June 2 (Reuters) – Cingulate said on Tuesday that the \u200cU.S. Food and Drug Administration \u200cdeclined to approve its drug to \u200btreat attention deficit hyperactivity disorder.<\/p>\n
The FDA issued a complete response letter seeking additional information \u200crelated to \u2060manufacturing and controls, but did not flag any \u2060concerns about the drug’s safety or effectiveness, Cingulate said.<\/p>\n
The drug, \u200bCTx-1301, is \u200bdesigned \u200bto target ADHD, \u200cwhich can cause persistent inattention, hyperactivity and impulsive behavior, often affecting children and continuing into adulthood.<\/p>\n
The once-daily tablet form of \u200cdexmethylphenidate, an ingredient \u200bused in several \u200bapproved \u200bADHD drugs, aims to \u200cimprove attention and \u200breduce impulsive \u200band restless behavior in patients with ADHD.<\/p>\n
(Reporting by Kunal \u200bDas \u200cand Siddhi Mahatole in Bengaluru; \u200bEditing by Vijay Kishore \u200band Diti Pujara)<\/p>\n","protected":false},"excerpt":{"rendered":"June 2 (Reuters) – Cingulate said on Tuesday that the \u200cU.S. Food and Drug Administration \u200cdeclined to approve…\n","protected":false},"author":3,"featured_media":839245,"comment_status":"","ping_status":"","sticky":false,"template":"","format":"standard","meta":{"footnotes":"","_share_on_mastodon":"0"},"categories":[34],"tags":[84138,343816,6434,210,343817,1060,67,132,68],"class_list":["post-839244","post","type-post","status-publish","format-standard","has-post-thumbnail","category-medication","tag-attention-deficit-hyperactivity-disorder","tag-cingulate","tag-food-and-drug-administration","tag-health","tag-impulsive-behavior","tag-medication","tag-united-states","tag-unitedstates","tag-us"],"share_on_mastodon":{"url":"https:\/\/pubeurope.com\/@us\/116680859918424566","error":""},"_links":{"self":[{"href":"https:\/\/www.europesays.com\/us\/wp-json\/wp\/v2\/posts\/839244","targetHints":{"allow":["GET"]}}],"collection":[{"href":"https:\/\/www.europesays.com\/us\/wp-json\/wp\/v2\/posts"}],"about":[{"href":"https:\/\/www.europesays.com\/us\/wp-json\/wp\/v2\/types\/post"}],"author":[{"embeddable":true,"href":"https:\/\/www.europesays.com\/us\/wp-json\/wp\/v2\/users\/3"}],"replies":[{"embeddable":true,"href":"https:\/\/www.europesays.com\/us\/wp-json\/wp\/v2\/comments?post=839244"}],"version-history":[{"count":0,"href":"https:\/\/www.europesays.com\/us\/wp-json\/wp\/v2\/posts\/839244\/revisions"}],"wp:featuredmedia":[{"embeddable":true,"href":"https:\/\/www.europesays.com\/us\/wp-json\/wp\/v2\/media\/839245"}],"wp:attachment":[{"href":"https:\/\/www.europesays.com\/us\/wp-json\/wp\/v2\/media?parent=839244"}],"wp:term":[{"taxonomy":"category","embeddable":true,"href":"https:\/\/www.europesays.com\/us\/wp-json\/wp\/v2\/categories?post=839244"},{"taxonomy":"post_tag","embeddable":true,"href":"https:\/\/www.europesays.com\/us\/wp-json\/wp\/v2\/tags?post=839244"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}