{"id":1000,"date":"2025-07-20T09:37:46","date_gmt":"2025-07-20T09:37:46","guid":{"rendered":"https:\/\/sitefansalaran.ir\/En\/?p=1000"},"modified":"2025-07-20T09:37:46","modified_gmt":"2025-07-20T09:37:46","slug":"fda-staff-raises-efficacy-concerns-for-otsukas-ptsd-combination-treatment","status":"publish","type":"post","link":"https:\/\/sitefansalaran.ir\/En\/2025\/07\/20\/fda-staff-raises-efficacy-concerns-for-otsukas-ptsd-combination-treatment\/","title":{"rendered":"FDA staff raises efficacy concerns for Otsuka&#8217;s PTSD combination treatment"},"content":{"rendered":"<p style=\"text-align: justify;\">The U.S. Food and Drug Administration&#8217;s reviewers on Wednesday raised efficacy concerns over the use of Otsuka Pharma&#8217;s (4578.T), opens new tab drug in combination with Viatris&#8217; (VTRS.O), opens new tab Zoloft for the treatment of adults with PTSD.<\/p>\n<p style=\"text-align: justify;\">The FDA staff&#8217;s assessment comes ahead of a meeting of its independent experts on Friday, who will make recommendations on whether the regulator should approve the use of the drug, brexpiprazole, in combination with Zoloft for treating PTSD.<\/p>\n<p style=\"text-align: justify;\">The FDA staff cited inconsistent trial results and a modest treatment effect that may not be clinically meaningful as reasons for the efficacy concerns.<\/p>\n<p style=\"text-align: justify;\">Otsuka&#8217;s application was based on the data from one mid-stage and two late-stage studies testing the combination of brexpiprazole and Zoloft in PTSD patients compared to sertraline monotherapy.<br \/>\nThe reviewers, however, noted that one of the late-stage studies failed to show statistically significant differences in treatment response between the two groups.<\/p>\n<p style=\"text-align: justify;\">They also added that the mid-stage study had statistical and methodological concerns.<br \/>\nPTSD is a mental health condition that can develop after a traumatic event, causing symptoms including flashbacks, nightmares and severe anxiety.<\/p>\n<p style=\"text-align: justify;\">Brexpiprazole, sold under the brand name of Rexulti, is approved in the U.S. to treat agitation in patients with Alzheimer&#8217;s disease as well as for adults with major depressive disorder and schizophrenia.<\/p>\n<p style=\"text-align: justify;\">The drug is being co-developed by Otsuka and Danish drugmaker Lundbeck (<a href=\"http:\/\/HLUNa.CO\" target=\"_blank\" rel=\"noopener\">https:\/\/hluna.co\/<\/a>) , opens new tab.<br \/>\nOtsuka had said earlier this year the FDA, which was originally set to decide on the company&#8217;s treatment by February 8, delayed its decision to seek the advisory panel&#8217;s input on certain issues related to the marketing application.<br \/>\nThe agency has not set a new action date for the drug.<\/p>\n<p style=\"text-align: justify;\">If approved, the combination drug would be the first PTSD treatment to gain U.S. approval in over 30 years after Zoloft and GSK&#8217;s (GSK.L), opens new tab Paxil.<\/p>\n","protected":false},"excerpt":{"rendered":"<p>The U.S. Food and Drug Administration&#8217;s reviewers on Wednesday raised efficacy concerns over the use of Otsuka Pharma&#8217;s (4578.T), opens new tab drug in combination with Viatris&#8217; (VTRS.O), opens new tab Zoloft for the treatment of adults with PTSD. The FDA staff&#8217;s assessment comes ahead of a meeting of its independent experts on Friday, who [&hellip;]<\/p>\n","protected":false},"author":2,"featured_media":1001,"comment_status":"open","ping_status":"open","sticky":false,"template":"","format":"standard","meta":{"footnotes":""},"categories":[40],"tags":[137],"class_list":{"0":"post-1000","1":"post","2":"type-post","3":"status-publish","4":"format-standard","5":"has-post-thumbnail","7":"category-sitefansalaran-food-and-drug","8":"tag-fda-staff-raises-efficacy-concerns-for-otsukas-ptsd-combination-treatment"},"yoast_head":"<!-- This site is optimized with the Yoast SEO Premium plugin v24.7 (Yoast SEO v25.4) - https:\/\/yoast.com\/wordpress\/plugins\/seo\/ -->\n<title>FDA staff raises efficacy concerns for Otsuka&#039;s PTSD combination treatment - sitefansalarn<\/title>\n<meta name=\"description\" content=\"FDA staff raises efficacy concerns for Otsuka&#039;s PTSD combination treatment\" \/>\n<meta name=\"robots\" content=\"index, follow, max-snippet:-1, max-image-preview:large, max-video-preview:-1\" \/>\n<link rel=\"canonical\" href=\"https:\/\/sitefansalaran.ir\/En\/2025\/07\/20\/fda-staff-raises-efficacy-concerns-for-otsukas-ptsd-combination-treatment\/\" \/>\n<meta property=\"og:locale\" content=\"en_US\" \/>\n<meta property=\"og:type\" content=\"article\" \/>\n<meta property=\"og:title\" content=\"FDA staff raises efficacy concerns for Otsuka&#039;s PTSD combination treatment\" \/>\n<meta property=\"og:description\" content=\"FDA staff raises efficacy concerns for Otsuka&#039;s PTSD combination treatment\" \/>\n<meta property=\"og:url\" content=\"https:\/\/sitefansalaran.ir\/En\/2025\/07\/20\/fda-staff-raises-efficacy-concerns-for-otsukas-ptsd-combination-treatment\/\" \/>\n<meta property=\"og:site_name\" content=\"sitefansalarn\" \/>\n<meta property=\"article:published_time\" content=\"2025-07-20T09:37:46+00:00\" \/>\n<meta property=\"og:image\" content=\"https:\/\/sitefansalaran.ir\/En\/wp-content\/uploads\/2025\/07\/33.jpg\" \/>\n\t<meta property=\"og:image:width\" content=\"975\" \/>\n\t<meta property=\"og:image:height\" content=\"650\" \/>\n\t<meta property=\"og:image:type\" content=\"image\/jpeg\" \/>\n<meta name=\"author\" content=\"dorost\" \/>\n<meta name=\"twitter:card\" content=\"summary_large_image\" \/>\n<meta name=\"twitter:label1\" content=\"Written by\" \/>\n\t<meta name=\"twitter:data1\" content=\"dorost\" \/>\n\t<meta name=\"twitter:label2\" content=\"Est. reading time\" \/>\n\t<meta name=\"twitter:data2\" content=\"2 minutes\" \/>\n<script type=\"application\/ld+json\" class=\"yoast-schema-graph\">{\"@context\":\"https:\/\/schema.org\",\"@graph\":[{\"@type\":\"WebPage\",\"@id\":\"https:\/\/sitefansalaran.ir\/En\/2025\/07\/20\/fda-staff-raises-efficacy-concerns-for-otsukas-ptsd-combination-treatment\/\",\"url\":\"https:\/\/sitefansalaran.ir\/En\/2025\/07\/20\/fda-staff-raises-efficacy-concerns-for-otsukas-ptsd-combination-treatment\/\",\"name\":\"FDA staff raises efficacy concerns for Otsuka's PTSD combination treatment - 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