{"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\/fr\/resource\/fda-issues-guidance-for-developing-abuse-deterrent-opioids\/","title":{"rendered":"La FDA publie des directives pour le d\u00e9veloppement d&#039;opio\u00efdes dissuasifs contre les abus"},"content":{"rendered":"<p>Cette semaine, la Food and Drug Administration (FDA) des \u00c9tats-Unis a publi\u00e9 des directives finales pour aider l&#039;industrie \u00e0 d\u00e9velopper des m\u00e9dicaments opio\u00efdes dot\u00e9s de propri\u00e9t\u00e9s potentiellement dissuasives.<\/p>\n<p>Pour lutter contre l&#039;abus et l&#039;abus d&#039;opio\u00efdes, la FDA encourage les fabricants \u00e0 d\u00e9velopper des m\u00e9dicaments dissuasifs qui fonctionnent correctement lorsqu&#039;ils sont pris comme prescrits, mais, par exemple, peuvent \u00eatre formul\u00e9s de mani\u00e8re \u00e0 dissuader l&#039;abus et l&#039;abus, notamment en rendant difficile le reniflement. ou injectez le m\u00e9dicament pour un high plus intense. Bien que les m\u00e9dicaments dot\u00e9s de propri\u00e9t\u00e9s dissuasives ne soient pas \u00ab\u00e0 l&#039;\u00e9preuve des abus\u00bb, la FDA consid\u00e8re ces directives comme une \u00e9tape importante vers l&#039;\u00e9quilibre entre l&#039;acc\u00e8s appropri\u00e9 aux opio\u00efdes pour les patients souffrant de douleur et l&#039;importance de r\u00e9duire l&#039;abus et l&#039;abus d&#039;opio\u00efdes.<\/p>\n<p>Le document <a href=\"https:\/\/www.fda.gov\/downloads\/Drugs\/GuidanceComplianceRegulatoryInformation\/Guidances\/UCM334743.pdf\" target=\"_blank\" rel=\"noopener\">\u00ab Orientations pour l&#039;industrie\u00a0: Opio\u00efdes dissuasifs contre l&#039;abus - \u00c9valuation et \u00e9tiquetage\u00a0\u00bb<\/a> explique la r\u00e9flexion actuelle de la FDA sur les \u00e9tudes qui devraient \u00eatre men\u00e9es pour d\u00e9montrer qu&#039;une formulation donn\u00e9e a des propri\u00e9t\u00e9s dissuasives d&#039;abus. Il formule \u00e9galement des recommandations sur la mani\u00e8re dont ces \u00e9tudes doivent \u00eatre r\u00e9alis\u00e9es et \u00e9valu\u00e9es, et discute des all\u00e9gations d&#039;\u00e9tiquetage qui peuvent \u00eatre approuv\u00e9es sur la base des r\u00e9sultats de ces \u00e9tudes.<\/p>\n<p>\u00ab\u00a0La science des m\u00e9dicaments anti-abus \u00e9volue rapidement et la FDA est impatiente de s&#039;engager avec les fabricants pour aider \u00e0 mettre ces m\u00e9dicaments \u00e0 la disposition des patients qui en ont besoin\u00a0\u00bb, a d\u00e9clar\u00e9 la commissaire de la FDA, Margaret A. Hamburg, MD. \u00ab\u00a0Nous pensons que c&#039;est une cl\u00e9. dans le cadre de la lutte contre l&#039;abus d&#039;opio\u00efdes. Nous devons travailler dur avec l&#039;industrie pour soutenir le d\u00e9veloppement de nouvelles formulations difficiles \u00e0 abuser mais efficaces et disponibles en cas de besoin.<\/p>\n<p><strong>VOIR \u00c9GALEMENT:<\/strong><\/p>\n<p><a href=\"https:\/\/www.cadca.org\/fr\/blog\/preventing-prescription-drug-abuse-possible\/\" target=\"_blank\" rel=\"noopener\">Pr\u00e9venir l&#039;abus de m\u00e9dicaments sur ordonnance est possible<\/a><\/p>\n<p><a href=\"https:\/\/www.cadca.org\/fr\/resources\/markey-ayotte-introduce-bipartisan-legislation-help-prevent-heroin-and-prescription-drug\/\" target=\"_blank\" rel=\"noopener\">Markey et Ayotte pr\u00e9sentent une l\u00e9gislation bipartite pour aider \u00e0 pr\u00e9venir les surdoses d&#039;h\u00e9ro\u00efne et de m\u00e9dicaments sur ordonnance<\/a><\/p>","protected":false},"excerpt":{"rendered":"<p>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":"<!-- This site is optimized with the Yoast SEO plugin v27.4 - https:\/\/yoast.com\/product\/yoast-seo-wordpress\/ -->\n<title>FDA 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\/fr\/resource\/fda-issues-guidance-for-developing-abuse-deterrent-opioids\/\" \/>\n<meta property=\"og:locale\" content=\"fr_FR\" \/>\n<meta property=\"og:type\" content=\"article\" \/>\n<meta property=\"og:title\" content=\"FDA Issues 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