{"id":4305,"date":"2026-06-29T07:42:16","date_gmt":"2026-06-29T07:42:16","guid":{"rendered":"https:\/\/paksouch.com\/?p=4305"},"modified":"2026-06-29T07:42:16","modified_gmt":"2026-06-29T07:42:16","slug":"us-declines-to-approve-smoking-cessation-drug","status":"publish","type":"post","link":"https:\/\/paksouch.com\/?p=4305","title":{"rendered":"US declines to approve smoking-cessation drug"},"content":{"rendered":"\n


The US Food and Drug Administration (FDA) has declined to approve Achieve Life \u200bSciences\u2019 drug to treat nicotine dependence in adults, citing unresolved issues found \u200cat a third-party manufacturing facility and final product labeling that was not completed by the agency\u2019s action date.<\/strong><\/p>\n\n\n\n

The FDA did not identify any deficiencies related to the drug\u2019s clinical efficacy or safety \u200bin its complete response letter, Achieve added in its statement on Monday.<\/p>\n\n\n\n

The rejection \u200bdelays Achieve\u2019s bid to introduce another non-nicotine prescription option for adults trying \u2060to quit smoking, with FDA-approved choices still largely limited to Pfizer\u2019s Chantix and \u200bGSK\u2019s Zyban, apart from nicotine replacement products.<\/p>\n\n\n\n

The experimental drug, called cytisinicline, is a plant-derived compound \u200baimed at helping adults quit smoking by targeting nicotine receptors in the brain to reduce nicotine cravings and withdrawal symptoms, including irritability and sleep problems. Unlike nicotine replacement products such as patches, gums \u200band lozenges, it does not deliver nicotine.<\/p>\n\n\n\n

Shares of the company were up more than 10% \u200bin early trading.<\/p>\n\n\n\n

\u201cThe CRL was expected, but the absence of clinical efficacy or safety deficiencies is the \u200ckey \u2060positive, in our view, as it supports cytisinicline\u2019s approvability,\u201d H.C. Wainwright analyst Brandon Folkes said.<\/p>\n\n\n\n

Achieve said late-stage trials and safety studies involving over 1,500 participants showed cytisinicline helped more adults quit smoking than placebo, with benefits lasting through 24 weeks and no new \u200bsafety concerns identified in \u200blonger-term data.<\/p>\n\n\n\n

The company had \u2060earlier said it expected a complete response letter after its former third-party manufacturer received an FDA inspection classification requiring corrective action. \u200bThe issues were general manufacturing matters and not specific to cytisinicline, \u200bAchieve added.<\/p>\n\n\n\n

Achieve \u2060has since moved its manufacturing to U.S.-based Adare Pharma Solutions and plans to resubmit its application for cytisinicline in the fourth quarter of 2026, with potential FDA approval in the \u2060first \u200bhalf of 2027.<\/p>\n\n\n\n

Smoking cessation is a very large market \u200bthat has been underdeveloped for years, said Folkes, adding that he believes \u201ccytisinicline has the potential to re-activate\u201d it.<\/p>\n","protected":false},"excerpt":{"rendered":"

The US Food and Drug Administration (FDA) has declined to approve Achieve Life \u200bSciences\u2019 drug to treat nicotine dependence in adults, citing unresolved issues found..<\/p>\n","protected":false},"author":1,"featured_media":4306,"comment_status":"open","ping_status":"open","sticky":false,"template":"","format":"standard","meta":{"footnotes":""},"categories":[9],"tags":[],"class_list":["post-4305","post","type-post","status-publish","format-standard","has-post-thumbnail","hentry","category-health"],"featured_image_urls":{"full":["https:\/\/paksouch.com\/wp-content\/uploads\/2026\/06\/Screenshot-2026-06-29-124104-1.png",816,399,false],"thumbnail":["https:\/\/paksouch.com\/wp-content\/uploads\/2026\/06\/Screenshot-2026-06-29-124104-1-150x150.png",150,150,true],"medium":["https:\/\/paksouch.com\/wp-content\/uploads\/2026\/06\/Screenshot-2026-06-29-124104-1-300x147.png",300,147,true],"medium_large":["https:\/\/paksouch.com\/wp-content\/uploads\/2026\/06\/Screenshot-2026-06-29-124104-1-768x376.png",768,376,true],"large":["https:\/\/paksouch.com\/wp-content\/uploads\/2026\/06\/Screenshot-2026-06-29-124104-1.png",816,399,false],"1536x1536":["https:\/\/paksouch.com\/wp-content\/uploads\/2026\/06\/Screenshot-2026-06-29-124104-1.png",816,399,false],"2048x2048":["https:\/\/paksouch.com\/wp-content\/uploads\/2026\/06\/Screenshot-2026-06-29-124104-1.png",816,399,false]},"author_info":{"info":["admin"]},"category_info":"Health<\/a>","tag_info":"Health","comment_count":"0","_links":{"self":[{"href":"https:\/\/paksouch.com\/index.php?rest_route=\/wp\/v2\/posts\/4305","targetHints":{"allow":["GET"]}}],"collection":[{"href":"https:\/\/paksouch.com\/index.php?rest_route=\/wp\/v2\/posts"}],"about":[{"href":"https:\/\/paksouch.com\/index.php?rest_route=\/wp\/v2\/types\/post"}],"author":[{"embeddable":true,"href":"https:\/\/paksouch.com\/index.php?rest_route=\/wp\/v2\/users\/1"}],"replies":[{"embeddable":true,"href":"https:\/\/paksouch.com\/index.php?rest_route=%2Fwp%2Fv2%2Fcomments&post=4305"}],"version-history":[{"count":1,"href":"https:\/\/paksouch.com\/index.php?rest_route=\/wp\/v2\/posts\/4305\/revisions"}],"predecessor-version":[{"id":4307,"href":"https:\/\/paksouch.com\/index.php?rest_route=\/wp\/v2\/posts\/4305\/revisions\/4307"}],"wp:featuredmedia":[{"embeddable":true,"href":"https:\/\/paksouch.com\/index.php?rest_route=\/wp\/v2\/media\/4306"}],"wp:attachment":[{"href":"https:\/\/paksouch.com\/index.php?rest_route=%2Fwp%2Fv2%2Fmedia&parent=4305"}],"wp:term":[{"taxonomy":"category","embeddable":true,"href":"https:\/\/paksouch.com\/index.php?rest_route=%2Fwp%2Fv2%2Fcategories&post=4305"},{"taxonomy":"post_tag","embeddable":true,"href":"https:\/\/paksouch.com\/index.php?rest_route=%2Fwp%2Fv2%2Ftags&post=4305"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}