{"id":17884,"date":"2015-04-02T00:00:00","date_gmt":"2015-04-02T00:00:00","guid":{"rendered":"https:\/\/cadca1stg.wpengine.com\/resource\/fda-issues-guidance-for-developing-abuse-deterrent-opioids\/"},"modified":"2023-10-12T18:57:33","modified_gmt":"2023-10-12T18:57:33","slug":"fda-issues-guidance-for-developing-abuse-deterrent-opioids","status":"publish","type":"resource","link":"https:\/\/www.cadca.org\/es\/resource\/fda-issues-guidance-for-developing-abuse-deterrent-opioids\/","title":{"rendered":"La FDA publica una gu\u00eda para desarrollar opioides que disuadan el abuso"},"content":{"rendered":"

Esta semana, la Administraci\u00f3n de Alimentos y Medicamentos de EE. UU. (FDA) emiti\u00f3 una gu\u00eda final para ayudar a la industria a desarrollar productos farmacol\u00f3gicos opioides con propiedades potencialmente disuasorias del abuso.<\/p>\n

Para combatir el uso indebido y el abuso de opioides, la FDA est\u00e1 alentando a los fabricantes a desarrollar medicamentos disuasorios del abuso que funcionen correctamente cuando se toman seg\u00fan lo recetado, pero que, por ejemplo, pueden formularse de tal manera que disuadan el uso indebido y el abuso, incluso dificultando su inhalaci\u00f3n. o inyectar la droga para obtener un subid\u00f3n m\u00e1s intenso. Si bien los medicamentos con propiedades disuasorias del abuso no son \u201ca prueba de abuso\u201d, la FDA considera esta gu\u00eda como un paso importante para equilibrar el acceso apropiado a los opioides para pacientes con dolor con la importancia de reducir el uso indebido y el abuso de opioides.<\/p>\n

El documento \u201cGu\u00eda para la industria: Opioides que disuaden el abuso \u2013 Evaluaci\u00f3n y etiquetado\u201d<\/a> explica el pensamiento actual de la FDA sobre los estudios que deben realizarse para demostrar que una formulaci\u00f3n determinada tiene propiedades disuasorias del abuso. Tambi\u00e9n hace recomendaciones sobre c\u00f3mo se deben realizar y evaluar esos estudios, y analiza qu\u00e9 afirmaciones de etiquetado pueden aprobarse en funci\u00f3n de los resultados de esos estudios.<\/p>\n

"La ciencia de los medicamentos disuasorios del abuso est\u00e1 evolucionando r\u00e1pidamente y la FDA est\u00e1 ansiosa por colaborar con los fabricantes para ayudar a que estos medicamentos est\u00e9n disponibles para los pacientes que los necesitan", dijo la comisionada de la FDA, Margaret A. Hamburg, MD. "Creemos que este es un paso clave". parte de la lucha contra el abuso de opioides. Tenemos que trabajar duro con la industria para apoyar el desarrollo de nuevas formulaciones que sean dif\u00edciles de abusar pero que sean efectivas y est\u00e9n disponibles cuando sea necesario\u201d.<\/p>\n

VER TAMBI\u00c9N:<\/strong><\/p>\n

Es posible prevenir el abuso de medicamentos recetados<\/a><\/p>\n

Markey y Ayotte presentan legislaci\u00f3n bipartidista para ayudar a prevenir las sobredosis de hero\u00edna y medicamentos recetados<\/a><\/p>","protected":false},"excerpt":{"rendered":"

This week, the U.S. Food and Drug Administration (FDA) issued final guidance to assist industry in developing opioid drug products<\/p>","protected":false},"author":23,"featured_media":0,"template":"","resource_type":[281],"drug_specific_issues":[312,307],"action_to_do":[],"class_list":["post-17884","resource","type-resource","status-publish","hentry","resource_type-coalitions-online","drug_specific_issues-heroin","drug_specific_issues-prescription-and-over-the-counter-medications"],"acf":[],"yoast_head":"\nFDA Issues Guidance for Developing Abuse-Deterrent Opioids | CADCA<\/title>\n<meta name=\"robots\" content=\"index, follow, max-snippet:-1, max-image-preview:large, max-video-preview:-1\" \/>\n<link rel=\"canonical\" href=\"https:\/\/www.cadca.org\/es\/resource\/fda-issues-guidance-for-developing-abuse-deterrent-opioids\/\" \/>\n<meta property=\"og:locale\" content=\"es_ES\" \/>\n<meta property=\"og:type\" content=\"article\" \/>\n<meta property=\"og:title\" content=\"FDA Issues 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