{"id":20857,"date":"2013-02-01T11:50:09","date_gmt":"2013-02-01T11:50:09","guid":{"rendered":"http:\/\/i-base.info\/htb\/?p=20857"},"modified":"2013-02-07T08:06:30","modified_gmt":"2013-02-07T08:06:30","slug":"darunavir-new-oral-suspension-and-800-mg-formulations-approved-in-eu","status":"publish","type":"post","link":"https:\/\/i-base.info\/htb\/20857","title":{"rendered":"Darunavir: new oral suspension and 800 mg formulations approved in EU"},"content":{"rendered":"<p><strong>Two new formulations of darunavir were recently granted EU approval.<\/strong><\/p>\n<p>On 25 October 2012, the EU approved a 100 mg\/ml oral suspension of darunavir (Prezista), and the use of darunavir co-administered with low dose ritonavir, in combination with other ARVS, for the treatment of HIV-1 in treatment-experienced paediatric patients age 3 years and above, weighing at least 15 kg body weight. [1]<\/p>\n<p>The approval is based on a 48-week analysis of ARIEL, a Phase II, open-label trial to evaluate pharmacokinetics, safety, tolerability and antiviral activity of darunavir in combination with low dose ritonavir in treatment-experienced HIV-1 infected children from 3 to &lt; 6 years of age.<\/p>\n<p>The EU also recommended approval of the darunavir 100 mg\/ml oral suspension for use in patients who are unable to swallow tablets, providing an additional way to receive treatment.<\/p>\n<p>The EU approval for the oral suspension was also based on TMC114-C169: a Phase I open label randomised crossover trial in healthy participants to compare the oral bioavailability to that of the 300 mg tablet formulation with 100 mg ritonavir under fasted and fed conditions.<\/p>\n<p>The second formulation, is an 800 mg darunavir tablet that reduces the pill count for standard daily adult dose from 2 x 400 mg to 1 x 800 mg tablet. Both formulations require boosting by 100 mg ritonavir.<\/p>\n<p>Both are now available in the UK.<\/p>\n<p>References:<\/p>\n<ol>\n<li>Jannsen-Cilag press release. Darunavir (Prezista) oral suspension receives EU approval for young children with HIV-1 infection. 25 October 2012.<\/li>\n<li>Jannsen-Cilag press release. FDA Approves New 800mg PREZISTA (darunavir) tablet. (9 November 2012).<br \/>\n<a href=\"http:\/\/www.jnj.com\/connect\/news\/all\/fda-approves-new-800mg-prezista-darunavir-tablet\">http:\/\/www.jnj.com\/connect\/news\/all\/fda-approves-new-800mg-prezista-darunavir-tablet<\/a><\/li>\n<\/ol>\n","protected":false},"excerpt":{"rendered":"<p>Two new formulations of darunavir were recently granted EU approval. On 25 October 2012, the EU approved a 100 mg\/ml oral suspension of darunavir (Prezista), and the use of darunavir co-administered with low dose ritonavir, in combination with other ARVS, &hellip;<\/p>\n","protected":false},"author":2,"featured_media":0,"comment_status":"open","ping_status":"closed","sticky":false,"template":"","format":"standard","meta":{"footnotes":""},"categories":[3],"tags":[],"class_list":["post-20857","post","type-post","status-publish","format-standard","hentry","category-antiretrovirals"],"_links":{"self":[{"href":"https:\/\/i-base.info\/htb\/wp-json\/wp\/v2\/posts\/20857","targetHints":{"allow":["GET"]}}],"collection":[{"href":"https:\/\/i-base.info\/htb\/wp-json\/wp\/v2\/posts"}],"about":[{"href":"https:\/\/i-base.info\/htb\/wp-json\/wp\/v2\/types\/post"}],"author":[{"embeddable":true,"href":"https:\/\/i-base.info\/htb\/wp-json\/wp\/v2\/users\/2"}],"replies":[{"embeddable":true,"href":"https:\/\/i-base.info\/htb\/wp-json\/wp\/v2\/comments?post=20857"}],"version-history":[{"count":0,"href":"https:\/\/i-base.info\/htb\/wp-json\/wp\/v2\/posts\/20857\/revisions"}],"wp:attachment":[{"href":"https:\/\/i-base.info\/htb\/wp-json\/wp\/v2\/media?parent=20857"}],"wp:term":[{"taxonomy":"category","embeddable":true,"href":"https:\/\/i-base.info\/htb\/wp-json\/wp\/v2\/categories?post=20857"},{"taxonomy":"post_tag","embeddable":true,"href":"https:\/\/i-base.info\/htb\/wp-json\/wp\/v2\/tags?post=20857"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}