{"id":382991,"date":"2025-12-31T17:12:06","date_gmt":"2025-12-31T17:12:06","guid":{"rendered":"https:\/\/www.newsbeep.com\/au\/382991\/"},"modified":"2025-12-31T17:12:06","modified_gmt":"2025-12-31T17:12:06","slug":"us-fda-approves-vanda-pharmaceuticals-motion-sickness-drug","status":"publish","type":"post","link":"https:\/\/www.newsbeep.com\/au\/382991\/","title":{"rendered":"US FDA approves Vanda Pharmaceuticals&#8217; motion sickness drug"},"content":{"rendered":"<p>Dec 30 (Reuters) &#8211; Vanda Pharmaceuticals <a data-testid=\"Link\" target=\"_blank\" referrerpolicy=\"no-referrer-when-downgrade\" href=\"https:\/\/www.reuters.com\/markets\/companies\/VNDA.O\" rel=\"noopener nofollow\" class=\"text-module__text__0GDob text-module__inherit-color__PhuPF text-module__inherit-font__1P1hv text-module__inherit-size__EyiQW link-module__link__INqxZ link-module__underline_default__-okuC link-module__with-icon__qlg76\">(VNDA.O), opens new tab<\/a> said on Tuesday its drug for the prevention of motion-induced vomiting was approved by the U.S. health regulator, becoming the first treatment for the condition to receive the nod in more than 40 years.<\/p>\n<p>The company expects to launch the drug, Nereus, in the coming months.<\/p>\n<p data-testid=\"promo-box\" class=\"text-module__text__0GDob text-module__dark-grey__UFC18 text-module__regular__qJJtA text-module__small__sph8i body-module__base__o--Cl body-module__small_body__gOmDf article-body-module__promo-box__hVl8h\"> Sign up  <a data-testid=\"Link\" referrerpolicy=\"no-referrer-when-downgrade\" href=\"https:\/\/www.reuters.com\/business\/healthcare-pharmaceuticals\/us-fda-approves-vanda-pharmaceuticals-motion-sickness-drug-2025-12-30\/undefined?location=article-paragraph&amp;redirectUrl=%2Fbusiness%2Fhealthcare-pharmaceuticals%2Fus-fda-approves-vanda-pharmaceuticals-motion-sickness-drug-2025-12-30%2F\" class=\"text-module__text__0GDob text-module__inherit-color__PhuPF text-module__inherit-font__1P1hv text-module__inherit-size__EyiQW link-module__link__INqxZ link-module__underline_default__-okuC\" rel=\"nofollow noopener\" target=\"_blank\">here.<\/a><\/p>\n<p>Motion-induced vomiting is a response triggered by mixed signals between the eyes, inner ear and body sensors, during activities such as boating, driving or flying.<\/p>\n<p>The U.S. Food and Drug Administration&#8217;s approval was based on two late-stage studies with a total of 681 patients, in which the drug, also known as tradipitant, had significantly reduced vomiting.<\/p>\n<p>It works by blocking a brain receptor linked to nausea and vomiting.<\/p>\n<p>&#8220;Sales of tradipitant solely in this indication could exceed $100 million annually at peak in the U.S. alone,&#8221; said H.C. Wainwright analyst Raghuram Selvaraju.<\/p>\n<p>Other approved treatments to prevent motion sickness are Viatris&#8217; <a data-testid=\"Link\" target=\"_blank\" referrerpolicy=\"no-referrer-when-downgrade\" href=\"https:\/\/www.reuters.com\/markets\/companies\/VTRS.O\" rel=\"noopener nofollow\" class=\"text-module__text__0GDob text-module__inherit-color__PhuPF text-module__inherit-font__1P1hv text-module__inherit-size__EyiQW link-module__link__INqxZ link-module__underline_default__-okuC link-module__with-icon__qlg76\">(VTRS.O), opens new tab<\/a> prescription scopolamine patch, Transderm Scop, WellSpring Pharmaceutical&#8217;s Bonine and Prestige Consumer Healthcare&#8217;s <a data-testid=\"Link\" target=\"_blank\" referrerpolicy=\"no-referrer-when-downgrade\" href=\"https:\/\/www.reuters.com\/markets\/companies\/PBH.N\" rel=\"noopener nofollow\" class=\"text-module__text__0GDob text-module__inherit-color__PhuPF text-module__inherit-font__1P1hv text-module__inherit-size__EyiQW link-module__link__INqxZ link-module__underline_default__-okuC link-module__with-icon__qlg76\">(PBH.N), opens new tab<\/a> Dramamine.<\/p>\n<p>The FDA had originally placed a partial clinical hold on Vanda&#8217;s tradipitant in December 2018, citing the need for additional six-month chronic toxicity studies in dogs due to the classification of motion sickness as a chronic condition.<\/p>\n<p>The agency lifted the clinical hold on December 4, calling motion sickness an acute condition and dropping the study requirement.<\/p>\n<p>Vanda licensed tradipitant from Eli Lilly <a data-testid=\"Link\" target=\"_blank\" referrerpolicy=\"no-referrer-when-downgrade\" href=\"https:\/\/www.reuters.com\/markets\/companies\/LLY.N\" rel=\"noopener nofollow\" class=\"text-module__text__0GDob text-module__inherit-color__PhuPF text-module__inherit-font__1P1hv text-module__inherit-size__EyiQW link-module__link__INqxZ link-module__underline_default__-okuC link-module__with-icon__qlg76\">(LLY.N), opens new tab<\/a> in 2012 and has been testing it for several uses, including motion sickness, a stomach disorder called gastroparesis, and nausea caused by certain diabetes drugs.<\/p>\n<p>The company did not immediately respond to a Reuters request for a comment on the drug&#8217;s pricing.<\/p>\n<p data-testid=\"SignOff\" class=\"text-module__text__0GDob text-module__dark-grey__UFC18 text-module__regular__qJJtA text-module__extra_small__8Buss body-module__full_width__kCIGb body-module__extra_small_body__Bfz20 sign-off-module__text__LQAMP\">Reporting by Siddhi Mahatole and Puyaan Singh in Bengaluru; Editing by Shilpi Majumdar<\/p>\n<p data-testid=\"Body\" dir=\"ltr\" class=\"text-module__text__0GDob text-module__dark-grey__UFC18 text-module__regular__qJJtA text-module__small__sph8i body-module__base__o--Cl body-module__small_body__gOmDf article-body-module__element__5eCce article-body-module__trust-badge__5mS3f\">Our Standards: <a data-testid=\"Link\" target=\"_blank\" referrerpolicy=\"no-referrer-when-downgrade\" href=\"https:\/\/www.thomsonreuters.com\/en\/about-us\/trust-principles.html\" rel=\"noopener nofollow\" class=\"text-module__text__0GDob text-module__dark-grey__UFC18 text-module__medium__2Rl30 text-module__small__sph8i link-module__link__INqxZ link-module__underline_default__-okuC link-module__with-icon__qlg76\">The Thomson Reuters Trust Principles., opens new tab<\/a><\/p>\n<p><a href=\"https:\/\/www.reutersagency.com\/en\/licensereuterscontent\/?utm_medium=rcom-article-media&amp;utm_campaign=rcom-rcp-lead\" target=\"_blank\" dir=\"ltr\" class=\"button-module__link__A3sD0 button-module__secondary__70gBu button-module__round__QDFgq button-module__w_auto__Sem-F\" data-testid=\"LicenceContentButton\" rel=\"nofollow noopener\">Purchase Licensing Rights<\/a><\/p>\n","protected":false},"excerpt":{"rendered":"Dec 30 (Reuters) &#8211; Vanda Pharmaceuticals (VNDA.O), opens new tab said on Tuesday its drug for the prevention&hellip;\n","protected":false},"author":2,"featured_media":382992,"comment_status":"","ping_status":"","sticky":false,"template":"","format":"standard","meta":{"footnotes":""},"categories":[33],"tags":[204275,64,63,205941,205942,86319,204785,205943,204802,205957,205956,205955,97932,205953,205954,205944,137,205945,23020,490,205946,205947,204793,205937,57247,205948,205949,204790,205950,204801,205951,205940,205938,101308,205952,205939,2489],"class_list":["post-382991","post","type-post","status-publish","format-standard","has-post-thumbnail","category-medication","tag-amers","tag-au","tag-australia","tag-bact","tag-biodrg","tag-biz","tag-cmpny","tag-cprod","tag-destlita","tag-destohlt","tag-destousdnm","tag-destoushem","tag-gen","tag-govact","tag-govadm","tag-hea","tag-health","tag-heca","tag-legal","tag-medication","tag-medreg","tag-mrch","tag-namer","tag-nrlpaohlt","tag-phar","tag-phar1","tag-phmr","tag-publ","tag-regs","tag-reuters-legal","tag-rhpiapprovals","tag-rhpiregulatory","tag-rsbiregulatory-oversight","tag-sci","tag-topicpharma-healthcare-business-health","tag-topicpharma-healthcare-policy-regulation","tag-us"],"_links":{"self":[{"href":"https:\/\/www.newsbeep.com\/au\/wp-json\/wp\/v2\/posts\/382991","targetHints":{"allow":["GET"]}}],"collection":[{"href":"https:\/\/www.newsbeep.com\/au\/wp-json\/wp\/v2\/posts"}],"about":[{"href":"https:\/\/www.newsbeep.com\/au\/wp-json\/wp\/v2\/types\/post"}],"author":[{"embeddable":true,"href":"https:\/\/www.newsbeep.com\/au\/wp-json\/wp\/v2\/users\/2"}],"replies":[{"embeddable":true,"href":"https:\/\/www.newsbeep.com\/au\/wp-json\/wp\/v2\/comments?post=382991"}],"version-history":[{"count":0,"href":"https:\/\/www.newsbeep.com\/au\/wp-json\/wp\/v2\/posts\/382991\/revisions"}],"wp:featuredmedia":[{"embeddable":true,"href":"https:\/\/www.newsbeep.com\/au\/wp-json\/wp\/v2\/media\/382992"}],"wp:attachment":[{"href":"https:\/\/www.newsbeep.com\/au\/wp-json\/wp\/v2\/media?parent=382991"}],"wp:term":[{"taxonomy":"category","embeddable":true,"href":"https:\/\/www.newsbeep.com\/au\/wp-json\/wp\/v2\/categories?post=382991"},{"taxonomy":"post_tag","embeddable":true,"href":"https:\/\/www.newsbeep.com\/au\/wp-json\/wp\/v2\/tags?post=382991"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}