{"id":7332,"date":"2015-01-26T06:42:57","date_gmt":"2015-01-26T06:42:57","guid":{"rendered":"https:\/\/www.nicox.com\/nicox-reunion-pre-nda-positive-avec-la-fda-sur-le-dossier-clinique-de-lac-170\/"},"modified":"2015-01-26T06:42:57","modified_gmt":"2015-01-26T06:42:57","slug":"nicox-reunion-pre-nda-positive-avec-la-fda-sur-le-dossier-clinique-de-lac-170","status":"publish","type":"post","link":"https:\/\/www.nicox.com\/fr\/nicox-reunion-pre-nda-positive-avec-la-fda-sur-le-dossier-clinique-de-lac-170\/","title":{"rendered":"Nicox : r\u00e9union pr\u00e9-NDA positive avec la FDA sur le dossier clinique de l\u2019AC-170"},"content":{"rendered":"<p>Sophia Antipolis, France.<\/p>\n<p>Nicox S.A. (NYSE Euronext Paris : COX), soci\u00e9t\u00e9 internationale sp\u00e9cialis\u00e9e en ophtalmologie, annonce aujourd\u2019hui avoir tenu une r\u00e9union pr\u00e9alable \u00e0 la soumission d\u2019un dossier de <em>New Drug Application<\/em> (NDA) positive avec la <em>Food and Drug Administration<\/em> (FDA) am\u00e9ricaine pour l\u2019AC-170. L\u2019AC-170 est une nouvelle formulation de c\u00e9tirizine pour application topique oculaire, d\u00e9velopp\u00e9e pour le traitement du prurit oculaire (d\u00e9mangeaisons) associ\u00e9 aux conjonctivites allergiques. Cette r\u00e9union pr\u00e9-NDA avait pour objectif de discuter du dossier clinique de l\u2019AC-170. Sur la base des donn\u00e9es d\u2019efficacit\u00e9 et de s\u00e9curit\u00e9 d\u2019emploi disponibles, la FDA a recommand\u00e9 la soumission d\u2019un dossier de NDA. Une seconde r\u00e9union pr\u00e9-NDA est pr\u00e9vue au cours du premier trimestre 2015 pour discuter du dossier Chimie, Fabrication et Contr\u00f4les (<em>Chemistry, Manufacturing and Controls<\/em>, CMC). Nicox tiendra le march\u00e9 inform\u00e9 en temps opportun de la date pr\u00e9visionnelle du d\u00e9p\u00f4t de dossier.<\/p>\n<p>L\u2019AC-170 est une nouvelle formulation de c\u00e9tirizine d\u00e9velopp\u00e9e pour une premi\u00e8re application topique oculaire. La c\u00e9tirizine est un antagoniste de seconde g\u00e9n\u00e9ration des r\u00e9cepteurs H1 de l\u2019histamine et un antihistaminique de premier plan commercialis\u00e9 depuis plus de vingt-cinq ans. L\u2019AC-170 a \u00e9t\u00e9 d\u00e9velopp\u00e9 pour le traitement du prurit oculaire associ\u00e9 aux conjonctivites allergiques par Aciex Therapeutics, Inc., une filiale de Nicox depuis octobre 2014.<\/p>\n","protected":false},"excerpt":{"rendered":"<p>Sophia Antipolis, France. Nicox S.A. (NYSE Euronext Paris : COX), soci\u00e9t\u00e9 internationale sp\u00e9cialis\u00e9e en ophtalmologie, annonce aujourd\u2019hui avoir tenu une r\u00e9union pr\u00e9alable \u00e0 la soumission d\u2019un dossier de New Drug Application (NDA) positive avec la Food and Drug Administration (FDA) am\u00e9ricaine pour l\u2019AC-170. L\u2019AC-170 est une nouvelle formulation de c\u00e9tirizine pour application topique oculaire, d\u00e9velopp\u00e9e [&hellip;]<\/p>\n","protected":false},"author":7,"featured_media":0,"comment_status":"closed","ping_status":"closed","sticky":false,"template":"","format":"standard","meta":{"_acf_changed":false,"footnotes":""},"categories":[32,16],"tags":[],"class_list":["post-7332","post","type-post","status-publish","format-standard","hentry","category-actualites","category-actualites-et-media"],"acf":[],"yoast_head":"<!-- This site is optimized with the Yoast SEO plugin v27.3 - https:\/\/yoast.com\/product\/yoast-seo-wordpress\/ -->\n<title>Nicox : r\u00e9union pr\u00e9-NDA positive avec la FDA sur le dossier clinique de l\u2019AC-170 - Nicox<\/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.nicox.com\/fr\/nicox-reunion-pre-nda-positive-avec-la-fda-sur-le-dossier-clinique-de-lac-170\/\" \/>\n<meta property=\"og:locale\" content=\"fr_FR\" \/>\n<meta property=\"og:type\" content=\"article\" \/>\n<meta property=\"og:title\" content=\"Nicox : r\u00e9union pr\u00e9-NDA positive avec la FDA sur le dossier clinique de l\u2019AC-170 - Nicox\" \/>\n<meta property=\"og:description\" content=\"Sophia Antipolis, France. Nicox S.A. (NYSE Euronext Paris : COX), soci\u00e9t\u00e9 internationale sp\u00e9cialis\u00e9e en ophtalmologie, annonce aujourd\u2019hui avoir tenu une r\u00e9union pr\u00e9alable \u00e0 la soumission d\u2019un dossier de New Drug Application (NDA) positive avec la Food and Drug Administration (FDA) am\u00e9ricaine pour l\u2019AC-170. 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