Reposicionamiento de fármacos: beneficios e inconvenientes
DOI:
https://doi.org/10.29105/qh13.04-454Palabras clave:
Reposicionamiento de fármacos, Patentes, Industria Farmacéutica, Producto Biológico, Investigación ClínicaResumen
La industria farmacéutica está tomando el reposicionamiento de fármacos como una aproximación novedosa para sacar al mercado medicamentos. En términos simples este proceso está basado en el reperfilamiento de fármacos que por alguna razón fueron abandonados o archivados, ya que durante su descubrimiento y desarrollo presentaron algún inconveniente para que fueran lanzados al público. Sin embargo, estas moléculas son retomadas posteriormente ya que se les ha encontrado una nueva aplicación clínica. Es decir, el reposicionamiento es una estrategia en la que medicamentos que ya están aprobados o, en proceso de investigación clínica y encuentran una nueva aplicación terapéutica diferente a la propuesta originalmente. En esta revisión se hace un recuento de los beneficios y desventajas que se observan a lo largo de un proceso de reposicionamiento. Se describe todos los posibles aspectos que deben abordarse durante el reposicionamiento de un fármaco; desde el punto de vista legal (principalmente patentes), asimismo desde el punto de vista técnico y clínico.
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- [1]. A. Wadud, P. V. Prasad, M.M. Rao, A. Narayana, Evolution of drug: a historical perspective., Bull. Indian Inst. Hist. Med. Hyderabad. 37 (2007) 69–80.
- [2]. D. Taylor, The Pharmaceutical Industry and the Future of Drug Development, in: R.E. Hester;, R.M. Harrison (Eds.), Pharm. Environ., Royal Society of Chemistry, 2016: pp. 1–33. https://doi.org/10.1039/9781782622345-00001. DOI: https://doi.org/10.1039/9781782622345-00001
- [3]. C.P. Adams, V. Van Brantner, Market watch : Estimating the cost of new drug development: Is it really $802 million?, Health Aff. 25 (2006) 420–428. https://doi.org/10.1377/hlthaff.25.2.420. DOI: https://doi.org/10.1377/hlthaff.25.2.420
- [4]. FDA. (2018). https://www.fda.gov/patients/learn-about-drug-and-device-approvals/drug-development-process, (n.d.).
- [5]. D.C. Swinney, J. Anthony, How were new medicines discovered?, Nat. Rev. Drug Discov. 10 (2011) 507–519. https://doi.org/10.1038/nrd3480. DOI: https://doi.org/10.1038/nrd3480
- [6]. González Andrade, Fabricio (Ed.). (2017). Medicamentos biológicos: presente y futuro de la terapéutica. Quito: Litocolor., n.d.
- [7]. J. Eder, R. Sedrani, C. Wiesmann, The discovery of first-in-class drugs: origins and evolution, Nat. Rev. Drug Discov. 13 (2014) 577–587. https://doi.org/10.1038/nrd4336. DOI: https://doi.org/10.1038/nrd4336
- [8]. Juan Roldán, Farmacovigilancia: Datos Sobre El Estado Actual De Esta Disciplina En Chile, Rev. Médica Clínica Las Condes. 27 (2016) 585–593. https://doi.org/10.1016/j.rmclc.2016.09.003. DOI: https://doi.org/10.1016/j.rmclc.2016.09.003
- [9]. A. Tuffs, Thalidomide: the true story?, BMJ. 334 (2007) 933. https://doi.org/10.1136/bmj.39199.637986.59. DOI: https://doi.org/10.1136/bmj.39199.637986.59
- [10]. G. Fornasier, S. Francescon, R. Leone, P. Baldo, An historical overview over Pharmacovigilance, Int. J. Clin. Pharm. 40 (2018) 744–747. https://doi.org/10.1007/s11096-018-0657-1. DOI: https://doi.org/10.1007/s11096-018-0657-1
- [11]. P. Wright, Untoward Effects Associated with Practolol Administration: Oculomucocutaneous Syndrome, Br. Med. J. 1 (1975) 595–598. https://doi.org/10.1136/bmj.1.5958.595. DOI: https://doi.org/10.1136/bmj.1.5958.595
- [12]. N.S. Zubiran, P. Halsey, N. Cardoe, Benoxaprofen: side-effect profile, 284 (1982). DOI: https://doi.org/10.1136/bmj.284.6326.1365
- [13]. Furberg C, Pitt B, Withdrawal of cerivastatin from the world market, Curr. Control. Trials Cardiovasc. Med. 2 (2001) 205–207. http://cvm.controlled-trials.com/content/2/5/205. DOI: https://doi.org/10.1186/cvm-2-5-205
- [14]. K.B. Pouwels, K. Van Grootheest, The rosiglitazone decision process at FDA and EMA. What should we learn?, Int. J. Risk Saf. Med. 24 (2012) 73–80. https://doi.org/10.3233/JRS-2012-0559. DOI: https://doi.org/10.3233/JRS-2012-0559
- [15]. D.J. Graham, R. Ouellet-Hellstrom, T.E. Macurdy, F. Ali, C. Sholley, C. Worrall, J.A. Kelman, Risk of acute myocardial infarction, stroke, heart failure, and death in elderly medicare patients treated with rosiglitazone or pioglitazone, Jama. 304 (2010) 411–418. https://doi.org/10.1001/jama.2010.920. DOI: https://doi.org/10.1001/jama.2010.920
- [16]. M.W. Sajewycz, Patent protection strategies, J. Pharm. Bioallied Sci. 2 (2010) 2–7. https://doi.org/10.4103/0975-7406.62694. DOI: https://doi.org/10.4103/0975-7406.62694
- [17]. P.M. Webber, Protecting your inventions: The patent system, Nat. Rev. Drug Discov. 2 (2003) 823–830. https://doi.org/10.1038/nrd1200. DOI: https://doi.org/10.1038/nrd1200
- [18]. C. Orrego Gómez, P. Jaramillo Velázquez, Posibilidad de patentar métodos de diagnóstico, terapéuticos y quirúrgicos y sus segundos usos en Colombia después de la entrada en vigencia del tratado de libre comercio entre Colombia y Estados Unidos. (Tesis, Pontificia Universidad Javeriana, Bogota), 2013.
- [19]. A. V. Trask, An overview of pharmaceutical cocrystals as intellectual property, Mol. Pharm. 4 (2007) 301–309. https://doi.org/10.1021/mp070001z. DOI: https://doi.org/10.1021/mp070001z
- [20]. M. Solares-Briones, G. Coyote-Dotor, J.C. Páez-Franco, M.R. Zermeño-Ortega, Ca.M. de la O Contreras, D. Canseco-González, A. Avila-Sorrosa, D. Morales-Morales, J.M. Germán-Acacio, Mechanochemistry : A Green Approach in the Preparation of Pharmaceutical Cocrystals, Pharmaceutics. 13 (2021) 790. https://doi.org/10.3390/pharmaceutics13060790. DOI: https://doi.org/10.3390/pharmaceutics13060790
- [21]. B. Dejan-Krešimir, R.W. Lancaster, J. Bernstein, Disappearing Polymorphs Revisited, Angew. Chemie - Int. Ed. 54 (2015) 6972–6993. https://doi.org/10.1002/anie.201410356. DOI: https://doi.org/10.1002/anie.201410356
- [22]. B.T. Law, Journal, Annual Review of Law and Technology, Berkeley Technol. Law J. 24 (2009) 1–719.
- [23]. S. Narala, D. Nyavanandi, P. Srinivasan, P. Mandati, S. Bandari, M.A. Repka, Pharmaceutical Co-crystals, Salts, and Co-amorphous Systems: A novel opportunity of hot-melt extrusion, J. Drug Deliv. Sci. Technol. 61 (2021) 102209. https://doi.org/10.1016/j.jddst.2020.102209. DOI: https://doi.org/10.1016/j.jddst.2020.102209
- [24]. J. Haneef, S. Ali, R. Chadha, Emerging Multi-Drug Eutectics: Opportunities and Challenges, AAPS PharmSciTech. 22 (2021) 66. https://doi.org/10.1208/s12249-021-01939-6. DOI: https://doi.org/10.1208/s12249-021-01939-6
- [25]. D. Cataldo, Batalla De Los Países En Desarrollo, (2003) 123–137.
- [26]. S. Pushpakom, F. Iorio, P.A. Eyers, K.J. Escott, S. Hopper, A. Wells, A. Doig, T. Guilliams, J. Latimer, C. McNamee, A. Norris, P. Sanseau, D. Cavalla, M. Pirmohamed, Drug repurposing: Progress, challenges and recommendations, Nat. Rev. Drug Discov. 18 (2018) 41–58. https://doi.org/10.1038/nrd.2018.168. DOI: https://doi.org/10.1038/nrd.2018.168
- [27]. V.S. Kulkarni, V. Alagarsamy, V.R. Solomon, P.A. Jose, S. Murugesan, Drug Repurposing: An Effective Tool in Modern Drug Discovery, Russ. J. Bioorganic Chem. 49 (2023) 157–166. https://doi.org/10.1134/S1068162023020139. DOI: https://doi.org/10.1134/S1068162023020139
- [28]. M. Aboy, K. Liddell, M. Jordan, C. Crespo, J. Liddicoat, European patent protection for medical uses of known products and drug repurposing, Nat. Biotechnol. 40 (2022) 465–471. https://doi.org/10.1038/s41587-022-01269-3. DOI: https://doi.org/10.1038/s41587-022-01269-3
- [29]. T.T. Ashburn, K.B. Thor, Drug repositioning: Identifying and developing new uses for existing drugs, Nat. Rev. Drug Discov. 3 (2004) 673–683. https://doi.org/10.1038/nrd1468. DOI: https://doi.org/10.1038/nrd1468
- [30]. V. Pannikar, The return of thalidomide: new uses and renewed concerns, Lepr. Rev. 74 (2003) 286–293. https://doi.org/10.47276/lr.74.3.286. DOI: https://doi.org/10.47276/lr.74.3.286
- [31]. B.M. Sahoo, B.V.V. Ravi Kumar, J. Sruti, M.K. Mahapatra, B.K. Banik, P. Borah, Drug Repurposing Strategy (DRS): Emerging Approach to Identify Potential Therapeutics for Treatment of Novel Coronavirus Infection, Front. Mol. Biosci. 8 (2021) 1–11. https://doi.org/10.3389/fmolb.2021.628144. DOI: https://doi.org/10.3389/fmolb.2021.628144
- [32]. Y. Acharya, A. Sayed, Chloroquine and hydroxychloroquine as a repurposed agent against COVID-19: a narrative review, Ther. Adv. Vaccines. 7 (2020) 1–14. https://doi.org/10.1177/2049936120947517. DOI: https://doi.org/10.1177/2049936120947517
- [33]. Minesoft (2024). https://minesoft.com/can-you-patent-a-process-everything-you-need-to-know/, (n.d.).
- [34]. American Association For the Advancement of Science (2024). https://www.eurekalert.org/news-releases/565901, (n.d.).
- [35]. X. Xie, Y. Tang, Efficient synthesis of simvastatin by use of whole-cell biocatalysis, Appl. Environ. Microbiol. 73 (2007) 2054–2060. https://doi.org/10.1128/AEM.02820-06. DOI: https://doi.org/10.1128/AEM.02820-06
- [36]. J.A. DiMasi, R.W. Hansen, H.G. Grabowski, The price of innovation: New estimates of drug development costs, J. Health Econ. 22 (2003) 151–185. https://doi.org/10.1016/S0167-6296(02)00126-1. DOI: https://doi.org/10.1016/S0167-6296(02)00126-1
- [37]. A. Schuhmacher, M. Hinder, A. von Stegmann und Stein, D. Hartl, O. Gassmann, Analysis of pharma R&D productivity – a new perspective needed, Drug Discov. Today. 28 (2023) 103726. https://doi.org/10.1016/j.drudis.2023.103726. DOI: https://doi.org/10.1016/j.drudis.2023.103726
- [38]. J. Drews, Stategic trends in the drug industry, Drug Discov. Today. 8 (2003) 411–20. http://www.ncbi.nlm.nih.gov/pubmed/12706659. DOI: https://doi.org/10.1016/S1359-6446(03)02690-4
- [39]. P. Imming, C. Sinning, A. Meyer, Drugs, their targets and the nature and number of drug targets, Nat. Rev. Drug Discov. 5 (2006) 821–834. https://doi.org/https://doi.org/10.1038/nrd2132. DOI: https://doi.org/10.1038/nrd2132
- [40]. M.A. Yıldırım, K.-I. Goh, M.E. Cusick, A.-L. Barabási, M. Vidal, Drug—target network, Nat. Biotechnol. 25 (2007) 1119–1126. https://doi.org/10.1038/nbt1338. DOI: https://doi.org/10.1038/nbt1338
- [41]. K. Gallo, A. Goede, A. Eckert, B. Moahamed, R. Preissner, B.O. Gohlke, PROMISCUOUS 2.0: A resource for drug-repositioning, Nucleic Acids Res. 49 (2021) D1373–D1380. https://doi.org/10.1093/nar/gkaa1061. DOI: https://doi.org/10.1093/nar/gkaa1061
- [42]. J.J. Hernandez, M. Pryszlak, L. Smith, C. Yanchus, N. Kurji, V.M. Shahani, S. V. Molinski, Giving drugs a second chance: Overcoming regulatory and financial hurdles in repurposing approved drugs as cancer therapeutics, Front. Oncol. 7 (2017) 1–8. https://doi.org/10.3389/fonc.2017.00273. DOI: https://doi.org/10.3389/fonc.2017.00273
- [43]. N. Rao, T. Poojari, C. Poojary, R. Sande, S. Sawant, DRUG REPURPOSING : A SHORTCUT TO NEW BIOLOGICAL ENTITIES, Pharm. Chem. J. 56 (2022) 1203–1214. https://doi.org/10.1007/s11094-022-02778-w. DOI: https://doi.org/10.1007/s11094-022-02778-w
- [44]. N. Krishnamurthy, A.A. Grimshaw, S.A. Axson, S.H. Choe, J.E. Miller, Drug repurposing : a systematic review on root causes , barriers and facilitators, BMC Health Serv. Res. 22 (2022) 970. https://doi.org/10.1186/s12913-022-08272-z. DOI: https://doi.org/10.1186/s12913-022-08272-z
- [45]. G. Jin, S.T.C. Wong, Toward better drug repositioning: Prioritizing and integrating existing methods into efficient pipelines, Drug Discov. Today. 19 (2014) 637–644. https://doi.org/10.1016/j.drudis.2013.11.005. DOI: https://doi.org/10.1016/j.drudis.2013.11.005
- [46]. J. Langedijk, A.K. Mantel-Teeuwisse, D.S. Slijkerman, M.H.D.B. Schutjens, Drug repositioning and repurposing: terminology and definitions in literature, Drug Discov. Today. 20 (2015) 1027–1034. https://doi.org/10.1016/j.drudis.2015.05.001. DOI: https://doi.org/10.1016/j.drudis.2015.05.001
- [47]. L. Pinzi, N. Bisi, G. Rastelli, How drug repurposing can advance drug discovery: challenges and opportunities, Front. Drug Discov. 4 (2024) 1–9. https://doi.org/10.3389/fddsv.2024.1460100. DOI: https://doi.org/10.3389/fddsv.2024.1460100
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Derechos de autor 2025 Juan Manuel Germán Acacio, José Carlos Páez Franco, Irvin Jesús Moctezuma García, Víctor Manuel Martínez Cisneros, Guadalupe Coyote Dotor, Gloria Catalina Bernal Carrillo, Guillermo Roura Pérez, Jesús Ricardo Parra Unda
Esta obra está bajo una licencia internacional Creative Commons Atribución 4.0.
