{"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\/ru\/resource\/fda-issues-guidance-for-developing-abuse-deterrent-opioids\/","title":{"rendered":"FDA Issues Guidance for Developing Abuse-Deterrent Opioids"},"content":{"rendered":"<p>This week, the U.S. Food and Drug Administration (FDA) issued final guidance to assist industry in developing opioid drug products with potentially abuse-deterrent properties.<\/p>\n<p>To combat opioid misuse and abuse, the FDA is encouraging manufacturers to develop abuse-deterrent drugs that work correctly when taken as prescribed, but, for example, may be formulated in such a way that deters misuse and abuse, including making it difficult to snort or inject the drug for a more intense high. While drugs with abuse-deterrent properties are not \u201cabuse-proof,\u201d the FDA sees this guidance as an important step toward balancing appropriate access to opioids for patients with pain with the importance of reducing opioid misuse and abuse.<\/p>\n<p>The document <a href=\"https:\/\/www.fda.gov\/downloads\/Drugs\/GuidanceComplianceRegulatoryInformation\/Guidances\/UCM334743.pdf\" target=\"_blank\" rel=\"noopener\">\u201cGuidance for Industry: Abuse-Deterrent Opioids \u2013 Evaluation and Labeling\u201d<\/a> explains the FDA\u2019s current thinking about the studies that should be conducted to demonstrate that a given formulation has abuse-deterrent properties. It also makes recommendations about how those studies should be performed and evaluated, and discusses what labeling claims may be approved based on the results of those studies.<\/p>\n<p>\u201cThe science of abuse-deterrent medication is rapidly evolving, and the FDA is eager to engage with manufacturers to help make these medications available to patients who need them,\u201d said FDA Commissioner Margaret A. Hamburg, M.D. \u201cWe feel this is a key part of combating opioid abuse. We have to work hard with industry to support the development of new formulations that are difficult to abuse but are effective and available when needed.\u201d<\/p>\n<p><strong>\u0421\u041c\u041e\u0422\u0420\u0418\u0422\u0415 \u0422\u0410\u041a\u0416\u0415:<\/strong><\/p>\n<p><a href=\"https:\/\/www.cadca.org\/ru\/blog\/preventing-prescription-drug-abuse-possible\/\" target=\"_blank\" rel=\"noopener\">Preventing Prescription Drug Abuse is Possible<\/a><\/p>\n<p><a href=\"https:\/\/www.cadca.org\/ru\/resources\/markey-ayotte-introduce-bipartisan-legislation-help-prevent-heroin-and-prescription-drug\/\" target=\"_blank\" rel=\"noopener\">\u041c\u0430\u0440\u043a\u0438 \u0438 \u0410\u0439\u043e\u0442\u0442 \u043f\u0440\u0435\u0434\u0441\u0442\u0430\u0432\u043b\u044f\u044e\u0442 \u0434\u0432\u0443\u0445\u043f\u0430\u0440\u0442\u0438\u0439\u043d\u043e\u0435 \u0437\u0430\u043a\u043e\u043d\u043e\u0434\u0430\u0442\u0435\u043b\u044c\u0441\u0442\u0432\u043e, \u043f\u043e\u043c\u043e\u0433\u0430\u044e\u0449\u0435\u0435 \u043f\u0440\u0435\u0434\u043e\u0442\u0432\u0440\u0430\u0442\u0438\u0442\u044c \u043f\u0435\u0440\u0435\u0434\u043e\u0437\u0438\u0440\u043e\u0432\u043a\u0443 \u0433\u0435\u0440\u043e\u0438\u043d\u043e\u043c \u0438 \u043b\u0435\u043a\u0430\u0440\u0441\u0442\u0432\u0430\u043c\u0438, \u043e\u0442\u043f\u0443\u0441\u043a\u0430\u0435\u043c\u044b\u043c\u0438 \u043f\u043e \u0440\u0435\u0446\u0435\u043f\u0442\u0443<\/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\/ru\/resource\/fda-issues-guidance-for-developing-abuse-deterrent-opioids\/\" \/>\n<meta property=\"og:locale\" content=\"ru_RU\" \/>\n<meta property=\"og:type\" content=\"article\" \/>\n<meta property=\"og:title\" content=\"FDA Issues 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