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Rizmoic® - Wirkstoff Naldemedin (PAMORA - peripher wirkende μ-Opioidrezeptor-Antagonisten)

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Naldemedin|Rizmoic®|60|2020

Pharmazeutische Zeitung, 29.05.2020

https://www.pharmazeutische-zeitung.de/arzneistoffe/daten/2020/naldemedinrizmoicr602020/

Neue Arzneimittel: Naldemedin (Rizmoic®) 

Zugelassene Indikation und Wirkmechanismus

Rizmoic® (Naldemedin) ist zur Behandlung von opioidinduzierter Obstipation (OIC, opioid-induced constipation) bei Erwachsenen zugelassen, die früher bereits mit einem Abführmittel behandelt wurden. Naldemedin ist ein Naltrexon-Derivat, das chemisch so verändert wurde, dass es die Blut-Hirn-Schranke nicht überqueren kann. Zudem ist Naldemedin ein Substrat des P-Glykoprotein (P-gp)-Effluxtransporters, der möglicherweise ebenfalls dazu beiträgt, dass Naldemedin nicht in das ZNS eindringt. Naldemedin antagonisiert die Opioid-Bindung an den µ-, δ- und κ-Opioidrezeptoren im Gastrointestinaltrakt und vermindert dadurch die obstipierenden Wirkungen von Opioiden ohne die ZNS-vermittelten Opioideffekte aufzuheben. Der pharmazeutische Unternehmer gab bei der Zulassung an, dass Naldemedin aufgrund seiner langsamen Assoziations- und Dissoziationskinetik am μ-Opioidrezeptor vermutlich als nicht kompetitiver Antagonist wirkt, sodass die antagonistische Wirkung auch bei höheren Opioidkonzentrationen aufrechterhalten bleibt. Diese Annahme basierte auf Ergebnissen präklinischer Studien. Der Ausschuss für Humanarzneimittel der EMA beschrieb im European Public Assessment Report Naldemedin aber eher als kompetitiver Antagonist, sodass ein sogenannter Ceiling-Effekt nicht ausgeschlossen werden kann.

Arzneimittelkommission der deutschen Ärzteschaft, 22.06.2020

https://www.akdae.de/Arzneimitteltherapie/AVP/Artikel/2020-3-4/129h/index.php

Elevated body fat increases amphetamine accumulation in brain: evidence from genetic and diet-induced forms of adiposity. 

Fu X, Shah AP, Keighron J, Mou TM, Ladenheim B, Alt J, Fukudome D, Niwa M, Tamashiro KL, Tanda G, Sawa A, Cadet JL, Rais R, Baraban JM. 

Transl Psychiatry. 2021 Aug 14;11(1):427. doi: 10.1038/s41398-021-01547-9. PMID: 34392304; PMCID: PMC8364554.

https://www.ncbi.nlm.nih.gov/pmc/articles/PMC8364554/

A Systematic Review of Opioid Use Disorder and Related Biomarkers. 

Bryant BM, Eaton E, Li L. 

Front Psychiatry. 2021 Aug 11;12:708283. doi: 10.3389/fpsyt.2021.708283. PMID: 34456765; PMCID: PMC8385272.

https://www.ncbi.nlm.nih.gov/pmc/articles/PMC8385272/

Clostridium botulinum Type B Isolated From a Wound Botulism Case Due to Injection Drug Use Resembles Other Local Strains Originating From Hawaii. 

Halpin JL, Foltz V, Dykes JK, Chatham-Stephens K, Lúquez C. 

Front Microbiol. 2021 Jul 22;12:678473. doi: 10.3389/fmicb.2021.678473. PMID: 34367084; PMCID: PMC8339428.

https://www.ncbi.nlm.nih.gov/pmc/articles/PMC8339428/

Cognitive Impairment in Opium Use Disorder. 

Sanjari Moghaddam H, Shadloo B, Shahkhah H, Tafakhori A, Haghshomar M, Meshkat S, Aghamollaii V. 

Behav Neurol. 2021 Jul 30;2021:5548623. doi: 10.1155/2021/5548623. PMID: 34373762; PMCID: PMC8349248.

https://www.ncbi.nlm.nih.gov/pmc/articles/PMC8349248/

Oral health-related quality of life among a group of patients with substance use disorders in rehabilitation treatment: a cross-sectional study. 

Amiri S, Shekarchizadeh H. 

BMC Oral Health. 2021 Aug 19;21(1):409. doi: 10.1186/s12903-021-01764-0. PMID: 34412608; PMCID: PMC8377868.

https://bmcoralhealth.biomedcentral.com/articles/10.1186/s12903-021-01764-0

Polyvinylpyrrolidone deposition disease in patients with intravenous opioid use: a case series. 

Leh F, Stalund IV, Bjånes TK, Ohldieck C, Svarstad E, Leh S.

Hum Pathol. 2021 Jul 27:S0046-8177(21)00130-1. doi: 10.1016/j.humpath.2021.07.009. Epub ahead of print. PMID: 34329652.

Abstract

https://www.sciencedirect.com/science/article/abs/pii/S0046817721001301

Case Report: Polyvinylpyrrolidone deposition disease from repeated injection of opioid substitution drugs: report of a case with a fatal outcome. 

Stalund IV, Riise GN, Leh F, Bjånes TK, Riise L, Svarstad E, Leh S. 

F1000Res. 2021 Apr 19;10:300. doi: 10.12688/f1000research.51927.2. PMID: 34316359; PMCID: PMC8276182.

https://www.ncbi.nlm.nih.gov/pmc/articles/PMC8276182/

Chronic opioid use modulates human enteric microbiota and intestinal barrier integrity. 

Cruz-Lebrón A, Johnson R, Mazahery C, Troyer Z, Joussef-Piña S, Quiñones-Mateu ME, Strauch CM, Hazen SL, Levine AD. 

Gut Microbes. 2021 Jan-Dec;13(1):1946368. doi: 10.1080/19490976.2021.1946368. PMID: 34313547; PMCID: PMC8317955.

https://www.ncbi.nlm.nih.gov/pmc/articles/PMC8317955/

Psychosis after buprenorphine, heroin, methadone, morphine, oxycodone, and tramadol withdrawal: a systematic review. 

Lozano-López MT, Gamonal-Limcaoco S, Casado-Espada N, Aguilar L, Vicente-Hernández B, Grau-López L, Álvarez-Navares A, Roncero C. 

Eur Rev Med Pharmacol Sci. 2021 Jul;25(13):4554-4562. doi: 10.26355/eurrev_202107_26248. PMID: 34286498.

https://pubmed.ncbi.nlm.nih.gov/34286498/

Hearing status in patients with overdose of illicit drugs.

Mokhtarinejad F, Peyvandi AA, Shadnia S, Peyvandi H, Rezvani M, Khoshsirat S, Oroei M. 

Med J Islam Repub Iran. 2021 May 1;35:56. doi: 10.47176/mjiri.35.56. PMID: 34268244; PMCID: PMC8271270.

https://www.ncbi.nlm.nih.gov/pmc/articles/PMC8271270/

Cranial Nerve Palsy Secondary to Botulism After Black Tar Heroin Use. 

Suzuki HT, Reddy H. 

J Am Board Fam Med. 2021 Jul-Aug;34(4):808-810. doi: 10.3122/jabfm.2021.04.200644. PMID: 34312272.

https://www.jabfm.org/content/34/4/808.long

Clostridium botulinum - like organism bacteremia in a user of black tar heroin. 

Battiola T, Saad K, Nelson T, Tinker N, Crosby A. 

IDCases. 2021 Jul 9;25:e01222. doi: 10.1016/j.idcr.2021.e01222. PMID: 34295646; PMCID: PMC8282946.

https://www.ncbi.nlm.nih.gov/pmc/articles/PMC8282946/

Heroin-Induced Acute Pancreatitis. 

Ciobanu C, Jadav RS, Colon Ramos A, Sequeira Gross HG, Brazzarola C. 

Cureus. 2021 Jun 5;13(6):e15470. doi: 10.7759/cureus.15470. PMID: 34262808; PMCID: PMC8260205.

https://www.ncbi.nlm.nih.gov/pmc/articles/PMC8260205/

Wound Botulism in Black Tar Heroin Injecting Users: A Case Series. 

Raza N, Dhital S, Espinoza VE, Jariwal R, Chiu CW, Valdez M, Heidari A, Petersen G, Sabetian K. 

J Investig Med High Impact Case Rep. 2021 Jan-Dec;9:23247096211028078. doi: 10.1177/23247096211028078. PMID: 34259080; PMCID: PMC8283217.

https://www.ncbi.nlm.nih.gov/pmc/articles/PMC8283217/

Posterior Reversible Encephalopathy Syndrome (PRES) in a Patient with Opioid Use Disorder. 

Tumenta T, Adeyemo S, Oladeji O, Jegede O, Laurent B, Olupona T. 

Case Rep Psychiatry. 2021 Jun 16;2021:9999481. doi: 10.1155/2021/9999481. PMID: 34221530; PMCID: PMC8225411.

https://www.hindawi.com/journals/crips/2021/9999481/

Neural basis of opioid-induced respiratory depression and its rescue

Shijia Liu, Dong-Il Kim, Tae Gyu Oh, Gerald M. Pao, Jong-Hyun Kim, Richard D. Palmiter, Matthew R. Banghart, Kuo-Fen Lee, Ronald M. Evans, Sung Han

Proceedings of the National Academy of Sciences Jun 2021, 118 (23) e2022134118; DOI: 10.1073/pnas.2022134118 

https://www.pnas.org/content/118/23/e2022134118

Trends in the prevalence and incidence of anxiety and depressive symptoms in Iran: findings from KERCADRS. 

Najafipour H, Shahrokhabadi MS, Banivaheb G, Sabahi A, Shadkam M, Mirzazadeh A 

Fam Med Community Health. 2021 Jul;9(3):e000937. doi: 10.1136/fmch-2021-000937. PMID: 34215671; PMCID: PMC8256739.

https://www.ncbi.nlm.nih.gov/pmc/articles/PMC8256739/

The Safety and Effectiveness of Pharmacotherapy for Opioid-Overdose Induced Aspiration Pneumonia in a Referral Poisoning Management University Hospital in Iran. 

Tabatabaei M, Dorvashy G, Soltani R, Samsamshariat S, Meamar R, Sabzghabaee AM. 

J Res Pharm Pract. 2021 May 13;10(1):38-42. doi: 10.4103/jrpp.JRPP_21_17. PMID: 34295851; PMCID: PMC8259600.

https://www.ncbi.nlm.nih.gov/pmc/articles/PMC8259600/

Infective endocarditis with embolic renal infarct presenting as acute abdomen. 

Eid MM. 

Clin Exp Emerg Med. 2021 Jun;8(2):145-148. doi: 10.15441/ceem.20.037. Epub 2021 Jun 30. PMID: 34237820; PMCID: PMC8273678.

https://www.ncbi.nlm.nih.gov/pmc/articles/PMC8273678/

Acute suppurative thyroiditis seeded from infective endocarditis and intravenous drug use. 

Cheung B, Levy C, Cheung M, Dhanaraja A, Abraham R, Duvoor C. 

IDCases. 2021 Jul 7;25:e01221. doi: 10.1016/j.idcr.2021.e01221. PMID: 34295645; PMCID: PMC8282969.

https://www.ncbi.nlm.nih.gov/pmc/articles/PMC8282969/

Heroin Relapse "Strikes a Nerve": A Rare Case of Drug-Induced Acute Myelopathy. 

Sidhu MK, Mekala AP, Ronen JA, Hamdan A, Mungara SS. 

Cureus. 2021 Jun 23;13(6):e15865. doi: 10.7759/cureus.15865. PMID: 34327090; PMCID: PMC8301723.

https://www.ncbi.nlm.nih.gov/pmc/articles/PMC8301723/

The Link between Cannabis Use, Immune System, and Viral Infections. 

Maggirwar SB, Khalsa JH. 

Viruses. 2021 Jun 9;13(6):1099. doi: 10.3390/v13061099. PMID: 34207524; PMCID: PMC8229290.

https://www.ncbi.nlm.nih.gov/pmc/articles/PMC8229290/

Methamphetamine-related cardiovascular diseases. 

Schwarzbach V, Lenk K, Laufs U. 

ESC Heart Fail. 2020 Apr;7(2):407-414. doi: 10.1002/ehf2.12572. Epub 2020 Jan 17. PMID: 31950731; PMCID: PMC7160483.

https://www.ncbi.nlm.nih.gov/pmc/articles/PMC7160483/

Effects of Psychopathy on Neurocognitive Domains of Impulsivity in Abstinent Opiate and Stimulant Users. 

Psederska E, Thomson ND, Bozgunov K, Nedelchev D, Vasilev G, Vassileva J. 

Front Psychiatry. 2021 Jun 9;12:660810. doi: 10.3389/fpsyt.2021.660810. PMID: 34177649; PMCID: PMC8219927.

https://www.ncbi.nlm.nih.gov/pmc/articles/PMC8219927/

Blood Lead Levels, Hemoglobin, and Liver Enzymes in Opium-Dependent Addicts. 

Montazerifar F, Karajibani M, Lashkaripour M, Sayyad Mollashahi M, Niazi AA, Soltan Mohammadi M, Rahimi Helari S. 

Int J Prev Med. 2021 Jan 19;12:3. doi: 10.4103/ijpvm.IJPVM_303_18. PMID: 34084300; PMCID: PMC8106272.

https://www.ncbi.nlm.nih.gov/pmc/articles/PMC8106272/

A review of sleep disturbance in adults prescribed medications for opioid use disorder: potential treatment targets for a highly prevalent, chronic problem. 

Wilkerson AK, McRae-Clark AL. 

Sleep Med. 2021 May 27;84:142-153. doi: 10.1016/j.sleep.2021.05.021. Epub ahead of print. PMID: 34153796.

Abstract

https://pubmed.ncbi.nlm.nih.gov/34153796/

Opioid use disorder and the brain: a clinical perspective.

Herlinger, K., and Lingford-Hughes, A. (2021) 

Addiction, doi.org/10.1111/add.15636.

https://onlinelibrary.wiley.com/doi/abs/10.1111/add.15636