. These results further confirm tasimelteon as a novel therapy for the treatment of sleep disorders in patients with SMS and may provide benefit for behavioral symptoms. Support This work was supported by Vanda Pharmaceuticals Inc.

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4

Lankford, D. Alan. "Tasimelteon for insomnia." Expert Opinion on Investigational Drugs 20, no. 7 (May 9, 2011): 987–93. http://dx.doi.org/10.1517/13543784.2011.583235.

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5

&NA;. "Tasimelteon tackles chronic insomnia." Inpharma Weekly &NA;, no. 1645 (July 2008): 5. http://dx.doi.org/10.2165/00128413-200816450-00013.

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6

Torres, Rosarelis, Marlene A. Dressman, William G. Kramer, and Paolo Baroldi. "Absolute Bioavailability of Tasimelteon." American Journal of Therapeutics 22, no. 5 (2015): 355–60. http://dx.doi.org/10.1097/mjt.0000000000000195.

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7

Li, Xi-An, Lirong Yue, Jianrong Zhu, Huazhong Ren, Hong Zhang, Dong-yan Hu, Guangtian Han, Jiafu Feng, and Ze-dong Nan. "Total synthesis of Tasimelteon." Tetrahedron Letters 60, no. 30 (July 2019): 1986–88. http://dx.doi.org/10.1016/j.tetlet.2019.06.048.

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8

Dhillon, Sohita, and Madeleine Clarke. "Tasimelteon: First Global Approval." Drugs 74, no. 4 (March 2014): 505–11. http://dx.doi.org/10.1007/s40265-014-0200-1.

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9

&NA;. "Tasimelteon helps transient insomniacs nod off." Inpharma Weekly &NA;, no. 1667 (December 2008): 11. http://dx.doi.org/10.2165/00128413-200816670-00033.

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10

Adams, Katie S., and Ericka L. Breden Crouse. "Melatonin agonists in the management of sleep disorders: A focus on ramelteon and tasimelteon." Mental Health Clinician 4, no. 2 (March 1, 2014): 59–64. http://dx.doi.org/10.9740/mhc.n190087.

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Анотація:

Melatonin agonists have become an area of interest in the treatment of sleep disorders. This article reviews the available data on this class of medications, with a focus on ramelteon and tasimelteon.

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11

Mi, Senyang, Xinzhe Sun, Chaogang Wu, and Xingxian Zhang. "A Facile and Practical Synthesis of (-)-tasimelteon." Journal of Chemical Research 40, no. 11 (November 2016): 667–69. http://dx.doi.org/10.3184/174751916x14758368248634.

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12

Stahl, Stephen M. "Mechanism of action of tasimelteon in non-24 sleep-wake syndrome: treatment for a circadian rhythm disorder in blind patients." CNS Spectrums 19, no. 6 (November 25, 2014): 475–78. http://dx.doi.org/10.1017/s1092852914000637.

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ISSUE:Many individuals with total blindness can develop a circadian rhythm disorder—called non-24 sleep wake syndrome—because they cannot detect light to resynchronize their sleep–wake cycles. A new melatonin 1 and melatonin 2 agonist tasimelteon improves sleep in these patients, resetting their circadian sleep–wake clocks.

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13

Traynor, Kate. "Tasimelteon approved for circadian disorder in blind adults." American Journal of Health-System Pharmacy 71, no. 5 (March 1, 2014): 350. http://dx.doi.org/10.2146/news140017.

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14

Lavedan, Christian, Mark Forsberg, and Anthony J. Gentile. "Tasimelteon: A selective and unique receptor binding profile." Neuropharmacology 91 (April 2015): 142–47. http://dx.doi.org/10.1016/j.neuropharm.2014.12.004.

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15

Wang, Wenbing, Xiangwei Meng, Jianrong Zhu, and Xingxian Zhang. "An efficient and practical asymmetric synthesis of (−)-tasimelteon." Synthetic Communications 49, no. 1 (January 2, 2019): 129–35. http://dx.doi.org/10.1080/00397911.2018.1545031.

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16

Yuhas, Phillip T. "Non-24-Hour Sleep–Wake Disorder and Tasimelteon: A Review for Practitioners Who Work With Blind People." Journal of Visual Impairment & Blindness 116, no. 1 (January 2022): 70–84. http://dx.doi.org/10.1177/0145482x211072521.

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Анотація:

Introduction This narrative review summarizes the biology of human circadian rhythms; details the epidemiology, clinical manifestation, and diagnosis of non-24-hour sleep–wake disorder (N24SWD); and reviews the efficacy of possible treatments. Methods Searches of targeted phrases, such as “non-24-hour sleep–wake disorder” and “tasimelteon,” were conducted on PubMed between December 2016 and March 2020. Results As the world’s population ages, health practitioners frequently work with people who are blind. Damage to the retinal ganglion cells that signal environmental irradiance levels to the suprachiasmatic nucleus prevents many of these individuals from synchronizing their internal clocks to the 24-hour day. As a result, they experience a condition called N24SWD, where the body’s circadian rhythms fall in and out of phase with the solar cycle. The ability to fall asleep and remain asleep is a complex process that depends on many variables, including the release of the neurohormone melatonin. Melatonin is produced at night and is a key regulator of regular sleep cycles. Periods of interrupted sleep, increased sleep latency, and reduced total sleep time occur when melatonin production peaks during daytime. Thus, many persons with N24SWD have difficulty maintaining normal schedules due in part to the mistimed release of melatonin. Randomized clinical trials have shown that melatonin receptor agonist tasimelteon is an effective therapy for individuals with N24SWD. Other treatments have varying efficacy profiles. Conclusions Although rare, N24SWD is a serious condition that can impair quality of life for blind persons. Tasimelteon appears to be a safe and efficacious treatment option. Implications for Practitioners Practitioners can use this information to better understand why blind persons often report difficulties sleeping and to realize that therapeutic options are available to these individuals.

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17

Polymeropoulos, C., E. Czeisler, M. Fisher, G. Birznieks, C. Xiao, V. Polymeropoulos, and M. Polymeropoulos. "Tasimelteon effective in treating JET lag during transatlantic travel." Sleep Medicine 64 (December 2019): S305. http://dx.doi.org/10.1016/j.sleep.2019.11.854.

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18

Liu, Kaihang, Xinbo Zhou, Zhejing Xu, Hongzhen Bai, Jianrong Zhu, Jianming Gu, Guping Tang, Xingang Liu, and Xiurong Hu. "Anhydrates and hemihydrate of tasimelteon: Synthesis, structure, and pharmacokinetic study." Journal of Pharmaceutical and Biomedical Analysis 151 (March 2018): 235–43. http://dx.doi.org/10.1016/j.jpba.2017.12.035.

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19

Polymeropoulos, Christos, Emily Czeisler, Michaela Fisher, Gunther Birznieks, Vasilios Polymeropoulos, Changfu Xiao, and Mihael Polymeropoulos. "0639 Tasimelteon Effective in Treating Jet Lag during Transatlantic Travel." Sleep 42, Supplement_1 (April 2019): A254—A255. http://dx.doi.org/10.1093/sleep/zsz067.637.

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20

Nishimon, Shohei, Mari Nishimon, and Seiji Nishino. "Tasimelteon for treating non-24-h sleep-wake rhythm disorder." Expert Opinion on Pharmacotherapy 20, no. 9 (April 16, 2019): 1065–73. http://dx.doi.org/10.1080/14656566.2019.1603293.

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21

Neubauer, D. N. "Tasimelteon for the treatment of non-24-hour sleep-wake disorder." Drugs of Today 51, no. 1 (2015): 29. http://dx.doi.org/10.1358/dot.2015.51.1.2258364.

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22

Polymeropoulos, M. H., C. Xiao, and C. Polymeropoulos. "Tasimelteon improves symptoms of major depression in an African American population." Sleep Medicine 40 (December 2017): e266. http://dx.doi.org/10.1016/j.sleep.2017.11.779.

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23

Petrini, Agnese, Giovanni Ievoli, Francesca Migliorini, Maurizio Taddei, and Sofia Siciliano. "A Self-Immolative Linker for the pH-Responsive Release of Amides." Molecules 28, no. 6 (March 7, 2023): 2445. http://dx.doi.org/10.3390/molecules28062445.

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The administration of therapeutics using bioconjugation has been mainly limited to drugs containing amine, alcohol, or thiol functional groups. Here, we report a general procedure for the preparation of benzylic N-acyl carbamates suitable for masking the amide group in important drugs such as Linezolid, Enzalutamide, or Tasimelteon in good to acceptable yields. These N-acyl carbamates appear to be stable in plasma, while a qualitative analysis of further drug uncage demonstrates that, at pH values of 5.5, a classical 1,6-benzyl elimination mechanism takes place, releasing more than 80% of the drug in 24 h.

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24

Polymeropoulos, M., C. Xiao, and C. Polymeropoulos. "0986 Tasimelteon Improves Symptoms of Major Depression in an African American Population." Sleep 41, suppl_1 (April 2018): A365—A366. http://dx.doi.org/10.1093/sleep/zsy061.985.

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25

de Klaver, P. A. G. "Melatonine agonist tasimelteon (VEC-162) bij voorbijgaande insomnia na nachtdienst: 2 gerandomiseerde onderzoeken." Medisch-Farmaceutische Mededelingen 47, no. 6 (June 2009): 93–94. http://dx.doi.org/10.1007/bf03079969.

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26

Polymeropoulos, C., E. Czeisler, M. Fisher, G. Birznieks, V. Polymeropoulos, C. Xiao, and M. Polymeropoulos. "Tasimelteon demonstrates efficacy in improving sleep disturbances of individuals with smith-magenis syndrome (SMS)." Sleep Medicine 64 (December 2019): S423. http://dx.doi.org/10.1016/j.sleep.2019.11.1176.

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27

Ogilvie, Brian W., Rosarelis Torres, Marlene A. Dressman, William G. Kramer, and Paolo Baroldi. "Clinical assessment of drug–drug interactions of tasimelteon, a novel dual melatonin receptor agonist." Journal of Clinical Pharmacology 55, no. 9 (May 7, 2015): 1004–11. http://dx.doi.org/10.1002/jcph.507.

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28

Keating, Gillian M. "Tasimelteon: A Review in Non-24-Hour Sleep-Wake Disorder in Totally Blind Individuals." CNS Drugs 30, no. 5 (March 22, 2016): 461–68. http://dx.doi.org/10.1007/s40263-016-0330-y.

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29

Polymeropoulos, Christos, Emily Czeisler, Michaela Fisher, Gunther Birznieks, Vasilios Polymeropoulos, Changfu Xiao, and Mihael Polymeropoulos. "0641 Tasimelteon Demonstrates Efficacy in Improving Sleep Disturbances of Individuals with Smith-Magenis Syndrome (SMS)." Sleep 42, Supplement_1 (April 2019): A255. http://dx.doi.org/10.1093/sleep/zsz067.639.

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30

Torres, Rosarelis, William G. Kramer, and Paolo Baroldi. "Pharmacokinetics of the dual melatonin receptor agonist tasimelteon in subjects with hepatic or renal impairment." Journal of Clinical Pharmacology 55, no. 5 (February 4, 2015): 525–33. http://dx.doi.org/10.1002/jcph.440.

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31

Satyanarayanan, Senthil Kumaran, Huanxing Su, Yi-Wen Lin, and Kuan-Pin Su. "Circadian Rhythm and Melatonin in the Treatment of Depression." Current Pharmaceutical Design 24, no. 22 (October 19, 2018): 2549–55. http://dx.doi.org/10.2174/1381612824666180803112304.

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Анотація:

Background: Circadian rhythm disruption underlies the pathophysiology of psychiatric disorders, especially depression. Both pharmacological and non-pharmacological strategies affecting endogenous circadian rhythms have been developed with specificity to alter the circadian dysfunction. The current management strategy with antidepressants is far from being satisfactory in addressing this issue. In recent years, attempts at discovering new antidepressants focused on a melatonergic system which is known to be altered in depression have led to a potential option for treatment of depression. Methods: We reviewed all recently published relevant articles on melatonin and its analogues to look for their implication in the treatment of circadian rhythm disruption and depression. Results: Melatonin, a pleiotropic regulator molecule and its analogues (ramelteon, agomelatine, TIK-301, Neu- P11 and tasimelteon) have been observed to resynchronize the circadian rhythm and some were said to alleviate depressive symptoms in depressed subjects. Conclusion: This review focuses on substantial advances in the melatonin-based chronobiologic intervention and its responses in the treatment of depression.

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32

Erland, Lauren A. E., Christopher R. Dumigan, Jillian A. Forsyth, Liubov Frolova, Adam B. Yasunaga, Winnie Pun, Isaac T. S. Li, Michael K. Deyholos, and Susan J. Murch. "Mammalian Melatonin Agonist Pharmaceuticals Stimulate Rhomboid Proteins in Plants." Biomolecules 12, no. 7 (June 24, 2022): 882. http://dx.doi.org/10.3390/biom12070882.

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Melatonin is a human neurotransmitter and plant signalling metabolite that perceives and directs plant metabolism. The mechanisms of melatonin action in plants remain undefined. We hypothesized that roots have a melatonin-specific receptor and/or transporter that can respond to melatonin-mediating pharmaceuticals. To test this hypothesis Arabidopsis seedlings were grown with melatonin pharmaceutical receptor agonists: ramelteon and tasimelteon, and/or antagonists: luzindole and 4-P-PDOT. Ramelteon was found both to mimic and competitively inhibit melatonin metabolism in plants. Due to the higher selectivity of ramelteon for the MT1 receptor type in humans, a sequence homology search for MT1 in Arabidopsis identified the rhomboid-like protein 7 (RBL7). In physiological studies, Arabidopsis rbl7 mutants were less responsive to ramelteon and melatonin. Quantum dot visualizations of the effects of ramelteon on melatonin binding to root cell membranes revealed a potential mechanism. We propose that RBL7 is a melatonin-interacting protein that directs root architecture and growth in a mechanism that is responsive to environmental factors.

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33

Edmonds, Chelsey, and Michael Swanoski. "A Review of Suvorexant, Doxepin, Ramelteon, and Tasimelteon for the Treatment of Insomnia in Geriatric Patients." Consultant Pharmacist 32, no. 3 (March 1, 2017): 156–60. http://dx.doi.org/10.4140/tcp.n.2017.156.

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34

Ventimiglia, Giampiero, Sonja Bellomi, Giuseppe Barreca, Lorella Giovannelli, and Norberto Masciocchi. "Synthesis, Characterization, and Crystal Chemistry of Tasimelteon, a Melatonin Agonist, in Its Anhydrous and Hemihydrate Forms." Journal of Pharmaceutical Sciences 107, no. 2 (February 2018): 543–49. http://dx.doi.org/10.1016/j.xphs.2017.09.012.

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35

Xiao, C., C. Polymeropoulos, J. Brzezynski, L. Prokosch, M. Keefe, M. Mohrman, G. Birznieks, and M. Polymeropoulos. "Tasimelteon demonstrates efficacy to treat jet lag disorder in an 8 hour phase advance clinical study." Sleep Medicine 64 (December 2019): S423. http://dx.doi.org/10.1016/j.sleep.2019.11.1175.

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36

Leger, Damien, Maria-Antonia Quera-Salva, Marie-Françoise Vecchierini, Pascale Ogrizek, Christina A. Perry, and Marlene A. Dressman. "Safety profile of tasimelteon, a melatonin MT1and MT2receptor agonist: pooled safety analyses from six clinical studies." Expert Opinion on Drug Safety 14, no. 11 (September 22, 2015): 1673–85. http://dx.doi.org/10.1517/14740338.2015.1093112.

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37

Rajaratnam, Shantha MW, Mihael H. Polymeropoulos, Dennis M. Fisher, Thomas Roth, Christin Scott, Gunther Birznieks, and Elizabeth B. Klerman. "Melatonin agonist tasimelteon (VEC-162) for transient insomnia after sleep-time shift: two randomised controlled multicentre trials." Lancet 373, no. 9662 (February 2009): 482–91. http://dx.doi.org/10.1016/s0140-6736(08)61812-7.

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38

Polymeropoulos, Vasilios, Jim Wang, Christos Polymeropoulos, Changfu Xiao, and Mihael Polymeropoulos. "0640 Tasimelteon Significantly Improves REM Sleep Accumulation During an 8-hour Phase Advance in the JET8 Study." Sleep 42, Supplement_1 (April 2019): A255. http://dx.doi.org/10.1093/sleep/zsz067.638.

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39

Rajaratnam, Shantha M. W., Mihael H. Polymeropoulos, Dennis M. Fisher, Thomas Roth, Christin Scott, Gunther Birznieks, and Elizabeth B. Klerman. "Melatonin Agonist Tasimelteon (VEC-162) for Transient Insomnia After Sleep-Time Shift: Two Randomized Controlled Multicentre Trials." Obstetrical & Gynecological Survey 64, no. 9 (September 2009): 604–5. http://dx.doi.org/10.1097/01.ogx.0000358014.55641.1c.

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40

Moschona, Fotini, Ioanna Savvopoulou, Maria Tsitopoulou, Despoina Tataraki, and Gerasimos Rassias. "Epoxide Syntheses and Ring-Opening Reactions in Drug Development." Catalysts 10, no. 10 (September 27, 2020): 1117. http://dx.doi.org/10.3390/catal10101117.

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Анотація:

This review concentrates on success stories from the synthesis of approved medicines and drug candidates using epoxide chemistry in the development of robust and efficient syntheses at large scale. The focus is on those parts of each synthesis related to the substrate-controlled/diastereoselective and catalytic asymmetric synthesis of epoxide intermediates and their subsequent ring-opening reactions with various nucleophiles. These are described in the form of case studies of high profile pharmaceuticals spanning a diverse range of indications and molecular scaffolds such as heterocycles, terpenes, steroids, peptidomimetics, alkaloids and main stream small molecules. Representative examples include, but are not limited to the antihypertensive diltiazem, the antidepressant reboxetine, the HIV protease inhibitors atazanavir and indinavir, efinaconazole and related triazole antifungals, tasimelteon for sleep disorders, the anticancer agent carfilzomib, the anticoagulant rivaroxaban the antibiotic linezolid and the antiviral oseltamivir. Emphasis is given on aspects of catalytic asymmetric epoxidation employing metals with chiral ligands particularly with the Sharpless and Jacobsen–Katsuki methods as well as organocatalysts such as the chiral ketones of Shi and Yang, Pages’s chiral iminium salts and typical chiral phase transfer agents.

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41

Sukys-Claudino, Lucia, Walter André dos Santos Moraes, Sergio Tufik, and Dalva Poyares. "Novos sedativos hipnóticos." Revista Brasileira de Psiquiatria 32, no. 3 (September 2010): 288–93. http://dx.doi.org/10.1590/s1516-44462010000300014.

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Nas últimas décadas houve um esforço para o desenvolvimento de hipnóticos mais seguros e eficazes. Zolpidem, zaleplona, zopiclona, eszopiclona (drogas-z) e indiplona são moduladores do receptor GABA-A, os quais agem de forma seletiva na subunidade α1, exibindo, desta forma, mecanismos similares de ação, embora evidências recentes sugiram que a eszopiclona não seja tão seletiva para a subunidade α1 quanto o zolpidem. Ramelteon e tasimelteon são novos agentes crono-hipnóticos seletivos para os receptores de melatonina MT1 e MT2. Por outro lado, nos últimos anos, o consumo de drogas antidepressivas sedativas tem aumentado significativamente no tratamento da insônia. Como droga experimental, a eplivanserina tem sido testada como um potente agonista inverso do subtipo 5-HT2A da serotonina, com um uso potencial na dificuldade da manutenção do sono. Outro agente farmacológico para o tratamento da insônia é o almorexant, o qual apresenta um novo mecanismo de ação envolvendo antagonismo do sistema hipocretinérgico, desta forma levando à indução do sono. Finalmente, também discutiremos o potencial papel de outras drogas gabaérgicas no tratamento da insônia.

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Lockley, Steven, Marlene Dressman, Xiao Changfu, Dennis Fisher, Rosarelis Torres, Christian Lavedan, Louis Licamele, and Mihael Polymeropoulos. "Le tasimelteon entraîne l’horloge circadienne et procure une amélioration significative aux personnes totalement aveugles, souffrant du libre-cours." Médecine du Sommeil 12, no. 1 (January 2015): 55–56. http://dx.doi.org/10.1016/j.msom.2015.01.099.

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Hull, J. T., C. Polymeropoulos, Y. Cho, C. Xiao, and M. H. Polymeropoulos. "Tasimelteon improves sleep quality and behavior in individuals with Smith-Magenis syndrome (SMS) in an open-label study." Sleep Medicine 40 (December 2017): e139. http://dx.doi.org/10.1016/j.sleep.2017.11.406.

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Polymeropoulos, V., C. Polymeropoulos, G. Birznieks, C. Xiao, and M. Polymeropoulos. "Tasimelteon significantly improves time to 30 minutes of REM (REM30) as compared to placebo in the JET8 study." Sleep Medicine 64 (December 2019): S305. http://dx.doi.org/10.1016/j.sleep.2019.11.855.

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Van Draanen, L., C. Xiao, and M. H. Polymeropoulos. "0649 Tasimelteon Improves Number of Sleep Free Days in Blind Patients with Non-24-Hour Sleep-Wake Disorder." Sleep 41, suppl_1 (April 2018): A241. http://dx.doi.org/10.1093/sleep/zsy061.648.

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Hull, J. T., C. Polymeropoulos, C. Xiao, and M. H. Polymeropoulos. "0925 Tasimelteon Improves Sleep Quality and Behavior in Individuals with Smith-Magenis Syndrome (SMS) in an Open-Label Study." Sleep 41, suppl_1 (April 2018): A343. http://dx.doi.org/10.1093/sleep/zsy061.924.

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Quera-Salva, Maria-Antonia, Marlene Dressman, Christina Perry, Marie-Françoise Vecchierini, Pascale Ogrizek, Christian Lavedan, and Damien Leger. "Étude de sécurité, multicentrique, en ouvert, du tasimelteon pour le traitement du syndrome libre-cours chez les personnes totalement aveugles." Médecine du Sommeil 12, no. 1 (January 2015): 55. http://dx.doi.org/10.1016/j.msom.2015.01.098.

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Licamele, L., C. Xiao, ER Schreffler, A. Williams, and MH Polymeropoulos. "0709 TASIMELTEON TREATMENT ACHIEVED CLINICALLY IMPORTANT DIFFERENCE IN SLEEP QUALITY IN BLIND INDIVIDUALS WITH NON-24-HOUR SLEEP-WAKE DISORDER." Sleep 40, suppl_1 (April 28, 2017): A262—A263. http://dx.doi.org/10.1093/sleepj/zsx050.708.

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Dirks, Christina, Peter Young, and Anna Heidbreder. "Non-24h-Schlaf-Wach-Rhythmusstörung bei blinden Patienten." Nervenheilkunde 38, no. 03 (February 2019): 115–19. http://dx.doi.org/10.1055/a-0819-2962.

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Анотація:

ZusammenfassungSchlafstörungen sind bei blinden und sehbehinderten Patienten ein häufig unterschätztes Problem. Hierbei kommt der Non-24h-Schlaf-Wach-Rhythmusstörung (Non-24) in der Gruppe der Patienten ohne Lichtwahrnehmung eine besondere Bedeutung zu. Durch den Wegfall des stärksten externen Taktgebers Tageslicht kommt es zu einer Desynchronisation der endogenen circadianen Rhythmik, welche über die Masterclock im suprachiasmatischen Nucleus generiert wird, mit dem externen 24h-Tag-Nacht-Rhythmus. Die Ausschüttung von Melatonin, als wichtigster Botenstoff in der Regulation des Schlaf-Wach-Rhythmus, wird durch den Wegfall der Information über Helligkeit und Dunkelheit nicht mehr extern gesteuert und folgt allein der endogenen Rhythmik, welche häufig nicht exakt 24 Stunden entspricht, sondern bei den meisten Menschen eine längere Periodik aufweist. Die Symptome einer solchen fortlaufenden Verschiebung des Schlaf-Wach-Rhythmus beinhalten zyklisch wiederkehrende Phasen mit insomnischen Beschwerden und Tagesschläfrigkeit, welche mit symptomfreien Phasen alternieren. Die Diagnostik der Non-24 umfasst neben einer ausführlichen schlafspezifischen Anamnese auch die Durchführung einer Aktimetrie für einen Zeitraum von mindestens 2 Wochen und das Führen von Schlafprotokollen. Zudem kann die Messung von Biomarkern z. B. des Melatonins, im Serum oder Speichel, oder dessen Abbauprodukt zur Sicherung einer Diagnose sinnvoll sein.Als Therapieoptionen stehen nicht medikamentöse und medikamentöse Maßnahmen zur Verfügung, welche als Kombinationstherapie angewandt werden sollten. Aktuell ist der Melatonin-Rezeptoragonist Tasimelteon das einzige zugelassen Medikament zur Behandlung der Non-24 bei blinden Menschen.

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Yadlapalli, Siva Sankara Rao, Vijaya Kumari Karra, Vinutha Kommineni, Naresh Kumar Katari, and Surendra Babu Manabolu Surya. "Bioanalytical technique for determination of tasimelteon in human plasma by LC–MS/MS and its application to pharmacokinetic study in humans." Biomedical Chromatography 33, no. 3 (December 12, 2018): e4431. http://dx.doi.org/10.1002/bmc.4431.

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